Consider this: The United States is one of only four countries that allow direct-to-consumer advertising. (The others are New Zealand, Bangladesh, and South Korea.) What the public is more apt to see or read about a drug is not breaking news or scientific studies, but rather advertiser-crafted sound bites or celebrity endorsements of medications heavily advertised on television and magazines.

Rather than relying on the guidance of a health care professional to determine the best drug for a patient, patients now enter doctor’s offices demanding a prescription for a drug to cure their latest ill.

The strategy is brilliant on the pharmaceutical companies’ end. Showcase the many benefits of a particular drug and consumers start asking for it by name – Viagra, Zoloft, Yaz. Suddenly consumers see cures for ailments they never even knew they had.

For example, Bayer, the maker of Yaz, marketed the birth control pill as more than an oral contraceptive. Its ads also focused on the drug’s ability to treat moderate acne and ease the symptoms of PMDD, the more serious form of PMS. Most women know PMS but aren’t aware how the condition differs from PMDD, so Bayer made identifying the condition easy by running ads with “checklists” that consumers could use to track their symptoms against the signs of PMDD.

These “checklists” have become a critical part of pharmaceutical companies’ marketing campaigns, and can be found on drug companies’ websites, on downloadable apps, and in brochures in doctors’ offices. They provide consumers with a powerful tool – the ability to diagnose their own conditions.

Yet, this tactic also provides drug companies with the power to influence patient preferences.

(This “checklist” marketing may explain why Americans spend nearly twice as much per person on prescription drugs than any other developed countries, and we account for nearly half of all sales of prescription drugs worldwide.)

Unfortunately, what these “checklists” often fail to do is point out who are not the best candidates for drugs. Yaz, the drug promoted as the miracle product for acne and PMDD, also carries a warning for blood clots. While all birth control pills carry a risk for this life threatening condition, new studies show that drospirenone, the hormone in Yaz, Yasmin, and some generic birth control pills, may put users at even greater risk for developing blood clots. Blood clots can lead to heart attacks, strokes, and pulmonary embolism, which can lead to death.

Source: New York Times

SOURCE: Yaz Lawsuit › Drug company ‘check lists’ influence patient choice

Combined birth control pills

Combined oral contraceptives contain two hormones – estrogen and progestin. They work by stopping ovulation and by making the lining of the uterus thinner. There are several hormone varieties of combined birth control pills.

The study wasn’t limited to a particular formulation; however, some birth control pills are also approved by the Food and Drug Administration (FDA) to treat acne, such as OrthoTri-cylclen, and another, Yaz, has been approved to treat the symptoms of PMDD, a more severe form of PMS.

The Swedish study on how combined birth control pills affect menstrual pain involved verbal multidimensional scoring, or VMS, during which women would rate their pain as none, mild, moderate, and severe. The study showed that one in three women moved down just one category in pain after taking the pills.

Combined birth control pills have long been believed to relieve pain associated with menstruation, and in some cases have been prescribed solely for the treatment of menstrual cramps, especially young women. But experts warn that the benefits of using birth control pills should be weighed against the risks.

For example, birth control pills carry a risk for life threatening blood clots. Yaz, which is approved for the treatment of PMDD as well as birth control and has become one of the most prescribed oral contraceptives in the country, has been associated with a higher risk for blood clots than older generation pills.

Menstrual pain is a frequently occurring condition affecting a large proportion of young women, but researchers say the study shows only limited evidence that oral contraceptives improve pain.

Sources:
MedPageToday
Arizona Health

SOURCE: Yaz Lawsuit › Combined birth control pills provide limited PMS pain improvement

Confused by her daughter’s sudden illness, Rebecca’s parents ordered an autopsy. The primary cause of death was a blood clot in her heart. “The secondary cause of death was her oral contraceptive,” her mother, April Bapp, told the Barton Chronicle.

Rebecca was taking Ocella, a generic version of the top-selling Yaz birth control pill. The pills are in a newer class of oral contraceptives that contain the hormone drospirenone.

The Food and Drug Administration (FDA) advisory panel recently reviewed studies that indicate the pills put users at greater risk for blood clots than pills containing older hormones, and recommended that stronger warnings be placed on the pills’ packages. Other pills that contain drospirenone include Yasmin, Safyral and Beyaz.

April says her daughter was aware that birth control pills could increase the risk of blood clots, but said both she and her daughter were swayed by the ads for Yaz, which touted the pill for the treatment of PMS and acne. The FDA since ordered Bayer, makers of Yaz, to redo the ads, clearly explaining its approved indications (the drug is approved for the treatment of the more severe PMDD, not PMS) and the risks associated with the pills.

The potential benefits aside, studies have begun to show that the blood clot risk with drospirenone-containing pills is greater than with other types of oral contraceptives. And now Rebecca’s mother April wants to warn others in hopes no more mothers have to experience the same devastating loss she did.

Source: VT Digger

SOURCE: Yaz Lawsuit › Birth control called ‘secondary cause of death’ in young woman taking Yaz

There is no doubt that with all oral contraceptives there is a slight risk for blood clots. Bayer, maker of Yaz and a family of other drospirenone-containing pills such as Yasmin, Beyaz and Safyral, has consistently claimed its pills were no more as dangerous than other birth control pills.

However, newer studies have indicated the risk of drospirenone-containing pills may be as much as 74 percent greater than older generation hormones, such as levonorgestrel.

Blood clots, also known as venous thromboembolism (VTE), can break away and move to the lungs and cause respiratory distress, to the heart and cause heart attacks, or to the brain and trigger strokes – all conditions that can be deadly. The pills have also been associated with a greater risk for gallbladder damage.

Nearly half of the advisory panel charged with reviewing the safety of Yaz voted that the risks associated with the pills were greater than the benefits. But the slight majority of the panel gave credit to the drug’s other so-called benefits, including treating certain menstrual-related problems and moderate acne.

Some voters also raised concerns that the studies did not adequately take into account factors that could contribute to the development of blood clots such as body mass index, smoking, socioeconomic status and family history. The studies were also observational, not controlled.

The committee ultimately voted 21 to 5 that the labels on dropsirenone-containing pills do not adequately reflect the risk-benefit profile and recommended that a stronger warning should be placed on the pills. The FDA is not required to follow the advice of its committee members, but it most often does.

Source: CNN

SOURCE: Yaz Lawsuit › Why would FDA panel not ban Yaz over blood clot risk?

Yaz, made by Bayer, is a newer generation birth control pill that contains the manmade hormone drospirenone, which is designed to mimic the naturally occurring female hormone progesterone. The pill was heavily promoted as an oral contraceptive that could also clear up acne and remedy the bothersome symptoms of premenstrual syndrome. It soon became the nation’s top selling birth control pill.

Bayer has since been fined for making such claims and ordered to run revision ads. Other pills that contain drospirenone include Bayer’s Yasmin, Beyaz and Safyral. Generic varieties are also available.

All birth control pills have a slight risk for blood clots. But recent studies have suggested that the risk of blood clots with drospirenone is higher. Bayer currently faces thousands of lawsuits from women who say they were not adequately warned that using Yaz and pills like it could put them at risk for dangerous blood clots that can lead to stroke, heart attack and death.

The most recent studies convinced the FDA that the safety of drospirenone-containing pills needed a closer look.

Panelists spent more than nine hours discussing the data on blood clot risk with drospirenone pills compared to those with older hormones. While there was discrepancy on the authenticity of the studies, nearly the entire panel voted that the label should clearly state the potential for potentially fatal blood clots.

The fate of Yaz and its similar birth control pills now falls on the FDA. The agency is not required to follow the advice of its panels, but it usually does.

Source: Boston.com

SOURCE: Yaz Lawsuit › FDA panel recommends stricter blood clot warnings on Yaz

The girl was prescribed Yasmin, manufactured by Bayer,  when she was 13 by her dermatologist to help clear up her acne. Her prescription was later changed to the generic Ocella, also manufactured by Bayer but marketed by Teva Pharmaceuticals. Yasmin and Ocella are part of a family of birth control pills that contain the hormone drospirenone. Other brands include Yaz, Yasminella, and Beyaz. Only Yaz and its generic equivalent Gianvi are FDA-approved for the treatment of acne in girls 14 and older.

The lawsuit alleges that Bayer heavily marketed the drugs to appeal to young women by highlighting its pills as a treatment for acne, and by downplaying the serious risks associated with the drugs.

All birth control pills carry a slight risk for blood clots, but recent studies suggest the risk with drospirenone-containing pills is even greater. Blood clots can cause strokes, heart attacks and sudden death. Pills containing drospirenone have also been linked to gallbladder damage.

Bayer faces about 7,000 lawsuits filed on behalf of women who allege they were not adequately warned that taking the pills could seriously injure or kill them.

SOURCE: Yaz Lawsuit › Family of deceased 15-year-old girl files Yasmin lawsuit

Cummins believes it was her daughter’s birth control pills, which she also took for the treatment of acne, that caused her death. She has filed suit against the Bayer Corp., makers of the birth control Yaz, and several of its divisions. The lawsuit was filed as part of a national class-action lawsuit against the makers of Yaz.

The lawsuit states that Bayer “knowingly and falsely represented that Yaz was fit to be used for the purpose for which they were intended, when in fact the drugs were defective and dangerous.” It alleges that Bayer and its partners concealed the dangers of their drugs, neglected to warn the public of those dangers, misrepresented the drugs and violated consumer protection laws.

All birth control pills carry warnings of blood clots on their safety labels, but studies show that the formulation of hormones in Yaz, drospirenone and ethinyl estradiol, puts users at even greater risk for blood clots, which can lead to pulmonary embolism, deep vein thrombosis, heart attack, stroke and sudden death.

Bayer has maintained that its popular oral contraceptive is no more dangerous than other birth control pills, and promises to fight the allegations. “Bayer will defend itself vigorously against these lawsuits,” the company said in a statement.

Source: The Times News

SOURCE: Yaz Lawsuit › Mother files lawsuit against Yaz on behalf of deceased daughter

Bayer

“Given the already large and robust scientific body of evidence, in Bayer’s opinion, these studies do not change the overall assessment about the safety of Bayer’s oral contraceptives,” the company said in a statement.

Yaz and Yasmin are considered “fourth generation” birth control pills and use the hormones ethinyl estradiol and drospirenone. Bayer heavily marketed the pills, even touting Yaz as a cure-all of sorts for bothersome PMS symptoms and acne. The Food and Drug Administration ordered Bayer to rerun the ads, toning down its PMS claims (the drug was approved to also help ease symptoms of the more serious premenstrual dysphoric disorder, PMDD, but not PMS) and specifically outlining the risks associated with the pills, including the risk for life threatening blood clots.

Bayer has since been slapped with lawsuits from women and their families who have suffered from blood clots, heart attacks, strokes, gallbladder damage, and even death after using the pills. Bayer has long argued that Yaz and Yasmin are no more dangerous than other birth control pills.

All oral contraceptives carry a risk for blood clots, and lawsuits have maintained that Bayer’s pills put women at even greater risk. Previous studies that suggested as much were dismissed by Bayer. But two new studies back up plaintiffs’ claims, showing women who took contraceptives with drospirenone had more than twice the risk of developing blood clots than women on a hormone used in older generation pills, levonorgestrel.

Bayer still refuses to accept the blame. According to its statement, “Bayer’s assessment, (of the studies) based on its review to date, is that the manner in which the authors applied the study methodology reported in these two publications show significant flaws and the databases used provide less reliable conclusions than are available from existing scientific evidence around the risk of developing venous thromboembolism (VTE), or blood clots, with combination oral contraceptives (COCs).”

SOURCE: Yaz Lawsuit › Bayer dismisses new studies showing higher blood clot risk with Yaz, Yasmin

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

“My IQ plummeted to 77, borderline mentally retarded,” she told KOCO News. She gradually improved but even now she suffers from chronic pain, has no short-term memory, and cannot drive. She is one of thousands of women across the country who are suing Bayer, the makers of the best-selling birth control pill Yaz, for not properly warning her that taking the pill could cause her serious problems and even death.

If you saw the commercials for Yaz when the pill was first approved for sale in the United States, you would have thought it was designed to solve a host of problems from moodiness and irritability associated with premenstrual syndrome to unsightly acne. The ads worked. In no time Yaz became the best selling oral contraceptive in the United States.

The Food and Drug Administration (FDA) was one of the first to see through the façade. The pill was approved for the treatment of premenstrual dysphoric disorder, also known as PMDD, a far more severe condition than PMS. The ads also used vivid imagery to distract viewers while the drug’s side effects were read. The FDA ordered Bayer to rerun a series of ads, this time clearly stating what the drugs were approved for and clarifying associated risks.

Despite the ads, Bayer contends that its pills are just as safe as other birth control pills. Yet, Yaz is different from most in that it contains a diuretic, which can cause an imbalance in the body that can lead to blood clots, strokes, heart attacks and even gallbladder problems. As the lawsuits continue to mount against Bayer, it is likely the end is nowhere in sight. Some legal experts expect as many as 20,000 to 30,000 complaints from women who have been harmed by Yaz.

SOURCE: Yaz Lawsuit › Lawsuits continue to mount against makers of Yaz

For the next three years, Katie took Yaz, but by the time she was ready to enter college, something changed. She felt constantly sick and spent much of her time in bed. “I didn’t go out. I didn’t see friends. I just laid in bed for the most part, and I was sick all the time,” she told KOKO News. “Eventually, I was vomiting bile.”

Doctors were baffled why such a healthy girl would turn so sick. They soon pinpointed the problem. Katie’s gallbladder was damaged. “I found out that my gallbladder function was at about 64 percent, and it should be between 98 and 100 percent,” she said. She was taken off Yaz and underwent surgery to remove her gallbladder.

Katie is one of thousands of women who are suing Bayer, makers of Yaz. They claim that the drug company was aware its top-selling pill was dangerous but failed to adequately warn women or their doctors of the risks. Bayer contends that Yaz carries the same risks as other oral contraceptives.

Just as the ads claimed, Yaz is different than other pills. It contains a diuretic that doctors say can raise potassium levels in the blood. This can cause the gallbladder to malfunction as well as cause blood clots that increase the risk of other serious problems such as heart attack and stroke.

As for those ads that sold women, like Katie, on the benefits of Yaz? Not long after they started running, the Food and Drug Administration (FDA) penalized Bayer, arguing that the ads for Yaz overstated the drug’s benefits and downplayed the risks. The company was ordered to run a series of ads clarifying its approved uses and clearly stating the risks, which include blood clots, heart attacks, strokes and gallbladder damage.

SOURCE: Yaz Lawsuit › Yaz likely cause of girl’s damaged gallbladder

But folic acid also offered other benefits, some experts claimed. Since folic acid lowers blood levels of the protein homocystine, which is linked to heart and blood vessel disease and other medical problems, some scientists suggested that the B vitamin could also lower the risk of heart disease, stroke or cancer.

However,  a new study published in the Oct. 11 issue of the Archives of Internal Medicine shows that even taken at high doses, folic acid supplements do not improve one’s risk of getting heart disease, a stroke or cancer.

To further complicate matters for Beyaz, the pill contains the same active ingredients as its sister product, Yaz – a hormone and a diuretic. Thus, Beyaz, like Yaz, is indicated not only for pregnancy prevention but also for the treatment of premenstrual dysphoric disorder (PMDD) and moderate acne. It also carries the same health risks, according to clinical studies conducted by Bayer.

Bayer contends that Yaz is no more harmful to women than other birth control pills, which carry a risk of life threatening blood clots. But more than 2,000 lawsuits by women who were seriously injured by Yaz beg to differ.

B vitamin-fortified or not, is Beyaz really a safe choice for women?

SOURCE: Yaz Lawsuit › New birth control pill contains folic acid, but is the B vitamin ‘all that’?

Yasmin and Yaz generate nearly $2 billion each year for Bayer, making the oral contraceptives the largest source of income for the drug company. The drugs contain a special formulation of hormones plus drospirenone, a diuretic, and were heavily marketed following FDA approval for not only preventing pregnancies but also relieving the severe emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) and treating moderate acne.

As sales for the birth control pills exploded in the United States, reports began surfacing of serious side effects associated with the drugs, including heart attacks, strokes, blood clots and even gallbladder problems. Lawsuits followed, alleging the drug company was aware the pills put women at greater risk of life threatening health problems but failed to adequately warn consumers. Bayer claims its pills are no more dangerous than other birth control pills. More than 2,000 lawsuits have been filed against Yaz and Yasmin.

Earlier this month, the FDA approved Watson’s oral contraceptive Zarah, a generic version of Yasmin. Bayer also launched a variation of Yaz, called Beyaz, from which the company expects to generate an annual income of about $680 million.

SOURCE: Yaz Lawsuit › Bayer continues to fight generic competition of its birth control pills

It’s the same question thousands of woman are asking after suffering serious health problems they say were caused by Yaz and Yasmine birth control pills. The pills are a unique formulation that combine a new hormone called ethinyl estradiol with the diuretic drospirenone. Bayer Healthcare, the company that produces the pills, claimed the formulation not only prevented unwanted pregnancies, but also helped curb symptoms of premenstrual dysphoric disorder (PMDD) and moderate acne.

However, experts say the diuretic causes an increase in potassium levels that can lead to blood clots, which puts women at an increased risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis, and even death. More than 2,000 women have filed suit against Bayer claiming they were not adequately warned that taking Yaz or Yasmin put them at risk for serious and life threatening health problems.

“There are a bunch of people out there (who have fallen ill after taking Yaz),” Mollie writes. “Let’s hope we can find them and make other girls aware just how dangerous Yaz really is.”

SOURCE: Yaz Lawsuit › Yaz blood clot victim hopes to warn others

Acne spurred by hormone changes usually occurs the week before the period and often springs up on the chin. “In that situation, you might prescribe a birth control pill along with their standard regimen,” Dr. Berson told Modern Medicine. Oral contraceptives shouldn’t be looked at as the lone cure-all for acne. “It is something that is given to prevent further breakouts. … You would still give it along with the traditional therapies, whether they are topical or oral.”

But birth control pills are not without risks. “Most of the side effects are due to the estrogen component,” Dr. Berson says, adding that the most common problems associated with the pill include nausea, headaches and breast swelling. But, she adds, “there is still potential for deep vein thrombosis and vascular events.”

Yaz (as well as Yasmin and the generic ocella) is one type of birth control pill that has been singled out for its indication for treating acne as well as taming the symptoms of premenstrual dysphoric disorder (PMDD). Because it has multiple indications, more prescriptions are written for Yaz in the United States than any other birth control pill. But, there have also been more lawsuits filed against Yaz from women who say they suffered serious health problems from the pill, including blood clots, heart attacks, strokes, deep vein thrombosis, pulmonary embolism and even gallbladder problems.

Women who have a history of blood clotting disorders, migraines, high blood pressure, smoking or heart disease should not take oral contraceptives because they are at greater risk for blood clots. But even women who had no prior health problems that would make them a bad candidate for the birth control pills still became ill after taking Yaz.

“You want to make sure that (women) understand the potential risks, such as blood clots,” Dr. Berson says.

SOURCE: Yaz Lawsuit › Should you use the pill to treat acne?

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?

Rebecca Anderson-Hull

How could an otherwise healthy woman suffer from life-threatening blood clots? Her doctors said it was likely caused by her oral contraceptives. Rebecca had been taking Yaz, the country’s most widely used birth control pill, for two years.

“Do you think the company knew,” asked CBS 11’s Ginger Allen.
“Yes,” she replied.
“Do you blame the company?” the reporter asked.
“Yes,” Rebecca replied.

Rebecca is just one of thousands of women across the country who have filed lawsuits against Bayer, the makers of Yaz, also known as Yasmin and by the generic ocella. The lawsuits allege that Bayer was aware that its blockbuster birth control pills put women at greater risk of blood clots that could lead to heart attacks, pulmonary embolisms and strokes but failed to adequately warn them that their lives were at risk.

The lawsuits reflect a concern raised not long after the revolutionary birth control pills were introduced to the market. Bayer launched the pills with a huge advertising campaign touting the drug’s benefits for everything from premenstrual syndrome to acne. The Food and Drug Administration barked back at Bayer saying its ads were misleading, that they overstated the benefits of Yaz and minimized the serious risks associated with the pills. Bayer was fined and was ordered to launch a new ad campaign, this time clearly stating the approved uses for the pills and explaining the risk.

But it was too little, too late for many women, including Rebecca. Now Rebecca, and thousands of other victims of Yaz side effects, are demanding justice.

SOURCE: Yaz Lawsuit › Texas woman says Yaz caused brain damage

Stewart was prescribed Yaz by her gynecologist in September 2007 to treat cramps associated with her period. Yaz is marketed as a contraceptive that also treats premenstrual dysphoric disorder (PMDD), premenstrual syndrome, as well as moderate acne. It also is the only birth control pill to contain ethinyl estradiol and drospirenone, a diuretic.

In June 2008, Stewart began to feel pain in her abdomen and learned that her gallbladder was not functioning properly. Two months later her gallbladder was removed. Stewart took a short break from Yaz until April 2009, when she resumed treatment only to go off of it again when she says the pills made her feel queasy. Severe cramping a few months later led her to go back on Yaz. Within days of resuming treatment, Stewart’s lawsuit claims she began suffering severe depression and suicidal thoughts that led her to attempt suicide on two separate occasions.

Stewart’s lawsuit names Bayer, Bayer HealthCare Pharmaceuticals, Bayer HealthCare AG, Bayer HealthCare LLC, Bayer HealthCare Corporation, Berlex Inc., and Berlex Laboratories Inc. The plaintiff seeks unspecified damages, court costs, and attorney fees.

SOURCE: Yaz Lawsuit › Woman blames Yaz for gallbladder damage, severe depression

When the pills were first introduced in the United States, the commercials said they offered an alternative in oral contraception. Yaz and Yasmin are the only pills that contain drospirenone, a diuretic. The ads cited the pills as a proven treatment for premenstrual dysphoric disorder (PMDD) and as an effective treatment for moderate acne. Just as sales of Yaz and Yasmin began to soar, Bayer was penalized by the Food and Drug Administration (FDA), which argued the company overstated the benefits of their birth control pills and downplayed the risks associated with the drug. Bayer was ordered to run new ads clearly stating the risks.

Now, amid mounting lawsuits and criticism, Bayer is reaching out to consumers again, this time through a new website, www.BayerForWomen.com. “Through ongoing research, Bayer works to bring you innovative contraceptive products. We’re committed to improving your health and well-being and to bringing you the facts about the benefits, as well as the safety risks of birth control, including your own,” the site reads. It also features a video to drive home its point. In the video, blindfolded women touching a rhino trying to guess what it is. “A pipe?” “A brush?” The announcers voice plays: “Having only one point of view on anything can be misleading. So before you come to a conclusion make sure to get the full picture. Especially when it comes to your birth control.”

Bayer calls this latest marketing campaign its “unwavering commitment is to your health and well-being. We want you to have the facts on the safety and risks of your birth control, including our own,” the video continues. But considering the countless stories of women injured by the pills, one has to wonder if Bayer is more committed to protecting women, or to protecting its own image.

SOURCE: Yaz Lawsuit › Bayer launches campaign to educate women about birth control

Despina Papparis

The Papparises are among 800 Canadians taking part in a $15 million class-action lawsuit against Bayer Healthcare, the manufacturer of the popular Yaz and Yasmin birth control pills claiming Bayer did not adequately warn women that taking the pills would put them at greater risk of serious health problems. According to the lawsuit, seven Canadian women and more than 50 American women have died while taking Yaz, Yasmin, or its generic Ocella.

Yaz, Yasmin and Ocella have been touted for benefits beyond just birth control. The pill has been marketed as an effective treatment for moderate acne as well as premenstrual dysphoric disorder (PMDD), a condition of severe emotional and physical premenstrual symptoms. The pills are formulated differently from other birth control pills because they contain drospirenone, a diuretic that can increase the potassium level in blood. This increase in potassium can cause heart rhythm disturbances that can cause blood clots as well as problems with the gallbladder.

Source: Calgary Herald

SOURCE: Yaz Lawsuit › 800 Canadians taking part in lawsuit against Yasmin, Yaz maker

Yaz, also known by the brand name Yasmin and the generic brand Ocella, is Bayer’s top-selling oral contraceptive and one of the most popular choices among women and doctors for birth control. Last year, the company raked in more than a billion dollars from the sale of Yaz. The pill is different from other birth control pills because it contains a diuretic, drospirenone, that can raise the potassium in blood to dangerous levels and cause to blood clots that can lead to sudden cardiac death, pulmonary embolism or strokes.

The lawsuits allege that Bayer didn’t do enough to warn women about the serious health risks to women who take Yaz. Even the Food and Drug Administration (FDA) cracked down on the drug company, saying advertisements for the birth control pill were overstating its benefits and understating the risks involved. Yaz commercials touted added benefits such as treatment for symptoms of premenstrual syndrome and acne. Since the FDA crackdown, Yaz was forced to run a series of ads clarifying the use of Yaz and clearly stating the dangers of taking the drug.

Victims say it’s too little, too late.

Bayer’s 2009 annual report does not specify how many women have died from the drug, but the FDA puts the count as high as 59.

SOURCE: Yaz Lawsuit › Bayer facing more than 1,100 lawsuits from women injured by Yaz

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?