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FDA Issues Blood-Clot Warning for Bayer Birth Control Pills... and Bayer Cheers

By Jim Edwards

Updated on: June 1, 2011 / 12:42 PM EDT / MoneyWatch

The FDA yesterday published a safety alert for Bayer (BAYRY)'s birth control pill Yaz that is unhelpful, at best, for anyone who wants to know if the contraceptive is actually more dangerous than other drugs.

And that's the just the way Bayer likes it. The company has successfully fended off critics of the product since 2003, when it was first alerted that Yaz may carry a risk of lethal blood clots in patients.

The FDA said Yaz carried "a greater risk" of clots than other pills, but that women should not stop taking it. It also said that European authorities have tightened safety warnings on Yaz but that the FDA has not. Finally, Bayer told the media something completely different: That the risk was "comparable." Bayer's statement makes no mention of the fact that the FDA currently believes "this risk is reported to be up to 2 to 3 times greater" that other pills.

Confused? You should be, and that's the point: The longer the FDA takes to complete its review of whether Yaz's active ingredient, drospirenone, carries a greater risk of forming lethal blood lots inside the women who take it, the better it is for Bayer. Reports of blood clots associated with Yaz and similar pills (Yasmin, Gianvi, Loryna, Ocella, Syeda, Zarah, Beyaz and Safyral) first emerged in a British Medical Journal report in 2003. Since then there has been a steady drumbeat of bad news about Yaz, most of it associated with blood clots.

The DrugCite database, which sorts data from the FDA's adverse event database, shows a similar overall rate of reported problems between drospirenone-containing pills such as Yaz and pills that use levonorgestrel, the older (and probably safer) ingredient. But look at the recorded number of instances for blood-clot problems within those numbers:

levonorgestrel: Embolism And Thrombosis: 24
Pulmonary Embolism: 16
drospirenone: Embolism And Thrombosis: 115
Pulmonary Embolism: 108

Here's a potted history of Yaz. Note that Bayer has repeatedly pushed the envelope in its marketing of Yaz:

2001: Yaz and Yasmin approved by the FDA for sale in the U.S.
February 2003: British Medical Journal publishes case reports of blood clots in uses of Yasmin.
July 2003: Bayer (then known as Berlex) is warned by the FDA for overstating the efficacy of Yasmin.
2007: Bayer agrees with the Department of Justice not to use any more deceptive advertising for ay of its products.
2008: Bayer deceptively markets Yaz as a cure for PMS.
February 2009: Yaz agrees to spend $20 million on "corrective" marketing disavowing its PMS campaign.
June 2009: Bayer sued for allegedly not warning that Yaz and Yasmin are more risky than older pills. Attorneys claim that as many as 50 women have died while on Yaz because drospirenone carries a greater risk of blood clots than older drugs.
November 2009: 32,856 mislabeled boxes of Yaz are recalled.
March 2010: Suits against Bayer on Yaz top 1,100.
August 2010: Lawsuits top 2,000.
January 2011: Doctors paid by Bayer write contraceptive prescribing guidelines for the Society of Ob/Gyns of Canada. The guidelines do not suggest there are greater risks with Yaz.
March 2011: British authorities cite Bayer for misleadingly promoting Yaz as an acne cure.
April 2010: FDA issues a "MedWatch Alert" warning of two new studies that suggest Yaz is more dangerous than other pills.
April 2011: Lawsuits top 6,850; Swiss TV reports that as many as 190 women have died while taking the drug.
April 26, 2011: Bayer loses legal attempt in Switzerland to silence TV report that criticized the drug's safety record.
May 31, 2011: FDA warns of "possible increased risk of blood clots" with Yaz; Bayer publishes statement asserting risk is "comparable" to other drugs.

You might think that the FDA's new warning is a defeat for Bayer; surely it sounds the death knell for Yaz and other drospirenone brands. What doctor, after all, would now prescribe them knowing there are safer alternatives that are equally effective? Indeed, sales of Yaz declined 15.7 percent to â‚¬242 million in Q1 2011.
But this is a victory. Sales went down not because anyone was worried about its safety but because generic companies began churning out cheap copies after Yaz lost its patent protection in 2010. That was all Bayer needed: For the FDA to move so slowly that it didn't take any action until after the Yaz patent was gone.

Mission accomplished.

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