Male contraception

Researchers from the University of North Carolina at Chapel Hill found that zapping the testicles of rats with ultrasound machines like the ones physical therapists use to treat muscle injuries, did away with sperm-producing cells. The most effective dosage was determined to be two 15-minute zap sessions, which sent rat sperm counts far below the range considered normal in fertile rats in just two week’s time.

While the test shows promise for an inexpensive, reliable and reversible birth control option, more research will be needed, of course, before the testicle zap test could be available for human men. But it does offer promise for a safer alternative for birth control, especially at a time when the safety of contraceptives are falling under closer review.

Birth control pills are by far the most popular form of hormone contraception, but they carry a remote risk for developing blood clots. Newer generations of birth control pills over the years have lowered that risk, but one of the latest varieties, those that contain the hormone drospirenone, have been shown in recent studies to put women at even greater risk for developing dangerous blood clots.

Pills that contain drospirenone include some of the top- selling brands such as Yaz and Yasmin.

Last month, a Food and Drug Administration (FDA) advisory panel fell short of recommending the pills be banned, opting instead to advise that stronger warnings be placed on the pills’ packages.

Source: ABC News

SOURCE: Yaz Lawsuit › Experimental contraceptive zaps sperm count in rats

Late last year, FDA advisory committees reviewed studies which suggested that birth control pills containing the hormone drospirenone put women at greater risk for blood clots than pills made with older-generation hormones. Blood clots are serious health problems because they can break loose and travel to the heart, lungs or brain causing serious complications or death.

Oral contraceptives that contain drospirenone are the top selling Yaz and Yasmin, as well as Safyral, Beyaz (all made by Bayer) and generics Gianvi, Loryna, Ocella, Syeda, and Zarah.

These claims have resulted in thousands of lawsuits against Bayer by women who say they were not adequately warned that using drospirenone-containing pills could put their life at risk.

The FDA committee fell short of recommending that the pills be banned, instead advising that stronger labels be placed on the pills.

The committee also recommended that stronger warnings be placed on the Ortho Evra birth control patch, made by Johnson & Johnson. Studies have linked the patch to high numbers of blood clots.

While many otherwise healthy women have suffered health problems as result of these contraceptives, experts say women with specific risk factors should probably avoid them altogether. This includes women with blood clotting disorders or a family history of blood clotting, smokers, and women over the age of 35.

Perhaps the best advice is to consider alternatives to birth control pills and patches. Options include the hormone shots and the increasingly popular intrauterine devices (IUDs), which are made in both hormone and non-hormone forms. And there are always more traditional methods, such as condoms, contraceptives sponges and diaphragms.

Source: Everyday Health

SOURCE: Yaz Lawsuit › Women should be aware of blood clot risk with birth control pills, patches

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

It’s time women put the burden of contraception on the men.

A team of Indian scientists is working to do just that – develop a birth control method for men. This experimental contraceptive is reversible and far less invasive than a vasectomy. It works by inhibiting sperm with a tiny electrically charged polymer inserted into a man’s testicles. When negatively charged sperm pass by the polymer, their cell membranes rupture and the tails are damaged. This cripples the sperm and leaves them unable to fertilize. The device reportedly does not inhibit libido nor does it diminish sperm count.

The device is still in the testing phases and effectiveness is still being determined. Researchers will also have to gauge whether the device is linked to any unwanted pregnancies or birth defects. At the very least, it offers a new alternative for men who are willing to step up and take responsibility for quelling unwanted pregnancies.

SOURCE: Yaz Lawsuit › Scientists working on birth control device for men

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

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’?

“My first symptoms were that my back was hurting,” Gina told WISH-TV. Her doctor diagnosed her with pneumonia. After treatment, she started running again, but she just couldn’t seem to get her stride back. “I was fatigued and short of breath,” she said. “I just didn’t feel like myself.”

Not long after that, Gina’s back pain came back and this time was so severe she was hospitalized. That’s when doctors discovered that Gina’s pain was caused by multiple pulmonary embolisms, or blood clots in her lungs.

How could such a young, healthy woman become so seriously ill? Doctors told Gina that her blood clots were likely caused by her birth control pills. Yaz, Gina soon discovered, had caused numerous women of all ages to suffer serious side effects from pulmonary embolism and deep vein thrombosis, to heart attack and stroke. Some women also reported gallbladder problems.

More than 2,000 women who became ill while taking Yaz and Bayer’s sister contraceptive, Yasmin, have filed suit against the drug maker claiming they were not adequately warned that taking Yaz or Yasmin could cause them serious illness and even sudden death.

Gina has filed a lawsuit against Bayer and is telling her story to warn other women of the dangers of Yaz and Yasmin. “I will be completely fine,” she said. “But for a lot of women, they weren’t so lucky.”

SOURCE: Yaz Lawsuit › CFO blames Yaz for her life-threatening blood clots

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

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?