March 24, 2012

Concerns About the FDA’s Review of the Safety of Yasmin and Similar Contraceptives

Last December, a joint meeting of the FDA’s Reproductive Health Drugs and Drug Safety and Risk Management advisory committees met to discuss the safety of birth control pills containing drospirenone, such as Yasmin and YAZ (both Bayer products). Concerns have been raised about the increased risk from the drugs of venous thromboembolism – blood clots in the legs or that travel to the lungs, which can be fatal.

The committees were asked to consider, among other things, the conflicting evidence on these risks in reported studies, whether the benefits of using drospirenone-containing drugs for pregnancy prevention outweigh the risks, and whether users of these drugs are at an increased risk of clots (VTE) compared to users of other oral contraceptives.

According to the background documents for the advisory committee meeting, the studies funded by the drug company did not find any difference in the risk of VTE between women taking dropsirenone-containing drugs (Yasmin) compared to women taking other combined oral contraceptives.

The FDA funded a separate study combaring Yasmin to other oral contraceptives, and this study did find an increased risk of VTE with Yasmin, especially in women younger than 35 years old. They explain that because of the different designs of the different studies, and because the different results can’t be reconciled just by looking at these different study designs, “none of the studies to date provides a definitive answer” about the safety of drugs like Yasmin in terms of VTE risks.

The FDA also noted that all of the studies examined focused on Yasmin or its equivalent (3 mg drospirenone and .03 mg estrogen), while none of the studies reviewed by the committees examined YAZ (3mg drospirenone and .02 mg estrogen).

Former OBOS board member Pamela Bridgewater testified at the meeting, urging the committee to consider why “the studies that had the closest ties to Bayer show no evidence of an increase in blood clots.” Cindy Pearson of the National Women’s Health Network also testified, asking the agency to “take these more dangerous and no-more-beneficial products off the market, and get back to the arc of history and progress that protects women while supporting their contraceptive choices.”

While the committee members voted 15 to 11 that the benefits of drugs like Yasmin outweigh their risks, the transcript of the meeting provides illuminating comments they made as they voted. Many of those who voted yes said they believed that the risks of unwanted pregnancy are greater, and that the absolute risk of VTE is small. Others, however, expressed concerns about the conflicting data, and suggested that they’d change their vote to no if the standard was how the drug compared to other types of oral contraceptives. Many of the members voting no also expressed concerns that these drugs may be no better and may be more harmful that other oral contraceptives on the market.

For example, Dr. Jacqueline Gardner explained:

I don’t usually vote against choices, but this time I did. And the reason is because on the benefit side, I didn’t see any improved benefit over the existing available choices; and there are so many of them, I believe that as far as oral contraceptives are concerned, women could find alternatives. I don’t see that the alternative to this product is necessarily unintended pregnancy. That’s not the balance, but rather, other safer alternatives. And I, too, believe that when all of the studies are analyzed adequately, that we may find that the risk is even higher, and that translates to a large number of women, in public health terms.

Our Bodies Ourselves has signed onto a letter to FDA Commissioner Margaret Hamburg expressing concerns about the composition of the panel and the focus on comparison of risks and benefits of these oral contraceptives compared to pregnancy, rather than on whether the risks and benefits of drugs like Yasmin outweigh the risks and benefits compared to other oral contraceptives.

Bayer was previously required by the FDA to run corrective ads because their television commercials for the drug were found by the agency to be “misleading because they broaden the drug’s indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug.” There have also been reports that Bayer previously withheld harms information about Yasmin and blood clots from the FDA.

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