Brenda’s story is told far too often these days. She is one of more than 1,100 women suing the drug company alleging claims of serious health problems after taking Yasmin, also known as Yaz. The lawsuits claim Bayer was aware of the increased risk of life-threatening blood clots in women taking Yasmin but they failed to adequately warn consumers of that risk. Some studies have backed up those claims; however, Bayer contends the blood clot risk for Yasmin and Yaz is no greater than other oral contraceptives.

Bayer has a reason to contest the claims made by the defendants. Its popular birth control pills have brought in $1.5 billion since 2009, making Yaz and Yasmin the most popular birth control pills in America and a favorite in Canada and numerous European countries. Yasmin and Yaz are different from other birth control pills because they contain drospirenone, a diuretic, that can increase potassium levels in the blood. This imbalance can trigger heart rhythm disturbances that can cause blood clots that can lead to pulmonary embolism, strokes, or even sudden cardiac death. The pills have also been linked to gallbladder disease.

Source: WPIX

SOURCE: Yaz Lawsuit › ‘Wicked’ understudy suffers stroke, joins lawsuit against Yasmin

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

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

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

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

Dawn Varrechio

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

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

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

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

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

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

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

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

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

Bayer

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

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

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

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

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

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

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

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

Research on the safety of the active ingredients in Yaz and Yasmin has offered mixed results. Some studies found drospirenone to be no more dangerous than other birth control pills, while other tests put the risk of getting blood clots – even in young, healthy women – as high as six times greater.

“There is reason to be concerned, I believe, about both of them [Yaz and Yasmin],” Dr. Sidney Wolfe, founder and director of Public Citizen’s Health Research Group, a nonprofit advocacy organization based in Washington, D.C., told the Los Angeles Times. “When evidence like that comes up, people should pay attention to it.”

Bayer Healthcare response? To keep mum. In statements to the press, Bayer still stands by its oral contraceptives saying they are no more dangerous than other birth control pills.

SOURCE: Yaz Lawsuit › Bayer Healthcare still stands behind safety of Yaz, Yasmin

Bayer HealthCare

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

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

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

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

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

Monica Dakin

The 23-year-old Canadian was prescribed the popular oral contraceptive Yaz last May to treat her ovarian cysts. She believed the low-dose hormone carried fewer side effects than other birth control pills. But soon after starting the medication, she was doubled over with abdominal pain. Dakin was hospitalized six times in the first six months before surgeons finally removed her gallbladder in an emergency procedure.

Yaz, also known by the brand name as Yasmin and the generic version Ocella, was touted by its maker Bayer Healthcare for treating premenstrual dysphoric disorder (PMDD), premenstrual syndrome (PMS), and acne. This new type of contraceptive contains an added ingredient, a diuretic known as drospirenone. Dakin contends the diuretic caused the significant problems with her gallbladder and that she was never warned by Bayer that taking the pill could make her sick.

Dakin is one of hundreds of Canadian women suing Bayer Healthcare claiming they suffered severe adverse effects because of the popular birth control pill. The list of injuries includes everything from gallbladder problems to blood clots and even deaths. The lawsuits claim Yaz is more dangerous than other oral contraceptives and that Bayer knew this but failed to adequately warn consumers.

Dakin told Canadian news site HERE that the medical problems caused by Yaz have “ruined a year of my life.” Due to graduate from college in just a few months, she says she will have to sit out the ceremony because her illness set her too far behind.

SOURCE: Yaz Lawsuit › Canadian woman blames Yaz for year-long illness

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

Vicki Parsons

What Vicki didn’t know was that the Food and Drug Administration had linked more than 50 deaths to the use of Yaz, and that blood clots, stroke and other serious complications had been associated with the contraceptive.

Yaz, also known as Yasmin and the generic Ocella, are the only birth control pill that contains drospirenone, a diuretic. While it helps to flush out excess fluid in the body, it can cause a build up of potassium in the blood, which can cause heart rhythm disturbances that can lead to blood clots that can cause sudden cardiac death, pulmonary embolism or strokes.

Vicki is now one of numerous women who are suing Bayer Pharmaceuticals claiming they were not sufficiently warned by the drug company of the dangers of taking Yaz. Yaz denies the claim. “The company is in the process of gathering information on these cases, but the complaints we have review so far pertain to side effects that are warned about in the labeling of all oral contraceptives,” according to a statement Bayer gave to WERG-TV.

SOURCE: Yaz Lawsuit › Woman says Yaz caused blood clots that nearly killed her

Bayer HealthCare

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

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

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

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

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

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

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

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

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

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

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

Bayer Healthcare Corp.

But a group of 50 women in Indianapolis say Bayer is wrong. They are the latest victims to file lawsuits against the drug company, alleging the new formulation of birth control pills caused heart attacks, strokes, blood clots and other health problems.

Yaz and Yasmin, also known by the generic brand Ocella, is as the company’s ads claim – different than other birth control pills. Bayer’s top-selling contraceptive drugs contain ethinyl estradiol plus drospirenone. Drospirenone is a diuretic, which the lawsuits argue can lead to dangerously high levels of potassium, which can lead to hyperkalema. Hyperkalema is a condition that can cause heart rhythm disturbances, which can trigger blood clots and sudden cardiac death or pulmonary embolism or strokes.

The lawsuits allege that Yaz and Yasmin are more aggressive than other oral contraceptives and have left plaintiffs with blood clots and pulmonary embolisms in their legs and lungs. Many had to have their gallbladders removed. Others suffered strokes.

Yet, Bayer, which reaped more than $600 million in sales in 2008, says it is not at fault. “The complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all oral contraceptives, including ours,” according to a statement from Bayer spokeswoman Rose Talarie.

Sources:
UPI
Fox59
Indy Star

SOURCE: Yaz Lawsuit › Bayer claims no fault in Yaz, Yasmin injuries, deaths

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Bayer Healthcare

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Yaz

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

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

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

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

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

SOURCE: Yaz Lawsuit › Yaz lawsuits consolidated in Pennsylvania

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

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

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

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

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

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

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

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

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

Yaz is a combination birth control pill containing drospirenone and ethinyl estradiol. It is marketed not only as a contraceptive pill, but as a treatment for premenstrual dysphoric disorder (PMDD), a condition with severe emotional and physical premenstrual symptoms, and as an effective treatment for moderate acne.

However, the FDA says the original television commercial implied Yaz could also treat Premenstrual Syndrome (PMS) and that it would keep a woman’s skin clear and/or treat more severe acne. Worse than this, the FDA says the commercials used distracting visuals, numerous scene changes, and competing background music that interfered with the audio presentation of the serious risks associated with the product.

“This is particularly troubling as some of the risks being conveyed are serious, even life-threatening,” the FDA letter states. The overall effect of the distractions adds up to “undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that YAZ is safer than has been demonstrated by substantial evidence or substantial clinical experience.”

As a result of the FDA’s findings, the attorneys general of 27 states joined the federal agency in cracking down on misleading consumer advertising, and Bayer was required to create new ads to more clearly communicate the benefits and risks of its product, at a cost of $20 million.

But don’t feel too sorry for Bayer yet. Yaz is the best-selling oral contraceptive product in the United States, with sales in 2008 topping $600 million.

In the new campaign, a young woman seriously addresses the camera, while reminding viewers that they may have heard of Yaz on previous commercials, but that she’s here because “the FDA wants us to correct a few points in those ads.”

Source: New York Times

SOURCE: Yaz Lawsuit › Bayer creates new ad campaign for Yaz after FDA crackdown