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Yaz/Yasmin: FDA Reviews Bayer’s Warnings

Several FDA groups met on December 8 to review warnings on Bayer’s five drospirenone-containing birth control pills. This meeting is the product of several months of mounting evidence that these birth control pills are unreasonably dangerous, particularly considering safer alternatives.

First a review: Bayer (through Berlex, a company later enveloped by Bayer) developed and released Yasmin in May 2001. Ocella, manufactured by Barr Laboratories, is the generic of Yasmin. These drugs contain an active progestin ingredient to help prevent ovulation. Many other birth control pills contain the progestin levonorgestrel, but Yasmin and Ocella use the newer (and less tested) “fourth-generation” progestin known as drospirenone.

Yaz was approved by the FDA in 2006, and that’s when the heavy marketing (and sales) really took off. Bayer wasn’t actually printing money, and they didn’t have a printing press in their basement, but this was the closest thing to it. Yaz marketing was calculatingly directed at women’s sense of individuality and freedom. Nefariously, it was also directed to uses not approved by the FDA, including PMS, bloating, muscle fatigue, and aches. Because of the excellent marketing campaign, Yaz and Yasmin profits were $998 million in 2008.

Predictably, the problems then started surfacing: venous thromboembolism (blood clots) and pulmonary embolism, all leading to strokes and heart attacks. There is also a significant number of studies and anecdotal evidence suggesting a link between drospirenone and gallbladder injuries. Many young and healthy women with no other risk factors are having their gallbladders surgically removed. The only commonality is that they all use a member of the Yaz-family of birth control pills.

After the FDA slapped Bayer with an order requiring $20 million in corrective advertising to undo all the damage they had done, Bayer needed something to help its new image problem. The answer? A Hollywood-style reboot of the formerly famous pills: Safyral (Yasmin with vitamin B) and Beyaz (also with vitamin B). These are lackluster attempts to regain market share.

A few days ago the FDA had a meeting. The Reproductive Health Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee met and took a vote. 21 out of 26 members concluded that the risk profile of these drugs was not adequately reflected in package warnings. They noted, however, that the drugs’ benefits may outweigh the risks. In this case, though, it seems it might be a good idea to warn about those risks and let patients and their doctors decide. This was an advisory committee meeting, and the FDA will now have the chance to follow its recommendations and require a new warning (the likely result), or opt to leave the situation alone.