Why Are Drospirenone Label Updates Not Specific to Yasmin?

Washington, DCConcern over Yasmin birth control continues to mount—in tandem with Yaz lawsuits—and while Yasmin manufacturer Bayer released a label update to Yasmin late last month, there are those in the industry who wonder why the label change was not specific to Yasmin side effects, but instead covered a wide swath of any contraceptive containing drospirenone (DRSP) and ethinyl estradiol (EE).

Tom Lamb, writing in the industry blog Drug Industry Watch, made the observation that it was just under a year ago that the US Food and Drug Administration (FDA), in concert with Bayer, issued a similar label change to Yaz, a cousin to Yasmin. The label update to Yaz contained four additional sentences to the Warnings and Precautions section related to Thromboembolic disorders (blood clots) and other vascular problems inherent with that specific class of contraceptives.

Lamb thinks there should have been something specific to Yaz side effects. And now, as of February 20, a similar label update has been added to Yasmin together with other birth control products containing DRSP and ethinyl estradiol.

Yasmin and Yaz were introduced to much fanfare a decade ago as a new-age family of oral contraceptives appealing to younger women. There were claims that the duo minimized bloating and water retention, and even helped to clear up skin. Bayer was later admonished by the FDA and made to retract what were thought to be misleading statements in ad campaigns, but the die was cast and the birth control products quickly rose to become top-sellers.

However, much debate has centered on various claims that Yaz and Yasmin carry a higher risk for thromboembolic events (Yasmin blood clots), and various Yaz lawsuits (as well as Yasmin lawsuit) have followed, given alleged injuries and even death associated with the drospirenone and ethinyl estradiol products.

Various studies have suggested that the risk for blood clot associated with Yaz and Yasmin is higher when compared with other, older-generation birth control pills. Other studies have proven inconclusive. Bayer has consistently defended its product, citing its position that Yasmin and Yaz carry no greater risk for blood clot than older, more traditional birth control products.

It should be noted that in December of last year, an expert panel under the auspices of the FDA voted 21 to 5 to bolster labeling for Yasmin and Yaz with regard to blood clots. The label updates appearing last month reference all birth control products containing the synthetic hormone drospirenone and ethinyl estradiol, as opposed to restricting the label change to Yaz side effects specifically and the Yasmin pill.

Yasmin gallbladder problems have also been alleged. On February 28, Bayer announced a near doubling of profits in 2011, and indicated the pharmaceutical giant is "off to a solid start in 2012," according to a published report in Global Insight (2/28/12).