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

The FDA panel was charged with reviewing studies that showed a newer generation of birth control pills containing the hormone drospirenone put women at greater risk for life threatening blood clots than other oral contraceptives with other hormones. Drospirenone-containing pills include Yaz and Yasmin, made by Bayer. The drug company also sells versions of the pills containing folic acid under the brand names Beyaz and Safyral. Generic versions are also available.

While all birth control pills carry a risk for blood clots, new studies have shown drospirenone-containing pills to be more dangerous. Blood clots are a serious and potentially deadly medical condition. If the clots break free, they can travel to the heart and cause heart attack, travel to the brain and cause stroke, or travel to the lungs and cause pulmonary embolism.

The FDA ordered a review of the pills based on these new studies. The panel fell short of recommending banning the pills, opting instead to put stronger warnings on the drug’s safety label.

Following the vote, POGO (Project on Government Oversight) discovered that three of the panel’s advisers had research or financial ties to Bayer. A fourth adviser had a connection to Teva Pharmaceuticals, maker of generic versions of the pills. All four of those advisers voted to keep the drugs on the market, noting that the benefits of the pills outweighed the risks.

“The American public must be able to trust that the FDA and its advisory committees are making decisions based on science, not industry influence,” POGO Executive Director Danielle Brian told Huffington Post. The organization argues that a revote on the panel’s recommendation is in the best interest of the consumer.

Source: Huffington Post

SOURCE: Yaz Lawsuit › Watchdog group pushes FDA panel to revote on Yaz safety

The order held at bay nine “bellwether trials” that would have paved the way for the mass settlement of more than 10,000 lawsuits against Bayer for its top selling birth control pills, Yaz and Yasmin. The lawsuits accuse Bayer of misleading women about the safety risks associated with its oral contraceptives.

Yaz and Yasmin are a newer generation of birth control pills that contain the hormone drospirenone. Since the drugs were introduced to the market, generic brands and other formulations of birth control pills containing drospirenone have entered the market.

All birth control pills carry a slight risk for blood clots, but new studies suggest that the risk is even greater with birth control pills that contain drospirenone. A Food and Drug Administration (FDA) expert panel recently reviewed the studies and recommended that the pills’ labels carry stronger warnings about the blood clot risk.

Yaz and Yasmin became the top selling birth control pills in the United States with a staggering $1.58 billion in sales in 2010.

Source: The Madison St. Clair Record

SOURCE: Yaz Lawsuit › First Yaz trial will be April 30 if mediation fails

The Project on Government Oversight (POGO), a non-partisan, non-profit government advocacy group, found that of the 26 advisers on the FDA panel, three had research or financial ties to Bayer, makers of the top selling oral contraceptives Yaz and Yasmin. All four of those panel members voted in favor of keeping drospirenone-containing pills on the market.

Drospirenone is a hormone that works like a diuretic. It is found in Yaz and Yasmin, as well as various generic brands. The drugs came under FDA review after recent studies that suggested the pills were more likely to cause blood clots than birth control pills made with other hormones.

This week, POGO sent a letter to the FDA asking for the pills to be reviewed again, this time by a new, better vetted, advisory panel. “The American public must be able to trust that the FDA and its advisory committees are making decisions based on science, not industry influence,” POGO Executive Director Danielle Brian said.

FDA advisory panels review studies and make recommendations to the federal agency. While the FDA generally follows the advice of its exert panels, it is not required to do so.

Source: MedPageToday

SOURCE: Yaz Lawsuit › FDA panel members had ties to Yaz maker

U.S. District Judge David Herndon ordered Bayer and lawyers for the defendant to meet with mediator Stephen Saltzburg, a Gerorge Washington University law professor, to explore a possible settlement.

Yaz and Yasmin are a newer generation of birth control pills that contain the hormone drospirenone. New studies have indicated that the pills may put women at greater risk for suffering blood clots than pills with older hormones. An advisory committee to the Food and Drug Administration (FDA) last month recommended that stronger warnings about the greater risk of blood clots be added to the drugs’ safety labels.

Blood clots are potentially life-threatening conditions. They can break free and travel through the bloodstream and lodge in the heart and cause heart attacks, in the brain and trigger a stroke, or in the lungs which can cause a pulmonary embolism. Thousands of women allege that Bayer did not adequately warn them that taking Yaz or Yasmin could be deadly.

Yaz and Yasmin became the top selling birth control pill in the United States, with $1.58 billion in sales in 2010 alone. Bayer issued a statement saying that while it continues to defend the litigation, the company is engaged in mediation and settlement discussion.

Source: Business Week

SOURCE: Yaz Lawsuit › First Yaz lawsuit ordered to mediation for potential settlement

It is already understood that a history of breast cancer in mothers, sisters and grandmothers increases the likelihood that a woman will develop breast cancer. Statistically, these women are nearly 300 percent more likely to develop the disease compared to women with no history of breast cancer.

The new study, conducted by R. Lodha and colleagues in LM Medical Collage and Research Centre in Bhopal, India, is based on data collected from central Indian women from October 2008 through August 2009. Researchers found that women who had a history of using oral contraceptives were 200 percent more likely to develop breast cancer compared to women who did not use birth control pills. They also found that women who never breastfed were 262 percent more likely to develop the disease.

“The findings of the present study suggests that positive family history of breast cancer and history of using (birth control pills) may be the epigenetic factors promoting the occurrence of breast cancer, while breast feeding reduces the possibility of acquiring breast cancer,” the researchers concluded.

The study contradicts other studies that suggest using birth control pills lowers women’s chances of developing cancer of the breast, ovaries or uterus.

A woman’s choice to use birth control pills – and which types of oral contraceptives – should be based on weighing the potential risks against the potential benefits. Using any type of birth control pill increases a woman’s risk for dangerous blood clots.

Newer studies show that a woman is at even greater risk with newer generation birth control pills that contain the hormone drospirenone. These pills include the top selling brands Yaz and Yasmin, as well as their generic equivalents.

Source: Food Consumer

SOURCE: Yaz Lawsuit › No breastfeeding plus birth control pills may increase risk of breast cancer

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

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?

The study, released last month, puts the blood clot risk with drospirenone-containing pills at 43 to 65 percent greater when compared to pills with other types of hormones. The latest study is based on data from 330,000 Israeli women.

Previous research, involving 835,826 women ranging in age from 10 to 55 who were taking pills like Yaz, suggested the blood clot risk was as much as 74 percent greater with drospirenone pills compared to oral contraceptives containing older hormones.

All birth control pills carry a risk for blood clots, but the latest study provides more evidence that pills like Bayer’s Yaz and Yasmin may be even more dangerous. Blood clots can lead to serious complications such as strokes, heart attacks and even death. The pills have also been associated with gallbladder damage.

Other pills that contain drospirenone include Bayer’s Beyaz and Safyral. There are also numerous generic versions available.

Tens of thousands of lawsuits have been filed by women who say they have suffered serious injuries from the pills, and who say Bayer did not adequately warn them that using the pills could put their lives at risk.

A Food and Drug Administration (FDA) advisory committee recently recommended that stronger warnings be placed on the packages of oral contraceptives containing drospirenone.

Source: Beasley Allen Personal Injury Attorney

SOURCE: Yaz Lawsuit › New studies show increased risk of blood clots with Yaz

Yaz

Watson wants to take a bite out of the $173 million in sales Yaz has generated for the 12 months ended on September 30. The drug company is currently in a patent dispute with Bayer regarding Yaz.

Vestura joins others in this newer formulation of oral contraceptives that contain the hormone drospirenine. Others in this class include Yaz, Yasmin, Beyaz and Safyral.

An FDA advisory panel recently reviewed studies on the safety of drospirenone-containing pills that showed the pills appear to put users at greater risk for blood clots, heart attacks, strokes and even death. The pills have also been associated with gallbladder damage. The committee ultimately recommended stronger warnings be placed on the drugs’ packages. The FDA is not required to follow the advice of its advisory panels, but it usually does.

Bayer is currently embroiled in thousands of lawsuits over its family of drospirenone-containing pills from women who claim the drug company knew the drugs were dangerous but continued to sell them.

Source: WSJ

SOURCE: Yaz Lawsuit › FDA approves generic Yaz despite serious blood clot warnings

Sid Wolfe

The FDA cited “intellectual conflict of interest” when it pulled Wolfe’s voting power from the agency’s Drug Safety and Risk Management Advisory Committee. Public Citizen has previously warned women to avoid the pills because of the risk for life threatening complications.

The committee was reviewing a new study that suggested drospirenone-containing birth control pills put women at greater risk for blood clots than oral contraceptives with older hormones. Bayer, makers of Yaz and Yasmin, has continually argued that its pills are no more dangerous than other birth control pills.

Bayer is being sued by thousands of women who claim to have suffered injuries, or the families of those who they claim died as a result of taking Yaz and Yasmin. Blood clots can lead to serious complications including strokes, heart attacks and death. The pills have also been linked to gallbladder damage.

The panel ultimately recommended that stronger warnings about the risk of blood clots be placed on the birth control pills. The FDA is not required to follow the recommendations of its advisory panels, but it usually does.

Source: All Gov

SOURCE: Yaz Lawsuit › FDA panel member stripped of voting rights in Yaz-blood clot safety review

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

By all accounts, Tania, who was studying to be a teacher, was the picture of health. She is now a statistic – a piece of data culled from research studies into the safety of birth control pills, like Yasmin, that contain the hormone drospirenone.

Yasmin is one of a family of birth control pills sold by Bayer. Other oral contraceptives that contain drospirenone include Yaz, Beyaz, and Safyral. The family of pills was Bayer’s top selling drug in 2010.

All birth control pills carry a slight risk for blood clots, but a new study suggests that pills that contain drospirenone may put women at even greater risk. The news has led the Food and Drug Administration (FDA) and Health Canada to undergo a safety review on the pills.

The study is based on about 300,000 women in the United Kingdom. Researchers found that women who were taking pills containing drospirenone were at about three times greater risk of developing blood clots in the lungs or legs than women taking oral contraceptives with an older hormone. Blood clots can cause heart attacks, strokes, and sudden death.

Bayer refuses to admit that its pills are more dangerous than others. The drug company also says its safety labeling includes a warning for blood clots. Genevieve finds this warning inadequate. “In the packet for Yasmin there’s a little booklet and it has 35 pages and on page 19 it lists the major side effects. I don’t believe Tania read it and I certainly didn’t. Because the pill is so widely accepted, you just don’t think that something might happen.”

Source: ABC

SOURCE: Yaz Lawsuit › Yasmin birth control pills claim another young life

The Yasmin family of birth control pills include Yaz, Beyaz and Safyral. All of these “four sisters” of contraceptives contain a combination of the hormones drospirenone and ethinyl estradiol. The pills have come under fire in recent weeks after the Food and Drug Administration (FDA) announced that it was reviewing studies that linked drospirenone-containing pills to a greater risk for blood clots. Blood clots can cause heart attacks, strokes, pulmonary embolism, and even sudden death.

Following the announcement Friday that the European Patent Market had pulled the patent on Yasmin, Bayer released a statement: “A decision on possible next steps will be taken by the company after studying the reasons for the decision.”

While the patent revocation begins immediately, there is no word yet how soon competitors will seek to put copycat versions on the market.

Despite competition and bad press about Yaz and Yasmin lawsuits filed on behalf of women who have been injured by the pills, the drug company reported global annual sales of $1.1 billion in 2010.

Source: Reuters

SOURCE: Yaz Lawsuit › Bayer loses European patent for Yasmin

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

Drospirenone is a hormone that works like a diuretic. It is used in combination with another hormone, ethinyl estradiol, in Bayer HealthCare’s Yaz and Yasmin. Bayer recently released Beyaz and Safyral, two more birth control pills identical to Yaz and Yasmin, respectively, but with added folate. There are also generic versions of Yaz and Yasmin available, such as Ocella.

Diuretics can cause significant problems with the gallbladder that in some cases can lead to gallbladder removal. Some studies suggest that drospirenone can also increase potassium levels in the blood and lead to hyperkalemia, a condition which causes heart rhythm disturbances that can cause blood clots and lead to sudden cardiac death, heart attacks, or strokes.

Bayer has long fought allegations that its popular birth control pills can put women’s lives at risk, but with more than 2,000 lawsuits filed against the company from women who say they were harmed by the pills, Bayer’s defense looks weak.

The new study was funded by the Fonds de la recherché en sante du Quebec, a government-financed research agency, and is in the current issue of the Canadian Medical Association Journal.

SOURCE: Yaz Lawsuit › Yaz, Yasmin puts women at greater risk for gallbladder damage

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?