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

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

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

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

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

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

Source: Daily Record

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

The gallbladder’s sole function is to store bile, a dark green to yellowish brown fluid produced by the liver to aid in the digestion of fats in the small intestine. When the gallbladder becomes diseased, it can become inflamed and produce gallstones. A gallbladder attack occurs when the stones block the flow of bile. These attacks can cause excruciating pain and oftentimes the only remedy is to have the gallbladder removed.

Common contributing factors include weight gain or loss, hypothyroidism or thyroid disease, high cholesterol, alcohol intake, family history of gallbladder disease, and diabetes. However, use of estrogen and birth control pills are also considered risk factors as estrogen increases the concentration of cholesterol in the bile.

Gallbladder disease is one of the many serious adverse events reported with use of one particular brand of birth control pill, Yaz, also known as Yasmin and Ocela. An estimated 1,100 lawsuits have been filed against Bayer, the makers of Yaz, by women who say the birth control pill caused them to develop gallbladder disease, blood clots, seizures, cardiac arrhythmias, heart attacks, or strokes. As many as 59 deaths to date have been linked to Yaz.

SOURCE: Yaz Lawsuit › Birth control pill Yaz linked to gallbladder disease

“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

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

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

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

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

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

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

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

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

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

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

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

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

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

SOURCE: Yaz Lawsuit › Yaz lawsuits consolidated in Pennsylvania

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

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

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

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

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

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

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

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

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

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