The data involved more than 3 million women from 2002 to 2009. The women ranged in age from 13 to 33 with at least six months of enrollment in insurance and prescription drug coverage. The study found that 18 percent of teenage girls ages 13 to 18 filled prescriptions for birth control pills in 2009, up year after year since 2002. This was a 50 percent increase among commercially insured teenagers and a 29 percent increase among teenagers on Medicaid. The No. 1 choice in birth control pills among teenaged women was Yaz.

When Yaz was first approved for marketing in the United States it was touted as more than for pregnancy prevention. Bayer’s ads said the oral contraceptive could quell irritability caused by premenstrual syndrome (PMS) and manage breakouts of acne. It wasn’t long before women began asking for the pill by name, and it became the top selling birth control pill in America.

But the Food and Drug Administration (FDA) soon caught wind of those ads, and ordered Bayer to run a series of commercials to clarify that the pill was not approved for PMS, but for the more serious premenstrual dysphoric disorder, or PMDD. Bayer was also told to clearly state the risks associated with the drug, including the risk for blood clots, heart attacks, strokes and gallbladder damage.

While all birth control pills carry a risk for blood clots, studies began to suggest that Yaz, a combination of ethinyl estradiol and drospirenone, put women at an even greater risk for the serious side effects. As a result, thousands of women and their loved ones have filed lawsuits against Bayer arguing they were not warned of the dangerous and life-threatening risks associated with Yaz.

SOURCE: Yaz Lawsuit › Yaz is most popular birth control pill among teenagers

The study, published in the Journal of Clinical Endocrinology and Metabolism, included data from more than 1,800 women between the ages of 16 and 44 on birth control pills and summarizes six previous studies related to heart attack risk in women taking the so-called mini-pills. Brand name mini-pills include Micronor and Ovrette.

More women take the combined estrogen-and-progestin pills than the mini-pills, and that is where researchers say the results become more skewed. The combined pills carry an increased risk for blood clots, which can lead to heart attacks, strokes, pulmonary embolism (blood clot in the lungs), and deep vein thrombosis, all of which can be life threatening.

Some studies suggest that some varieties of combined oral contraceptives put women at greater risk for blood clots, such as Yaz, a fourth-generation pill that includes the hormones ethinyl estradiol and drospirenone.

Women who are high risk for heart disease, such as women who smoke or have high blood pressure or a family history of blood clots, may consider switching to progestin-only products, or going off birth control pills altogether.

SOURCE: Yaz Lawsuit › Mini-pill may be safer than combination birth control pills

The study is the first to provide a comprehensive review of diagnosing, imaging and treating CVT. Researchers found that CVT disproportionately affects pregnant women or women taking birth control pills, as well as people 45 years of age and younger. Oral contraceptives put women at an even greater risk, and researchers recommend that patients with suspected CVT undergo blood tests to determine if they have an inherited or acquired factor in the blood that predisposes them to blood clots.

The safety labels of all birth control pills warn users of a risk for blood clots. However, studies suggest that some birth control pills put users at an even greater risk. Yaz and Yasmin are a type of “fourth generation” birth control pill that combines the hormones ethinyl estradiol and drospirenone. Propelled by pricy marketing campaigns, the pills quickly became the most popular type of oral contraceptive in the country, with many women asking their doctors for the pills by name.

Since the pills were introduced, the Food and Drug Administration (FDA) has received hundreds of reports of women who have been seriously injured while using Yaz and Yasmin. Problems include blood clots, heart attacks, strokes and even gallbladder damage. Bayer HealthCare, makers of Yaz and Yasmin, now face thousands of lawsuits from women claiming they were not adequately warned that using the pills could put their lives in danger.

SOURCE: Yaz Lawsuit › Birth control pills can cause rare form of stroke

Perhaps Lucy was fooled by the aggressive advertising campaign launched in early the 2000s by Bayer Healthcare, the makers of Yaz. The ads touted the birth control pill’s strengths, such as fighting irritability from premenstrual syndrome and clearing up troublesome acne, and downplayed the serious side effects associated with the drug. Those side effects include blood clots, such as pulmonary embolism and deep vein thrombosis, as well as heart attack, stroke, and gallbladder damage. The deceptive advertising for Yaz paid off for Bayer. The pills became the top selling oral contraceptive in America.

But soon Bayer couldn’t escape the bad press that was growing from reports of these serious side effects happening in women and in some cases resulting in death. Bayer, instead, claimed the pills were no more dangerous than other birth control pills. Meanwhile, the Food and Drug Administration (FDA) ordered Bayer to run a new set of ads for Yaz clearly stating the harm the drugs may cause. The information came too late for Lucy.

“I am at home right now with very low energy and barely able to care for my children. Ladies, it is not worth it. My children were almost without a mother. I am unable to take anything without hormones now for the rest of my life, not to mention the painful treatments and the prescriptions I have to use now,” Lucy warned. “Please do not risk your life!”

* Not her real name

SOURCE: Yaz Lawsuit › Doctors blame woman’s blood clots on Yaz birth control

Yaz is considered a fourth-generation birth control pill and contains a combination of hormones known as ethinyl estradiol and drospirenone. Drospirenone also works as a diuretic.

Since Bayer Healthcare introduced Yaz to the market in the early 2000s, the company has launched three other birth control bills with similar formulations. The pills have become a favorite among young American and Canadian women, thanks to a massive marketing campaign claiming the pills help fight the symptoms of premenstrual syndrome and clear up acne.

The ads also effectively downplayed the serious side effects associated with the drug, which include blood clots, pulmonary embolism, deep vein thrombosis, heart attack, stroke and gallbladder damage. Soon after the commercials hit the airwaves, the Food and Drug Administration (FDA) ordered Bayer to rerun ads clearly stating the serious side effects that the drugs could cause.

Some experts question the use of drospirenone in the pills, claiming the diuretic can cause a condition that leads to irregular heart rhythms. Those arrhythmias can cause serious health problems, including blood clots, heart attacks and strokes.

The revision ads from Bayer came too late for thousands of women, including Amie and Lauren. Both women have joined the more than 2,000 other women who claim they were injured by Yaz and filed a lawsuit against Bayer.

SOURCE: Yaz Lawsuit › Deceptive ads lead to two more lawsuits against makers of Yaz

Carole Ann wasn’t the only woman swayed by the playful advertisements – Yaz soon became the best selling birth control pill in the nation. However, Carole Ann found out the hard way that women like her were being fooled by Bayer Healthcare, the makers of Yaz. She suffered a blood clot in her lungs, known as a pulmonary embolism.

Soon after the ads began, the Food and Drug Administration (FDA) slapped Bayer Healthcare with heavy fines and ordered the company to run a series of retraction ads that clearly stated the benefits of the pills as well as the risks involved.

“You may have seen some Yaz commercials recently that were not clear,” the revised ads say. “The FDA wants us to correct a few points in those ads.” Those corrections specify that the pills are not approved to tackle symptoms of PMS, but rather premenstrual dysphoric disorder, or PMDD, a condition with severe emotional and physical premenstrual symptoms. The ads also more clearly reported serious side effects, including blood clot conditions such as pulmonary embolism and deep vein thrombosis, heart attacks, stroke, and gallbladder damage.

The revision ads came too late for Carole Ann. She took the pills and suffered a life-threatening blood clot in her lungs. Carole Ann is one of thousands of women in the United States and Canada who has filed a lawsuit against Bayer Healthcare alleging that the pharmaceutical company did not adequately warn her of the dangers of taking the pill. She claims she would not have taken the pill had she known of the dangers. She is seeking compensatory and punitive damages including economic damages, economic damages and medical expenses, attorney’s fees, costs and other relief.

SOURCE: Yaz Lawsuit › NJ woman files lawsuit against makers of Yaz birth control

All oral contraceptives carry a slight risk for blood clots, which can lead to heart attack, stroke, deep vein thrombosis or pulmonary embolism. But two separate European studies that suggest Yaz and Yasmin, made by Bayer HealthCare, put users at greater risk for blood clots than other birth control pills.

The “fourth generation” pills were the first to contain two hormones, ethinyl estradiol and drospirenone, the latter active ingredient also acts as a diuretic. The Food and Drug Administration has since approved two other birth control pills with the same combination of hormones plus folic acid. Those pills are marketed as Bayaz and Safyral.

In an effort to quell public panic, the Society of Obstetricians and Gynaecologists of Canada issued a statement saying Bayer’s pills posed no greater risk than other birth control pills. But some medical experts say the European studies shouldn’t be dismissed. One of the studies, published last year in the British Medical Journal, showed a six times greater risk of blood clots in women using Yasmin versus other types of birth control pills.

The group cited a third study of nearly 60,00 users of various birth control pills, which showed no real difference in risk among the pills; however, that study was sponsored by Bayer, makers of Yaz and Yasmin. Critics say Bayer’s vested interest in the outcome of the study could have influenced the results.

SOURCE: Yaz Lawsuit › Yaz, Yasmin lawsuits could cause public panic, unwanted pregnancies

But the honeymoon would soon end for Bayer, as reports of potentially fatal side effects from Yaz and Yasmin began to surface. Bayer was also slapped by the Food and Drug Administration (FDA) with fines and ordered to spend millions on new ads to clarify its benefits (for example, the pills are approved for the treatment of premenstrual dysphoric disorder, PMDD, and not PMS) and clearly state the risk for side effects such as blood clots.

While Bayer contends that its pills are no more dangerous than other birth control pills, thousands of women have filed lawsuits against the company claiming the pills are far more dangerous than other pills and that Bayer failed to adequately warn them. Serious and life-threatening side effects associated with Yaz and Yasmin include blood clots, heart attacks, strokes, deep vein thrombosis, pulmonary embolism, and gallbladder damage.

Despite the reports of serious problems, Yaz and Yasmin remain on the market and are still being used by hundreds and thousands of women. Warn your friends and family members of the dangers associated with Yaz and Yasmin by using social media tools such as Facebook and Twitter. Your friends and followers may appreciate the warning.

SOURCE: Yaz Lawsuit › Alert your friends to the dangers of Yaz, Yasmin

“SAFYRAL and Beyaz are part of Bayer’s growing women’s health franchise, and these new products reinforce our commitment to providing women with various contraceptive options,” said Leslie North, Vice President of Marketing, Women’s HealthCare, Bayer HealthCare Pharmaceuticals.

Bayer also offers the blockbuster birth control pills Yaz and Yasmin, both of which contain the diuretic drospirenone but no folic acid. The pills have come under fire in recent years because of mounting reports of serious side effects associated with the pills.

While all oral contraceptives put women at a slightly increased risk of developing blood clots, some studies show that the combination hormone with diuretic puts women at even greater risk. The pills also increase a woman’s risk of suffering from gallbladder problems that in many cases have resulted in surgery to remove the gallbladder.

Bayer faces thousands of lawsuits from women who have suffered serious health consequences – such as heart attacks, strokes, deep vein thrombosis, and gallbladder damage – while on Yaz and Yasmin. The company says that Beyaz and SAFYRAL have the same safety profile as Yaz and Yasmin.

SOURCE: Yaz Lawsuit › Bayer launches second birth control pill with folic acid

The day before she died she was treated for a knee injury, but the injury wouldn’t have caused her death, her mother, Joan Cummins, told Lehigh Valley Life. “There’s just really no reason that a healthy young woman who had a knee injury would have developed this.” Cummins has another theory as to what caused her daughter’s death – her birth control pills. “She was on Yaz … for acne,” she said. “All you have to do is Google that and look at all the lawsuits.”

Now Cummins has joined thousands of other people affected by Yaz and filed a lawsuit of her own against Bayer Healthcare, the makers of Yaz. Cummins alleges that Bayer knew Yaz was more dangerous than other oral contraceptives and put women at greater risk for life-threatening blood clots but failed to adequately warn consumers. Bayer maintains that Yaz is no more dangerous than other birth control pills.

Last April, however, Bayer agreed to update the safety labels on Yaz and the birth control pill Yasmin to warn of “the relative risk of developing venous thrombosis.” Cummins said the warning is too little, too late. “(Michelle) was 18 years old, completely healthy, at college with the world at her fingertips,” she said. “Any medication we take, we’re so used to seeing may cause … all these side effects. You just think, ‘That won’t happen. My daughter will be fine…’”

SOURCE: Yaz Lawsuit › Mother sues Yaz maker for daughter’s untimely death

Bayer cleverly launched Yaz in 2006, promising that the new formulation birth control pill – a combination of ethinyl estradiol and drospirenone – not only prevented pregnancy but also helped treat premenstrual symptoms and acne. Women began to ask their doctors for the pill by name, skyrocketing sales. Soon after, a review by the Food and Drug Administration (FDA) found the ads for Yaz to be misleading. The agency accused Bayer of over-stating the drug’s benefits and covering up its risks, and ordered the company to run correction ads. But the new formulation of active ingredients offered by Yaz had already hit superstar status among women.

Gradually, however, reports of women suffering sometimes fatal blood clots and other serious health problems began to surface. Bayer is now facing more than 2,000 lawsuits from women who allege they were not adequately warned that Yaz could cause them serious harm.

Rising out of the flurry of lawsuits, Bayer seems determined not to lose ground in all the bad press from Yaz. It is launching Natazia. This pill contains a new type of estrogen that has never been used before in an oral contraceptive. It hits the market with a Black Box Warning on its safety label, informing that women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal genital bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors (benign or malignant) or liver disease, or who are pregnant, not to take Natazia. For women who don’t fall under any of the risk categories, is Natazia worth trying?

National Public Radio this week responded to the news of Natazia this way: “It’s a good time to look at the Yaz saga and see if it has anything to teach women and their doctors when they choose a contraceptive.” Indeed. The moral of this story: Beware of the latest and greatest drugs unless there’s some reason that the ones that have been around for a while don’t work for you.

SOURCE: Yaz Lawsuit › Bayer launches new birth control pill amid a flurry of Yaz lawsuits

Sure, the pharmaceutical company sells the top selling birth control pills in the nation – Yaz and Yasmin. The pills have earned the company a reported $1.5 billion in 2009 alone. Both Yaz and Yasmin contain drospirenone, a diuretic, which no other brand of oral contraceptive has. This special formulation, Bayer says, makes the pills an effective treatment for premenstrual dysphoric disorder (PMDD) and moderate acne. The company launched an advertising campaign for Yaz in 2007 and 2008 that resulted in skyrocketing sales.

It wasn’t long before the Food and Drug Administration (FDA) found those ads to be misleading. The agency accused Bayer of exaggerating the pills’ benefits and camouflaging the risks behind busy graphics. In February 2009, Bayer agreed to spend $20 million to run a series of corrective ads. They also agreed to submit future ads for the pills to the FDA for approval. But the damage had already been done. Thousands of women began suffering from blood clots, heart attacks and strokes, and soon after began filing lawsuits against Bayer saying they were not adequately warned of the risks.

Now, Bayer wants to assure us that they are a trusted source for women with questions about their contraception. I think I’ll leave the medical advice to my physician instead.

SOURCE: Yaz Lawsuit › Should you really trust Bayer for contraception advice?

“Our goal is to evaluate objectively the risks and benefits of demedicalizing contraceptive care, with an eye toward improving access to OCs (oral contraceptives) and potentially other hormonal contraceptive methods by making them available without a prescription,” a statement from the nonprofit advocacy group reads.

The group says there is substantial literature available on oral contraceptives that show birth control pills meet most of the Food and Drug Administration’s criteria for OTC status. “The drug’s benefits outweigh the risk for women of reproductive age; the potential for misuse or abuse is low; a consumer can easily self-diagnose the condition for which the pills are indicated; and directions for use are straightforward.”

Birth control pills have a host of minor side effects including vision changes, breast tenderness, fluid retention, weight gain, acne, headaches, depression and anxiety. But women who use estrogen-containing birth control pills are at a 3- to 6-fold increased risk of developing blood clots. Blood clots may lead to deep vein thrombosis, heart attack or stroke.

Some studies suggest that different types of birth control pills can put women at an even greater risk of blood clots. Most notably is Bayer HealthCare’s blockbuster birth control pill Yaz, also known as Yasmin and by the generic ocella. Yaz is the top-selling birth control pill in the country, yet few women realize they are at risk of blood clots until it is too late. To date, more than 1,100 lawsuits have been filed against Bayer by women who allege they were not adequately warned by the drug company that taking Yaz put them at greater risk of serious injury.

Making oral contraceptives available OTC does have benefits. It will give women greater control over their birth control choices, and that could lead to easier access to higher rates of initiation, continuation and fewer gaps in use, thereby “potentially leading to an overall decrease in rates of unintended pregnancy and abortion,” the organization’s statement reads.

For now, the Working Group on Oral Contraceptives Over-the-Counter will carry out several activities, including research, engaging in public education and discussion, and building consensus on key issues. “We will initiate dialogue with professional medical organizations, host a meeting to gauge support for this issue among organizations representing diverse groups of women, and create informational materials on the safety of OCs.”

SOURCE: Yaz Lawsuit › Group advocates to make birth control pills available OTC

The women’s claims are backed up by a recent study published in the British Medical Journal that found women on Yaz and Yasmin had double the risk of blood clots and strokes compared to other brands of birth control pills. Yaz and Yasmin are the only oral contraceptives that contain a diuretic known as drospirenone. The study attributed the increased risk of blood clots to the diuretic.

“It appears as though there is a higher risk with Yasmin compared to the others,” Dr. Ravi Patel told KGET 17 News. “But it doesn’t mean the others don’t have a risk. The others may have a four-fold risk, this may have a six-fold risk compared to a normal individual of getting blood clots if they are not taking birth control or hormonal replacements of any kind.”

KGET 17 News contacted Bayer for comment but the company did not return the call. Bayer has said previously that Yaz and Yasmin carry the same risk of blood clots and strokes as other brands of birth control pills.

SOURCE: Yaz Lawsuit › More women join lawsuit against Yaz, Yasmin makers

Kathy Perea

Kathy says the attacks began shortly after she started taking the Yasmin birth control pill. “I would wake up in the middle of the night and it would feel like someone had hit me with a baseball bat in my rib,” she said. So she stopped taking the pill. Her symptoms did not go away. That’s when her doctor told her the damage had already been done. Her gallbladder was damaged and had to be removed.

Yasmin, also known by the brand name Yaz and the generic Ocella, is one of the top selling birth control pills in the country. It is the only one that combines a hormone with a diuretic. While Bayer HealthCare, the maker of Yasmin, says the pill carries the same risks as other birth control pills, women like Kathy say they believe Yasmin is more dangerous and that they were not adequately warned by the drug company of the serious side effects that could occur with taking the once-daily pill.

To date, Bayer faces more than 1,100 lawsuits from women who allege they were harmed by the drugs. Many claim to have suffered damage to their gallbladder. Others claim the pills caused them to develop life-threatening blood clots and other serious medical conditions.

Though Kathy is feeling better she says she still suffers from occasional pain after eating. She blames Yasmin for threatening her life, and she wants justice. “I have five kids I have to support financially and I had to miss days of work. I had to have surgery,” Kathy said through tears. “That’s money coming out of my pocket for something they didn’t tell me was going to happen to me.”

SOURCE: Yaz Lawsuit › Woman blames Yasmin for damaging her gallbladder

But instead of seeking medical attention, Sara limped around in pain for three days as her leg began to swell from the knee down. “I should have listened to my gut and asked my father to take me to the doctor right then,” she said. “However, I felt silly about my worry because of my Achilles tendonitis and my young age.”

When her condition continued to worsen, Sara finally visited a doctor. The diagnosis surprised her. She had blood clot in her leg and needed immediate medical attention.

Blood clots can be deadly. What Sara learned is that despite her young age, she had common risk factors of blood clots – traveling in an airplane where she sat sedentary for hours, and using birth control pills. Oral contraceptives can increase the risk of blood clots due to the effect or dose of hormones, either estrogen or progestin. While the packaging on birth control pills may outline this risk, many lawsuits have been filed against makers of birth control pills by women who claim they were not adequately warned about the dangers in using the pills. To date, Bayer HealthCare faces more than 1,100 lawsuits for its oral contraceptives Yaz and Yasmin.

As part of her treatment, Sara had to discontinue use of her birth control. “I can never take birth control pills again and was told that if I get pregnant I will have to take a ‘blood thinner’ because changes during pregnancy make the blood clot more easily,” she said, adding a warning to other young women like her. “If you are contemplating use of birth control pills, make sure to discuss your family history (especially related to blood clots) as well as the adverse effects of birth control with your doctor.

“Take your life into your own hands.”

SOURCE: Yaz Lawsuit › Young woman warns others about birth control pills and blood clot risk

Dawn Varrechio

Like many women, Dawn was taking Yaz birth control pills, the most popular oral contraceptive in America. What she didn’t realize is that by taking Yaz she was putting herself at greater risk for life-threatening blood clots. Last year, two studies published in the British Medical Journal found women on Yaz to be at greater risk of developing blood clots than on other forms of birth control. Bayer HealthCare, makers of Yaz, sponsored two previous studies that discount those claims, arguing that Yaz doesn’t increase blood clot risk any more than other brands of birth control pills.

Yaz, also known by the brand name Yasmin and the generic Ocella, is the only birth control pill that contains drospirenone, a diuretic, and ethinyl estradiol. The pills were touted not only for pregnancy prevention but also for the treatment of severe acne and premenstrual dysphoric disorder, or PMDD. Yaz soared in popularity, becoming a blockbuster money maker for Bayer.

But as Bayer began collecting its profits, reports of serious injuries and deaths in women who took the drug began pouring in. Bayer now faces more than a thousand lawsuits from women who say Yaz caused them to suffer from health problems such as heart attacks, strokes, pulmonary embolisms, blood clots, deep vein thrombosis, and gallbladder disease.

Survivors can only hope their problems don’t return. “It’s scary,” said Dawn, who says she now worries about the long-term effects Yaz will have on her. “It’s really scary.”

SOURCE: Yaz Lawsuit › Woman worries about long-term effects of Yaz

Irina Shiryaeva

Blood clots are one of the most common causes of death in the United States, second only to cancer. Despite their prevalence, only six percent of Americans know the symptoms and risk factors of blood clots – including pulmonary embolism and deep vein thrombosis, or blood clots that commonly affect the leg veins.

According to the National Alliance for Thrombosis and Thrombophilia, there are many known causes for blood clots to form. Those factors include prolonged bed rest or inactivity, such as long plane rides. The lack of movement can cause reduced circulation in the legs. Most surgical procedures or physical trauma can also increase one’s risk. Other situations that increase one’s risk of blood clots includes pregnancy, oral contraceptives and hormone replacement therapy.

Estrogen does not cause blood clots, but it does dramatically increase a woman’s risk. Most birth control pills, which include an estrogen and progestin, increase a woman’s risk of blood clots by as much as three- to four-fold. About one woman out of 300 taking oral contraceptives will develop a blood clot. Women on birth control pills who have additional risk factors – such as taking a long-distance trip or flight – are at even greater risk of developing potentially life threatening blood clots.

While manufacturers of birth control pills and even birth control patches have warnings on their label of the increased risk of blood clots, many women who have been harmed by them say the warnings weren’t adequate enough. Several lawsuits have been filed against the makers of Yaz, Yasmin and its generic, Ocella; and Johnson & Johnson, maker of the Ortho Evra birth control patch, has paid millions to settle lawsuits from women who have suffered blood clots after using the patches.

Unfortunately, it’s too late for Irina, who leaves behind a husband and 3-year-old son.

Source: News Observer

SOURCE: Yaz Lawsuit › Birth control pills, long plane flights increase risk of blood clots

“I’d been popping a drug every morning for years knowing only what my doctor had said: the Pill ‘regulated’ my periods. I had always backed it up with condoms. I had taken it through my teens when I wasn’t having sex. It was an unthinking habit. It took one last switch to another brand, an eye-opening two-month break, then six months back on the Pill to make me realize what it had been doing to my body and my mind throughout my adult life. I came to understand why I felt so very sick,” she writes in a recent column recognizing the Pill’s 50th anniversary.

Over the course of a decade, the writer took four different birth control pills, including Yasmin, a pill also marketed as Yaz in the United States and the UK. Made by Bayer HealthCare, the oral contraceptive has become one of the most widely used birth control pills in the world.

“I was taking the brand Yasmin, which I had requested from my doctor after reading in magazines about its amazing skin-clearing and weight-loss side effects. My sisters and many of my friends were also taking it. Yasmin was marketed aggressively in the US, and news of its supposed benefits spread quickly to young women in the UK. The New York Times recently described Yasmin as the ‘go-to drug brand for women,’ which has been sold as a ‘quality-of-life’ treatment,” Grigg-Spall wrote.

Last year, the Food and Drug Administration (FDA) penalized Bayer for overstating the benefits and covering up the risks of Yaz and Yasmin and ordered Bayer to produce commercials that clarified the uses and risks of the drugs. Bayer now faces more than 1,000 lawsuits from women who say they were harmed by the drugs but were not adequately warned of the risks involved. That information was enough to convince Grigg-Spall to look for other alternatives in contraception.

“The Pill is handed out to women with acne, PMS, irregular periods, heavy periods. The Pill has developed into a medication for the disease of being female. In place of changing society, society decided to fix women. On the 50th anniversary of the Pill we should stop celebrating the fictionalized revolution of the Sixties and turn our attention to the rebellion underway today. Young women are ditching the Pill in droves. They have come to see that the Pill can be harmful, as is the sugar coating used to make us swallow.”

SOURCE: Yaz Lawsuit › Columnist: 50th anniversary of The Pill nothing to celebrate

Like Natazia, Yaz and Yasmin were considered a new type of birth control pill. Yaz was approved by the FDA in 2006; Yasmin was approved in 2001. Both pills combine ethinyl estradiol and drospirenone, a diuretic not found in any other birth control product. The pills are marketed for the added benefit of treating severe acne and premenstrual dysphoric disorder, or PMDD. Both Yaz and Yasmin soared to the top spot on Bayer’s pharmaceutical sales list, bringing it more than $600 million in 2008 alone. It seemed almost too good to be true.

Then came the reports of serious injuries in women who took Yaz and Yasmin. The diuretic was believed to raise the potassium in women’s blood to dangerous levels, causing blood clots to form. Serious adverse event reports began pouring in, including heart attack, cardiac arrhythmias, stroke, pulmonary embolism, kidney failure, seizures, deep vein thrombosis (DVT), gallbladder disease, hepatic adenomas and even sudden death. The company now faces hundreds of lawsuits from women who say they were not adequately warned by Bayer of the serious health risks with using Yaz or Yasmin.

Prior to approval, two studies were conducted on the effectiveness of Natazia with a sample of 1,867 women. The most common side effects reported were irregular bleeding, headaches, nausea and vomiting.

SOURCE: Yaz Lawsuit › Yaz, Yasmin makers get approval for new birth control pill

“I hate the pill. Hormonal contraception, which covers birth control pills and nearly every other highly effective method on the market, murders my libido. I say that with as much certainty as I can, given the murky, multi-variate thing that is the human sex drive,” she writes in a post titled Why I hate the pill. “I’ve experimented with several pills, hoping that any slight variation in hormonal ingredients would yield a contraceptive that worked without neutering me. Each doused my interest in sex as completely as the other. Although a libido-destroying pill does wonders to lower your pregnancy risk, it’s also done a number on my relationships, self-esteem and emotional well-being.”

Sealey says she didn’t find relief from her problem when switching to other forms of birth control. Nothing seemed to be the right “fit.” But she makes a good point. “If you’re like me, you assume that someone, somewhere is figuring all of this out — that there will be a new kind birth control discovered or invented at some point because that’s just how human progress rolls on. I mean, they’re already working on another iPad. Surely, some lab rat is putting the finishing touches on the next breakthrough in contraception.”

Unfortunately, Sealey says, any prospect for the development of innovative birth control methods have stopped dead in their tracks. “According to a 2008 report by Harper and several colleagues, public and private funds for contraceptive research have dried up in recent years. Most pharmaceutical companies have withdrawn from investing in contraceptive R&D, perhaps due to fears of costly personal injury litigation. And those fears aren’t necessarily unfounded. A reported 1,100 lawsuits have been filed in the United States against Bayer HealthCare alone, mostly by women claiming health problems such as blood clots, strokes, heart attacks and gall bladder disease after taking the popular pills Yaz and Yasmin.”

Perhaps the key is not finding new methods, but making the ones currently marketed to women safer to use.

SOURCE: Yaz Lawsuit › Women deserve safer options in birth control

The biggest disappointment on Bayer’s books was a 10.2 percent decrease in profits from sales of its blockbuster oral contraceptive, Yaz, also known as Yasmin and Yasminelle. Sales of the birth control pill, which combines drospirenone and ethinyl estradiol, have suffered in the U.S., according to Bayer, because “the discussion surrounding the thrombosis risk of contraceptives containing drospirenone.” Bayer says that it continues to believe that the risk profile is comparable to that of other combinations and “Yaz and Yasmin remain good choices for contraception when used as directed.”

Bayer is facing hundreds of lawsuits in the U.S. and beyond, claiming the company didn’t adequately warn consumers of an increased risk of serious health problems including stroke, heart attack, gallbladder problems and blood clots associated with Yaz.

As a result of the company’s weak pharmaceutical line, Bayer has lowered its sales guidance for the health care unit for 2010 to 3 percent from 5 percent. According to Bayer chairman Werner Wenning, “we are optimistic about the future and intend to build on the positive developments prior to 2009.”

SOURCE: Yaz Lawsuit › Bayer’s drug sales suffer due to bad press on Yaz blood clot risk

The news story focused on lawsuits filed against Bayer Healthcare over its birth control pills Yaz and Yasmin (ocella) and claims that the pill caused women, including young and otherwise healthy women, to suffer from serious and sometimes fatal blood clots.

“The studies don’t give a clear answer if Yaz and Yasmin are ‘the cause of health problems, including deep vein thrombosis (blood clots in the deep veins), strokes, heart attacks and gallbladder disease’ as they’re being accused of doing,” Garcia writes.

But Hull countered with a personal story. “It (Yaz) should scare the heck out of women! My wife began taking Yaz shortly after it hit the market in 2006, and a little over a year later she suffered a bilateral pulmonary embolism that devastated her. It caused a cascade of injuries that culminated in pulmonary arrest, multiple cardiac arrests, multiple strokes and ultimately an anoxic brain injury. At 46 years old she went from being vibrant and active to lying flat on her back and being unable to do anything for herself,” he responded. “Not worth it.”

SOURCE: Yaz Lawsuit › Husband of Yaz victim says pills were ‘catastrophic in our lives’

Yaz, and Bayer’s equivalent Yasmin, as well as the generic Ocella, are considered fourth-generation birth control pills. They contain a new type of synthetic progestin, drospirenone, that acts as a diuretic. The pills are promoted to not only prevent pregnancies but to also treat severe acne and premenstrual dysphoric disorder, or PMDD.

As of November, the Food and Drug Administration had received 993 reports of pulmonary embolism (blood clots in the lungs), 487 reports of deep vein thrombosis (blood clots in the deep veins), and 229 reports of other blood clots from birth control pills containing drospirenone.

Bayer stands by the safety of its blockbuster birth control pill, saying the pills carry the same health risk as any other type of oral contraceptive. However, two separate studies in the British Medical Journal claimed women were at as much as 6.3 times higher risk of developing blood clots when taking Yaz, Yasmin or Ocella. Recently, Bayer updated the labels of Yaz and Yasmin to include a risk of developing life-threatening blood clots.

SOURCE: Yaz Lawsuit › Yaz, Yasmin can be dangerous to your health

Bayer HealthCare

Yaz and Yasmin, as well as the generic Ocella, contain drospirenone, a diuretic that the plaintiffs claim elevated potassium in their bloodstream, which put them at greater risk for serious and sometimes fatal complications from blood clots, such as heart attack, pulmonary embolism, deep vein thrombosis and stroke. Diuretics can also cause significant problems with the gallbladder and may lead to gallbladder removal.

The lawsuits allege Bayer’s birth control pills put users at greater risk for serious adverse events; however, the company maintains that a woman’s risk of developing blood clots while taking Yaz or Yasmin is similar to other oral contraceptives.

Yaz and Yasmin were Bayer’s top-selling pharmaceutical last year, ringing in sales of $1.64 billion.

SOURCE: Yaz Lawsuit › Bayer adds new information about blood clot risk to Yaz, Yasmin labels

According to the Southeastern Texas Record, three east Texas women filed lawsuits against Merck & Co. Inc., alleging that they relied on misrepresentations of the device and as a result suffered injuries. All claim the manufacturers failed to warn them of the greater risk of venous thromboembolism, including deep vein thrombosis and pulmonary embolism.

The Nuvaring controversy is just another incident in which women claim that makers of contraceptives failed to adequately warn them of the increased risk of serious injury when using the birth control. Johnson & Johnson recently paid $68 million to settle thousands of cases against women who say they suffered from blood clots and other serious events after using the Ortho Evra birth control patch. As a result, the company no longer actively markets the patch.

Bayer Healthcare has found itself in a similar mess with its biggest money-maker, Yaz, a birth control pill also known by the brand name Yasmin. Plaintiffs claim the hormone-plus-diuretic formulation is more dangerous than other oral contraceptives, causing life-threatening blood clots and gallbladder problems.

SOURCE: Yaz Lawsuit › Lawsuits claim Nuvaring is just as dangerous as Ortho Evra patch, Yaz

Bayer has an obvious vested interest in the outcome of that survey. The drug company makes one of the nation’s most popular oral contraceptives, Yaz. It is also known by the brand name Yasmin and the generic brand Ocella. Bayer has hit snags over the years marketing its blockbuster birth control pill.

First, the Food and Drug Administration (FDA) fined the drug maker and ordered they spend millions on a revamped advertising campaign after the agency deemed its Yaz commercials were misleading and were not being forthright about the drug’s life-threatening side effects.

Next came the lawsuits – an estimated 1,100 to date – from women who say they were not adequately warned of the dangers in taking Yaz. These women suffered from serious health problems including blood clots, heart attacks, kidney failure, gallbladder disease and seizures. Some complications resulted in death or disability.

Bayer’s response to the mounting lawsuits has been unwavering. The company contends it will “defend itself vigorously against these lawsuits.”

Source: Daily Record

SOURCE: Yaz Lawsuit › Bayer has vested interest in survey results

Yaz, also known by the brand name Yasmin and the generic brand Ocella, is a different type of oral contraceptive that combines ethinyl estradiol with the diuretic drospirenone. Some health professionals say that the addition of drospirenone in birth control raised the potassium level in users’ blood. This increase in potassium can lead to hyperkalemia and cause heart rhythm disturbances that can cause blood clots that can cause sudden cardiac death or pulmonary embolism or strokes. At least 50 women and their family members have filed suit against the Bayer claiming the drug manufacturer knew of the potential risks but did not properly warn women.

Bayer has argued that it sufficiently warned women that Yaz, like all birth control pills, carries a risk of life-threatening side effects.

Last year, Bayer, after getting its hand slapped by the Food and Drug Administration (FDA), shelled out $20 million to air advertisements to clarify the drug’s use. The FDA argued the company’s previous ads misled consumers by broadening the drug’s indication. The commercials promoted Yaz as a treatment for PMS, a condition for which it was not indicated, and acne, a condition in which Yaz has a limited indication. The FDA also said that the drug’s risk information was not stated clearly and was clouded with distracting visuals, background music and other “competing modalities.”

Meanwhile, Yaz remains on the market and continues to rake in money for Bayer. Yaz scored $9 billion in the first nine months of 2009, a sizable increase over the $600 million it made in 2008.

SOURCE: Yaz Lawsuit › Bayer pockets billions from dangerous birth control pill Yaz

The Tennessee Tech student had been taking the drug for about six months when she suddenly passed out in the shower. Her roommate called 911, and when Leah briefly regained consciousness, her roommate got her mother, Traci, on the phone. “Leah told me that she was scared, and that she was tingling all over,” Traci tells WREG-TV. “I told her it was going to be OK, that me and daddy was coming.”

But they arrived too late. Leah died less than an hour after she collapsed. Doctors say what killed her was a blood clot in her lung, also known as a pulmonary embolism. “How does this happen to a healthy 20-year-old lady?” Traci asks. The answer may be in the birth control pill she was taking.

The diuretic drospirenone that is in Yaz can cause an increase in potassium levels in the blood, which can lead to hyperkalemia, a condition that causes heart rhythm disturbances that can cause blood clots that can trigger cardiac death or pulmonary embolism or strokes. Diuretics also can cause significant problems with the gallbladder, leading to gallbladder removal.

The Mayfields have joined at least 50 other women injured by Yaz and filed a lawsuit against Bayer. The lawsuit alleges that the drug maker ignored the increased risks of Yaz and kept it on the market to enjoy mounting profits. Now Traci wants to warn others of the dangers of Yaz.

“(Leah) didn’t have to die,” Traci says. “She didn’t have to die because of a pill.

SOURCE: Yaz Lawsuit › Mother warns others of the dangers of Yaz

What Adrienne didn’t know was that while the combination birth control pill had benefits, it also increased users’ risk of serious side effects such as heart attack, cardiac arrhythmias, stroke, pulmonary embolism, blood clots, kidney failure, seizures, deep vein thrombosis, gallbladder disease, hepaic adenomas and sudden death. Adrienne believes Ocella caused her to suffer from a stroke and other serious side effects. She claims it also left her at an increased risk of developing additional side effects such as blood clots in the deep veins and lungs.

On December 28, 2009, Adrienne and her husband Kenneth, filed a lawsuit against Bayer HealthCare, the manufacturer of Yaz, and other manufacturers and distributors, seeking $75,000 from each defendant, as well as punitive damages and compensation for medical care, pain, suffering, and mental anguish.

Adrienne’s lawsuit is one of hundreds from women who say they have suffered serious side effects from Yaz, Yasmin and Ocella. The Food and Drug Administration (FDA) reports that between 2004 and 2008, more than 50 deaths have been attributed to the drugs.

SOURCE: Yaz Lawsuit › Woman claims Yaz/Yasmin/Ocella caused her stroke

Yaz incorporates a unique progestin, drospirenone, with ethinyl estradiol, a more common ingredient used in birth control drugs. Many women who have been injured after starting a Yaz regimen allege that the drug poses a multitude of serious risks, which Bayer downplayed in its Yaz marketing campaigns.

The U.S. Food and Drug Administration admonished Bayer in October 2008, citing the company for “significant deviations” in its promotion of Yaz. The complaint largely centered on the understatement of the drug’s risks and the overstatement of its benefits, including the treatment of conditions for which the drug was not approved. The misleading marketing campaign is frequently cited in lawsuits brought against Bayer by former Yaz users.

Some of the most serious side effects associated with Yaz include stroke, heart arrhythmia cardiac arrest, deep vein thrombosis and other forms of blood clotting, pulmonary embolism, gallbladder disease, kidney damage or failure, and sudden death.

Judge Herndon told Southwestern Illinois’ Belleville News-Democrat that he may also conduct bellwether trials, a cluster of cases selected because they reflect the charges and allegations of the other lawsuits. The outcome of bellwether trials helps establish guidelines for other cases.

When a significant number of similar lawsuits, such as those being brought against Bayer over Yaz injuries, accumulate in federal courts, the Judicial Panel on Multidistrict Litigation normally moves to consolidate them in one U.S. District Court to avoid redundant efforts and inconsistent pre-trial rulings. The dynamics of these representative trials will then be considered in the evaluation of other cases.

SOURCE: Yaz Lawsuit › Southern Illinois district court to handle Yaz lawsuits

The plaintiff, who resides in Belpre, Ohio, had been taking Yaz for about a year when she developed deep vein thrombosis in her leg. She spent three days in the hospital, where like many other women who use Yaz, she was put on a regimen of blood thinners to dissolve the clot and reduce the swelling in her leg.

Deep vein thrombosis (DVT) is a very serious type of blood clot that can lead to serious complications and death if not treated properly. Clots that form a DVT can become dislodged, traveling through the bloodstream to the lungs and causing a pulmonary embolism, resulting in permanent damage to the lung. DVT can also cause stroke, cardiac arrest, and other potentially deadly conditions.

Yaz contains drospirenone, a synthetic progestin used in Yaz, Yasmin, and Ocella, which is a generic form of Yasmin. Drospirenone has been shown to increase potassium levels in some women who take the drug, which can lead to DVT and affect the function of several organs, including the heart.

The Ohio plaintiff’s lawsuit was filed in New Jersey Superior Court. The suit alleges that the plaintiff’s injuries were the result of Bayer’s failure to adequately warn consumers of the drug’s risks. Her attorney claims that Bayer knew Yaz to be more dangerous than other birth-control pills, but chose to downplay the drug’s hazards.

SOURCE: Yaz Lawsuit › Ohio mother sues Bayer, alleging Yaz caused blood clot

The plaintiff began taking Yaz after her gynecologist reassured her of the drug’s benefits and safety. After weeks of using Yaz, however, the woman began experiencing severe pain that sent her to the emergency room twice for general treatment and CT scans.

It took 13 hours for doctors to finally discover the problem. According to the Times, “In her left lung, the pulmonologist told her, was the largest blood clot they had ever seen and there were others in her right lung as well.”

The woman spent 6 days in the hospital as she was treated with 2 types of blood thinners to dissolve the clots in her lungs. Doctors expected a good recovery but told her that she might never be completely the same . Two weeks after the treatment, she told the Times that she is “incredibly tired most of the time.”

The plaintiff said that a couple of days after the treatment the severity of her situation suddenly hit her. “Wow, I almost died,” she told the Times. Now she strives to tell others about how Yaz affected her and has put the lives of so many other women in danger.

“It’s not just about women who are my age,” she told the Times, adding that lots of younger women are being seriously injured by the drug.

“There’s no reason for blood clots to be forming except for this pill and it’s a very scary situation,” she said.

Bayer has defended itself and Yaz against the allegations, pointing to the two Bayer-funded studies that showed the drug had a safety profile similar to other, more traditional oral contraceptives.

Another Yaz study, not funded by Bayer, found women who took Yaz to be more at risk for blood clots, heart attacks, and strokes. Those results were echoed by a more recent study published by the British Medical Journal in August.

SOURCE: Yaz Lawsuit › Recovering Maryland woman sues Bayer after Yaz nearly killed her

“She was short of breath. She was having severe chest pains and her face was changing colors,” Kraus told WTAE.

“She ended up going into cardiac arrest three times. One time it took 10 minutes to revive her. They eventually had to do emergency surgeries because they noticed there were two huge blood clots, one in each pulmonary artery,” Kraus said.

Kraus said that because of Yaz, her daughter now faces possibly lifelong struggles with pancreatitis, liver function problems, and acute kidney failure. Kraus and the other plaintiffs have requested a jury trial, more than $150,000 in compensation, attorney fees, court costs, and punitive damages.

Bayer Corporation, which is headquartered in Pittsburgh, defended itself from the allegations in a statement to WTAE.

“The complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all contraceptives. Bayer will defend itself vigorously against these lawsuits,” a company spokesman said.

The lawsuit, however, alleges that Bayer grossly downplayed the risks of Yaz in its advertising campaigns and that the number of adverse events caused by Yaz is at least 10 times more than the number reported incidents, possibly 100 times more.

“I just don’t want anybody else to see their child go through anything like this ever again,” Kraus told WTAE.

Source: http://www.thepittsburghchannel.com/

SOURCE: Yaz Lawsuit › Mother says Yaz nearly killed her daughter

When customers go to Google’s search engine and perform a search for information on Yaz or “the pill,” they will see this simple new ad format appear in the search results. Some sponsored links will appear at the top of the results in a yellowish box. One of the links will lead to Bayer’s website for Yaz and will contain a gray-text notice: “Click to see full safety and prescribing information, including boxed warning.”

Why is Bayer using this new format for Yaz? Because the U.S. Food and Drug Administration has warned pharmaceutical companies about using the text promos for drug advertising since they do not contain any warnings or disclaimers to customers about possible side effects, health risks, and other drawbacks.

Bayer clashed with the FDA last year over its Yaz advertisements. The company aired a couple of television commercials titled “Not Gonna Take It” and “Balloons” that promoted the drug for unapproved uses, downplayed its risks and side effects, and used competing music and visual to draw the viewer’s attention away from the safety information. The FDA ordered the ads off the air and requested that Bayer spend a minimum of $20 million on a “corrective” ad campaign.

Other drug companies, anxious to promote their drugs through Google’s sponsored links without being called out by the FDA, will no doubt keep a watchful eye on the agency’s reaction to the new Yaz links.

SOURCE: Yaz Lawsuit › Bayer tests Google’s new ad format for Yaz promotion

Development of gall stones and gall bladder disease are among the serious risks associated with the oral contraceptive Yaz. The drug has also been blamed for elevating the risk of cardiac arrhythmias and heart attack, stroke, pulmonary embolism, blood clots, kidney failure, seizures, deep vein thrombosis, hepatic adenomas and sudden death.

According to the lawsuit, 50 deaths attributed to the use of Yaz and Yasmin were reported to the U.S. Food and Drug Administration between the first quarter of 2004 and the third quarter of 2008.

The lawsuit alleges that Bayer markets Yaz and Yasmin “as providing the same efficacy as other birth control pills in preventing pregnancy, but with additional benefits,” rather than the higher risks the drugs pose.

“The foreseeable risks of the product exceeded the benefits associated with its design or formulation. Or they were more dangerous than an ordinary consumer would expect,” the lawsuit states.

The plaintiff seeks compensatory and punitive damages, medical expenses and economic damages, and attorney’s fees. Because Bayer ran a deceptive ad campaign for Yaz, hailing the drug for uses unapproved by the FDA while downplaying its risks, the plaintiff also seeks an unspecified amount of punitive damages.

Source: http://www.chicagonow.com/

SOURCE: Yaz Lawsuit › Chicago woman sues Bayer over Yaz-related injuries

“Even though I’m old, I don’t want the horrifying side effects of aging to prevent me from doing what I love,” Haskins, who just turned 30, jokes. “I want to walk with canoes, peel oranges, play fetch with my pup, and do stuff with horses,” she says while a montage of images pulled from actual television drug ads plays. In one of the ads Haskins shows, anatomy takes the form of bouncing water balloons; in another, people are made of pipes. After all, cute, cartoon-like illustrations help lighten ads for drugs that pose very serious side effects for some people.

Amusing as Haskins’ Target episode is, it effectively illustrates just how outlandish and just plain silly some pharmaceutical advertising can be.

It’s also not the first time that Haskins has featured drug commercials on Target: Women. Last year, she spoofed big pharma television ads for birth control drugs, noting how they are touted as a way to have fewer periods more than anything else.

“Fewer periods! Yay! Now we don’t have to leave the tribe and go sit in that hut for a week. That was a bummer,” Haskins says.

Drugs developed for one thing but marketed as a treatment for something else is a common ruse employed by some pharmaceutical companies to make their products more enticing. Negative disclosures about the drugs, such as the legally required information about side effects, may be washed out with distracting music and visuals. That was how Bayer advertised Yaz last year, before the Food and Drug Administration cited the company for false and misleading advertising and ordered a redo.

“You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads,” the presenter in the revised commercial says.

The Yaz advertisements spawned a number of video skits lampooning the drugmaker’s claims and the style in which they are presented: a group of girlfriends in a lively bar discussing side effects in a way that would never happen in real life. One woman, who says she “didn’t go to med school for nothing,” gives her friends an off the cuff and very clinical rundown of the drug’s risks while her friends listen intently.

Inserting herself into this scenario, Haskins asks “Does anyone think Stephanie is acting super weird right now?”

For all the risks attached to some blockbuster drugs, it’s good to see that the absurdity of drug advertising isn’t sliding by unnoticed.

SOURCE: Yaz Lawsuit › Comedian lampoons the absurdity of drug ads

The plaintiff claims that at the time, she was not aware the FDA had not approved Yaz for the treatment of skin conditions. In an extensive and aggressive marketing campaign, Bayer touted its birth control drug as an effective treatment for acne and symptoms associated with Premenstrual Syndrome (PMS) – conditions for which the FDA never tested or approved Yaz.

In October 2008, FDA officials warned Bayer that its Yaz ads intentionally mislead and confused viewers by overstating the drug’s effectiveness, overselling its benefits, and not adequately communicating the drug’s potential for serious side effects, including blood clots, cardiac arrest, and gallbladder disease. According to the FDA, the commercials used distracting visuals, multiple scene changes, and background music that effectively interfered with the audio presentation about the serious risks associated with the drug.

“Bayer promoted Yaz with the slogan ‘the difference a little chemistry can make,’” the plaintiff said. “What Bayer did not disclose was how negative that difference can be. Yaz gave me life-threatening injuries that have forever altered my life.”

After several months of Yaz therapy, the plaintiff developed an acute pain in her left shoulder and had difficulty breathing. A visit to the doctor revealed the plaintiff had developed blood clots in both her lungs. She was hospitalized immediately and treated successfully, but just one month later she developed gallstones and had to undergo surgery for their removal.

The plaintiff alleges that she “suffered months of anxiety and nausea related to (the) medical procedures and drugs given to treat the adverse side effects (she) developed from taking Yaz.”

The complaint charges that had Bayer properly warned patients about the dangers of using Yaz strictly as an acne treatment, the plaintiff could have avoided serious injury.

The lawsuit was filed in the Superior Court of New Jersey, where Bayer’s American operations are based. The plaintiff seeks an unspecified amount of compensatory damages.

SOURCE: Yaz Lawsuit › Injured by Yaz, SC nurse files lawsuit against Bayer

Pulmonary embolisms are blockages in one of the arteries leading to the lungs formed by a substance that has migrated through the bloodstream from another part of the body, commonly the legs. Clinical studies of Yaz conducted in Denmark and the Netherlands suggest a link between the Yaz ingredient drosperinone and a higher occurrence of blood clots than in women who took traditional contraceptives containing levonorgestrel.

A spokesperson for Bayer said that the company is cooperating with the investigation, but that it stood by the safety of its drug.

“A singular case, as tragic and sad as it is, does not indicate an increased risk for the whole group of women who take the pill,” Oliver Renner, a Bayer spokesman, told Bloomberg. “Studies have shown that the risk isn’t higher for Yaz than for other oral contraceptives.”

Of course, Bayer’s spokesperson dismisses the results of the two independent clinical trials and focuses on the more favorable outcome the Bayer-funded clinical test, which suggested the risks of Yaz were similar to those of traditional birth control therapies.

As the top selling oral contraceptive in the world, Yaz is big business for Bayer. The drug brought in $1.86 billion just in the first quarter of 2009.

SOURCE: Yaz Lawsuit › Switzerland investigates the death of young Yaz user

The New York Times recently published a report about the dangers frequently associated with Yaz and other oral contraceptives. The article observes that one Bayer-sponsored European study involving tens of thousands of women found no difference in the level of cardiovascular problems or death between women taking Yaz and women who took levonorgestrel, a much older progestin-based drug.

However, the results of two other studies conducted in Denmark and the Netherlands and published in the British Medical Journal last month, showed that women who took Yaz and other newer progestins had a higher risk of blood clots, which can adversely affect the heart.

One doctor quoted in the New York Times report theorized that Yaz and other newer forms of birth control may have a different affect in European populations versus the more racially diverse and genetically mixed American population.

However, Dr. Frits Rosendaal, a clinical epidemiologist at Leiden University Medical Center in the Netherlands, told the New York Times that patients taking Yaz should switch to birth control drugs containing levonorgestrel. “Even if the risk of thrombosis is low, why not choose the lowest risk, just in case?” he told the New York Times.

Both Bayer and the FDA are conducting ongoing studies designed to measure the safety risks of Yaz and Yasmin against drugs that do not contain drospirenone.

SOURCE: Yaz Lawsuit › Yaz health risks: better safe than sorry?

Earlier this year, the U.S. Food and Drug Administration sent a letter to Bayer Healthcare questioning the company’s ability to handle active pharmaceutical ingredients (API) testing. Bayer acknowledged the FDA’s concerns in an April response to the agency, but said that it had analyzed all relevant batches using its own testing standards and found that the quality of the U.S.-bound drugs was unaffected. Bayer stood by its quality control methods publicly as well.

Last month, the FDA sent another letter to Bayer, warning the company about “significant deviations” in its testing of key Yaz ingredients. “Your firm concluded that these … results were within the accepted variation of the analytical method and that the quality of these batches was not affected,” the FDA letter stated. “We disagree with your rationale and conclusion. An assay test is used to determine potency, not method variability.”

Rose Talarico, a spokeswoman for Bayer, told Reuters that the company was preparing a response to the FDA. “Based on our assessment at this point in time, we have identified no safety and efficacy impact on our products in relation to the [good manufacturing practice] issues as cited by the FDA,” she said.

The FDA warning to Bayer concerning its API testing wasn’t the first time the agency has found the company in violation of federal regulations. Last October, the FDA cited Bayer for false and misleading television advertisements that promoted Yaz for conditions for which it wasn’t approved, exaggerated its effectiveness, and downplayed the risks associated with the drug. FDA pressure prompted Bayer to launch another American ad campaign correcting the misrepresentations of the earlier ads.

Michael A. Santoro, an associate professor of ethics at the Rutgers Business School who studies pharmaceutical industry ethics, told the New York Times that the FDA warnings about quality control and advertising raise a red flag about Bayer’s attitude in complying with federal regulations. Santoro said that drug manufacturers ought to set higher standards for themselves than those established by the federal government.

“It tells me that [Bayer] is not understanding the business that it is in, that it is not understanding the health risks that it is posing to the public or the financial risk that it is creating for its shareholders,” Santoro told the New York Times.

His concerns seems to be bolstered by the growing number of Yaz lawsuits filed against Bayer in the U.S., which currently stand at 74. Some of the lawsuits have been filed by women allegedly harmed by Yaz who claim they were drawn to the drug because of Bayer’s misleading direct-to-consumer television ads.

SOURCE: Yaz Lawsuit › Yaz testing and marketing raises ethical red flag

All of the lawsuits allege that Yaz and Yasmin caused adverse events attributable to the ingredient drospirenone (DRSP), which has been linked to blood clots, strokes, heart attacks, gall bladder disease, deep vein thrombosis, pulmonary embolism, and other serious reactions, including sudden death. The suits assert that Bayer knew about the risks but failed to disclose them to consumers while at the same time aggressively marketing the drug.

Last year, the U.S. Food and Drug Administration warned Bayer that its television advertisements for Yaz were misleading and failed to disclose all of the drug’s risks.

Traditional birth control drugs do not contain DRSP, which is a new type of progestin that influences the body’s natural ability to balance salt and water, which could adversely lead to elevated potassium levels. Excessive potassium levels in the body may trigger fatal cardiac arrhythmia and other serious health problems.

The FDA received more than 50 reports of deaths linked to Yaz and Yasmin between 2004 and 2008. The fatalities involved heart attacks, pulmonary embolisms, and strokes. Excessive blood potassium levels were found in many of the cases.

A U.S. Judicial Panel on Multidistrict Litigation has scheduled a hearing for September 24 to decide if the Yaz and Yasmin lawsuits currently pending in federal courts are similar enough to be consolidated into an MDL (multi-district litigation).

SOURCE: Yaz Lawsuit › Yaz lawsuits consolidated in Pennsylvania

The “deviations,” as the FDA called them, were cited in a letter dated September 9th and sent to Dr. Franz-Josef Renneke, the Site Manager of Bayer’s plant in Bergkamen, Germany. The FDA published the letter on its website this week.

The FDA found that Bayer tested the quality of some drug ingredients, including drospirenone, a main ingredient in Yaz, using a method the U.S. does not accept. The method involves averaging a group of several samples, rather than providing test results for each ingredient batch. The U.S. requires foreign pharmaceutical manufacturers to conform to American standards when testing the quality of its U.S.-bound exports.

Earlier this year, the FDA warned Bayer that it exported ingredients to the U.S. between 2007 and 2009 yet failed to test them using U.S.-approved methods. Bayer responded in April that it had analyzed all relevant batches and concluded that their quality “was not affected.”

That’s beside the point, the FDA’s letter last week said.

“Your firm concluded that these … results were within the accepted variation of the analytical method and that the quality of these batches was not affected,” the FDA letter stated. “We disagree with your rationale and conclusion. An assay test is used to determine potency, not method variability.”

Yaz and Yasmin were Bayer HealthCare’s best-selling drugs last year, with sales reaching $1.8 billion worldwide.

The FDA has not discovered quality problems in the German imports and does not advise consumers taking Yaz to stop. The FDA’s warning is meant to prevent quality problems from occurring in the future.

According to the Associated Press, “The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing and marketing. The letters are not legally binding, but the agency can take companies to court if they are ignored.”

SOURCE: Yaz Lawsuit › Yaz ingredient not properly tested, FDA warns Bayer