FDA Panel: Strengthen Yaz Warnings

 

Last week, an advisory panel of the FDA met to hear testimony about the safety of these drugs.  After hours of debate, the panel voted 15-11 to allow the drug to stay on the market.  That certainly has to cause great concern to Bayer, the manufacturer.  Some of those who voted in favor of the drugs nevertheless had serious concern about the risks.  

 

Bayer spent much of their time in the hearing attempting to discredit seven studies which show potential problems with the safety of the drugs.  One of the studies sponsored by the FDA found a doubling of the risk of blood clots for patients taking Bayer's pills compared to other similar medications.  As a result, the panel voted 21-5 in favor of strengthening the warnings on the labels of the drugs.  Several on the panel pointed out the fact that the studies relied on by Bayer in arguing the safety of their products were paid for by, you guessed it, Bayer.  Funny how that seems to crop up in many of these cases.  And the drug manufacturers can do it with a straight face, too.

 

It is expected that the FDA will strengthen the warning on these drugs.  However, the panel's vote is just a recommendation, nothing more.  The FDA has to make the final call.  But even if the warning is made stronger, the drugs will likely stay on the market.  The FDA says it will do more studies on the risks of these drugs, but they have not figured out where the money will come from to pay for them.