- The Boston Globe

12/12/2011 - The newer generation birth control pills, which include Yaz, Yasmin, and Beyaz, may soon be slapped with a new warning label that says the products are more likely to cause blood clots than other forms of oral contraceptives. That’s after an expert panel convened yesterday by the US Food and Drug Administration concluded -- in a 21 to 5 vote -- that the labels currently on these products didn’t adequately reflect the risk of developing blood clots in the legs that could turn life-threatening if they wind up in the lungs.

The agency must now decide in the next few months whether to follow the advice of its advisory committee, which it typically does.

Expressing concern about these products back in September, the agency decided to call on experts to review the latest research and determine whether the products’ benefits outweighed their risks -- the panel determined that they did -- and whether a new warning should be added to the labels.

The pills, which contain the progestin drospirenone, became blockbuster sellers over the past few years because of a blitz of consumer ads extolling benefits -- like treatment for acne and premenstrual depression -- that go beyond birth control. But prescriptions have declined recently with the growing awareness of blood clot risks.

Bayer HealthCare, maker of Yasmin and Yaz, insists there is no added risk and presented several studies at yesterday’s FDA meeting showing that Yasmin users tracked for up to a decade didn’t have a greater incidence of developing clots compared with those who used other forms of oral contraceptives.

But other studies presented by FDA officials found that drospirenone-containing pills do increase a woman’s risk, with some showing a 50 percent increased risk and others finding more than double the risk. All in all, however, the absolute risk is still very small -- less than a fraction of 1 percent of pill users.

The variance in the data could be due to how the studies were designed and whether there were any unaccounted for differences between those women who chose to take a drospirenone-containing pill versus those who took another contraceptive.

At the meeting, John Seeger, a pharmacological researcher at Brigham and Women’s Hospital who helped conduct one of the Bayer-sponsored studies, insisted that there was “very little difference” between how the women were chosen and tracked for the Bayer study compared with research not conducted by the manufacturer.

Perhaps a bigger issue that still remains unknown is whether certain subgroups of women -- like those over 35 or with a family history of blood clots -- would be more likely to develop problems from Yasmin or Yaz than other contraceptives. The advisory committee voted that they didn’t have enough information from any of the studies to reach conclusions on that front.

All in all, though, the risk of getting a blood clot from any type of contraceptive remains small. According to FDA data presented at yesterday’s meeting, about 10 in 10,000 women on Yasmin experience a clot compared with about 7 in 10,000 on older varieties of the pill. Where the blood clot risks increase most dramatically, all experts agree, is for female smokers over age 35 who take any type of birth control pill.

Yaz / Yasmin / Ocella Lawsuit News Archive::

If you or a loved one have suffered serious yaz side effects, injury or death while using Yaz you may be entitled to compensation. Contact the yaz side effects lawyers of Ennis & Ennis, P.A. today for a free nationwide case evaluation. Our experienced Yaz attorneys can answer any questions you may have about Yaz side effects or a potential Yaz lawsuit. Fill out the case evaluation form at ennislaw.com  or call toll free: 1.800.856.6405.

Under no circumstances should you discontinue taking any medication, including Yaz or one the generic versions, without first consulting with your doctor.