11 Of The 26 FDA Panel Members Voted There Were No Sufficient Unique Benefits For YAZ / Yasmin That Cannot Be Found In Other Hormonal Contraceptives
(Posted by Tom Lamb at DrugInjuryWatch.com)
On December 8, 2011 the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a joint meeting to discuss YAZ and Yasmin as well as several other relatively new birth control pills.
In more detail, from the Summary Minutes of this YAZ / Yasmin December 2011 FDA meeting:
Issues: The committees discussed the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel. Drospirenone-containing oral contraceptives for the primary indication of pregnancy prevention include: YASMIN, YAZ (drospirenone/ethinyl estradiol tablets), BEYAZ, SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), Bayer HealthCare, and the generic equivalents for these products.
Of most interest to many observers is the following information for Item #4 of the Questions to the Committee, which we get from the Minutes:
VOTE: Do you believe that, in the general population of women who desire contraception, the benefits of the DRSP-containing oral contraceptives for prevention of pregnancy outweigh their risks?
a. If not, are there subpopulations of women for whom the risk/benefit profile would be favorable?
Yes: 15 No: 11 Abstain: 0
Overall summary comments from those who voted “Yes” included:
a. The small elevation in risk is outweighed by the risk of pregnancy.
b. The data was not sufficient in regards to defining the risk.
c. The committee expressed concern with decreasing availability of a contraceptive that provides effective prevention of pregnancy.
Overall summary comments from those who voted “No” included:
a. There are not sufficient unique benefits for DRSP-containing OCPs that cannot be provided by other hormonal contraceptives.
YAZ / Yasmin / Ocella / Beyaz / Safyral
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For more information about this critical vote and what else went on during the full-day long December 2011 FDA YAZ / Yasmin meeting, see: "Transcript for the December 8, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee" (PDF: 440 pages - 762KB).
Of course, in more recent weeks the attention has gone from the voting results to certain advisory panel members whom did the voting:
- POGO Letter: FDA Advisors on Yaz and Yasmin Have Industry Ties (1/11/12, Project on Government Oversight)
- The Yaz Men: Members of FDA panel reviewing the risks of popular Bayer contraceptive had industry ties (1/9/12, The Washington Monthly)
Meanwhile, as regards the federal court YAZ / Yasmin MDL litigation, on December 31, 2011 Judge David Herndon postponed the first bellwether, or test, case trial which was scheduled to start on January 9, 2012 and ordered mediation to explore possible settlement of the MDL lawsuits.
Of course, we will continue to monitor all the various goings-on concerning YAZ, Yasmin, and the several other birth control pills containing dropsirenone (DRSP).
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