FDA's Role In Approving Yaz and Yasmin Examined

Posted on November 3, 2009 by Kristine Meredith

The legal talk show Lawyer2Lawyer invited Mike Danko and an FDA expLawyer2Lawyer Podcastsert, Professor James T. O'Reilly from the University of Cincinnati College of Law, to discuss Yaz and the Yaz lawsuits.  Mike talked about the lawsuits while Professor O'Reilly provided his insights on what the FDA does and, more importantly, does not do when approving a drug for the market.

Bayer was invited to come on the show but didn't accept.

It is an interesting discussion that can be heard on line.

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Yaz and Yasmin: Drug Company Places Profits over Safety

Posted on October 20, 2009 by Kristine Meredith

The trendy Yaz and Yasmin birth control pills are unlike any others because they contain a new synthetic hormone, drospirenone. Bayer has aggressively marketed the drugs, especially to young Yazwomen, as a cure for everything from acne to pre-menstrual syndrome. Unfortunately, Bayer did not adequately test the drug before bringing it to market, and it now ignores two studies on Dutch and Danish women suggesting that the drugs are more dangerous than other birth control pills that don't contain the synthetic hormone. 

Women who take Yaz or Yasmin have suffered a list of harmful side effects. One of the most common is blood clots. Blood clots may lead to debilitating strokes, pulmonary emboli and heart attacks. Women on Yaz or Yasmin have also been stricken by disease and damage to the gallbladder, liver, and pancreas, among other conditions.

The Food and Drug Administration has now decided that Bayer's television commercials were misleading, because they undersold the risks of the drug while at the same time overstating its benefits. In addition, the consumer protection group Public Citizen warns all women against using either Yaz or Yasmin, and instead suggests sticking to a pill that does not contain drospirenone.

Yaz and Yasmin are no more effective than traditional birth control drugs, but they appear to be more dangerous. Nonetheless, because of Bayer's aggressive and misleading advertising, they are now Bayer's most popular drugs. In fact, the drugs are the most popular birth control pills in the world. Last year alone, Bayer sold $1.8 billion worth of Yaz and Yasmin .

Not surprisingly, with that type of money on the line, Bayer continues to promote the drugs, regardless of their risks.

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FDA Determines Yasmin/Yaz Commercials Misleading

Posted on October 17, 2009 by Kristine Meredith

Beginning in July 2003, the Food and Drug Adminstration warned Bayer (or more accurately, Bayer's predecessor, Berlex Laboratories ) that its television commercials for Yasmin were misleading and should be corrected.  The FDA warned Bayer again in 2008, and again in 2009.  Among Bayer's more serious violations, accorYaz Commercial Screen Shotding to the FDA, was that the commercials minimized the risks associated with Yaz while at the same time overstating its benefits -- especially for conditions such as premenstrual syndrome for which the drug was never approved.  According to the FDA:

These violations are concerning from a public health perspective because they encourage use of YAZ in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with YAZ.

 

FDA Warning Re Yaz

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