Image via WikipediaAfter hours of circular debate about the safety of this family of oral contraceptives, 15 of the FDA's 26 expert advisors voted that the benefits of these birth control pills outweigh the risk of dangerous blood clots.
But that's no tub-thumping victory for Bayer. It created this family of contraceptives, which now includes Beyaz and Safyral. They contain a hormone called drospirenonethat's found in none of the other two dozen or so birth control pills available to American women.
And many who voted in favor of Bayer's drugs expressed serious reservations because of the risks. "I voted yes, but it was a difficult vote," said Sean Hennessy of the University of Pennsylvania. "I think the drug probably ought to be rarely used."
Underscoring those doubts, 21 of the 26 panelists voted for strengthening the warnings on labels of Bayer's contraceptives to reflect the findings of seven studies that the company's team had spent much of the day trying to discredit.
One of the seven was a 835,000-woman study commissioned by the FDA; it found about a two-fold increase in blood clots for Bayer's pills compared to competitors' products.
Nobody's completely satisfied with the quality of the evidence on the safety of Bayer's contraceptives containing drospirenone.
But many pointed out that the studies Bayer relies on most to argue for the drugs' safety were paid for by the company. Bayer makes a bundle on its contraceptives, although U.S. sales have fallen sharply since doubts began to be raised in 2009.
