March 5, 2013

Europe Takes on Review of Birth Control Pills Containing Drospirenone

While most birth control pills currently available in the United States are safe for most women, some newer pills that contain the progestin drospirenone have come under scrutiny because of an increased risk of blood clots. Birth control pills containing drospirenone include Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz and Zarah.

The European Medicines Agency (EMA) announced late last month that it would take another look at so-called third and fourth generation oral contraceptives, including those with drospirenone, and consider whether use of these drugs should be limited.

The agency also plans to review whether current product information is enough to properly inform women and their health care providers of the risks. The agency has also said, though, “There is no reason for any woman to stop taking her contraceptive” — a rather confusing message for women wondering if they should switch to other types of pills.

The EMA previously reviewed whether this type of drug (specifically Yaz) could be marketed for use in preventing acne, but decided it could not based on concerns about the clot risk; it factored in that if women who no longer needed contraception or no longer needed the acne treatment continued on the drug, they would be exposed to unnecessary additional risk.

The U.S. FDA also did a review of pills with drospirenone, and is requiring language about the higher risk of blood clots to be added to the labels. As we noted last year, women’s health experts, including OBOS, have concerns about that review, and about leaving these pills on the market when safer alternatives exist.

That’s a key point in considering pills with drospirenone. While the risk of clots is small, we know the risk is higher with these pills than with other oral contraceptives. As one expert testified before the FDA, “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.”

In the Women’s Health Activist newsletter in spring of 2012, Amy Allina, program and policy director of the National Women’s Health Network, wrote:

The question for a woman is, what should she weigh these risks against? As some have pointed out, the blood clot risks of pregnancy are greater than those of drospirenone pills. Is that the right basis of comparison? The Network does not believe it is. There are other, safer, ways women can avoid the risks of pregnancy – including contraceptive pills that don’t contain drospirenone. Drospirenone pills don’t provide a unique benefit over other available contraceptive pills. We’re also concerned that most women using drospirenone pills are unaware that other contraceptive pills are safer.

The NWHN has asked the FDA to remove these pills from the market. Allina wrote: “We believe that women who are looking for contraceptive options to help them postpone or prevent pregnancy should not be unnecessarily exposed to a higher risk of blood clots when there are safer alternatives with the same benefits available.”


2 Responses to “Europe Takes on Review of Birth Control Pills Containing Drospirenone”

  1. OBGYN in Stark County OH Says:

    Thank you for sharing this. I know many of the doctors I work with are against the contraceptives containing drospirenone simply because of the fact that there are so many other safer alternatives, and I see that seems to be the consensus from your article. I’m glad to see that these drugs are being reviewed. It’s sad when their is no benefit to a drug other than lining the maker’s pocket, yet pharmaceutical companies still try to push it.

  2. Prenatal Expert Says:

    I’ve heard about the increased clotting risk with Yaz specifically; doesn’t surprise me that there’s now a push to remove these contraceptives from the market.

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