Why the FDA Recalled Bayer's Yaz/Yasmin... and No One Knew
With so many well-known and well-published lawsuits filed against Bayer claiming that the company’s popular drug Yaz/Yasmin demonstrates a higher risk of causing blood clots, you would think that the fact that the drug was recalled in November 2009 would be popular news topic. It isn't. In fact, almost no one knew that the FDA recalled Yaz at all.
The reason why no one knew that the FDA recalled Yaz/Yasmin is simple: Bayer reported that the drug Yaz/Yasmin was within specifications when it wasn't. It changed the numbers of the dosages of drospirenone and ethinyl estradiol in each pill, changing the analytical value so that its reports would ensure the drug met the specifications needed for FDA approval. Get this... No one noticed the change at all.
When the recall was actually issued in November 2009, the results of the recall weren't even listed where they were supposed to be on the FDA website, which at its best can be impossibly difficult to navigate. The recall information was posted in an "Enforcement Report" section of the website, when it was supposed to be listed in the "Recalls, Market Withdrawals, and Safety Alerts" section.
The recall information is important to the lawsuits for several reasons. First of all, the recall involved the dosage of the drospirenone that was in the pill. This is the main ingredient that the claimants in the suit say makes Yaz/Yasmin more dangerous than the original recipe for the drug. Secondly, the recall was actually a massive one. The FDA recalled 32,856 boxes of Yaz/Yasmin, with each box containing 3 packs in it. It also recalled 122,208 boxes of Ocella, an identical copy of Yaz.
The last reason is the most important detail of the recall. While the recall was officially dated by Bayer as taking place on November 29, 2009, the FDA actually inspected them in March 2009 where Bayer was warned against rearranging their averages again in August 2009.
The public isn’t the only ones left in the dark about the recall.
"Even the lawyers that were suing Bayer didn't know about it," Janet G. Abaray told BNET. I'll bet that this was just the kind of news that the lawyers needed.
