Product News and Recalls

FDA committe recommends monitoring of Beyaz

An advisory committee for the U.S. Food and Drug Administration recommended continued monitoring of Bayer’s birth control pill Beyaz, following a review that made note of serious “adverse events” connected with the pill – including five deaths.

The safety review was focused on Beyaz use for post-pubescent girls who haven’t yet reached adulthood, but included information that applied to both adolescent and adult patients.

Beyaz is approved for use both as birth control, and as acne treatment for females aged 14 and older. It contains the synthetic hormone drospirenone, as do the contraceptives Yasmin, Yaz and Ocella.

All four have been linked to a higher incidence of potentially deadly blood clots. A number of studies indicate that the drospirenone contraceptives increase the risk of clots up to three times compared to other oral contraceptives on the market.

The review notes that Beyaz’s label was recently updated to reflect that increased risk.

Blood clots can be deadly if the clot migrates to the brain, heart or lungs. The review makes note of cases involving teenaged girls who were hospitalized because of conditions related to blood clots.

The review notes that 467 adverse events connected to Beyaz were reported between Sept. 24, 2010, and May 1, 2012. That included 130 ranked as “serious” and five deaths.

Patients should consult their doctors before making any changes in their medication. A consultation with a Beyaz lawyer is also important if there are significant injuries while on Beyaz or similar birth control pills.

See the review here:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM319357.pdf