Safyral Needs to Update Labels
Safyral is a birth control medication that is used by a large number of women in Atlanta. It contains drodpirenone and a supplement designed to increase levels of folate in women. But Safyral, like other birth control medications that contain drodpirenone, is being asked by the FDA to bring its label up to date by including warnings.
In December of 2011, an advisory panel of the FDA considered the safety and value of contraceptives that contain drospirenone. Among the contraceptives that the panel considered were Yasmin, Yaz, Beyaz, and Safyral. This inquiry was the result of concern over the increased risk of blood clotting women who use drospirenone are experiencing.
The advisory panel voted 15 to 11 that the benefits of birth control medications that contain drospirenone, like Safyral, offset the risks linked with its use. However, critics argue that there are older forms of birth control that are safer and just as effective as the newer ones that contain drospirenone.
However, the committee made their decision in spite of the fact that lawyers failed to provide the committee with lawsuits against Bayer that could have clearly shown the link between blood clots and drospirenone use. And that Bayer did not inform the FDA of all the cases of blood clots associated with drospirenone before it gained the FDA’s approval.
And the FDA is expected to make a determination on drospirenone birth control medications in future months. The advisory committee only advises the FDA on such matters. It is the FDA that chooses whether or not to follow the committee’s proposals.