Beyaz Side Effects Yet to Reach the Courts

Washington, DCIn spite of updated recommendations that suggest oral contraceptives containing the synthetic hormone drospirenone carry a "possible minimally increased risk" of blood clots, thousands of lawsuits appear to suggest the risk in real numbers is anything but minimal. As for Beyaz side effects, the drospirenone-containing cousin of Yasmin and Yaz has flown under the radar when compared with its more talked-about Bayer counterparts. But lawyers wonder if it's just a matter of time before the side effects of Beyaz will translate to a hefty presence in the nation's courts.

The Orlando Sentinel (10/26/12) reported new recommendations released by the American College of Obstetricians and Gynecologists (ACOG) that appear to tread carefully. Oral contraceptives containing drospirenone??"of which Beyaz birth control claims membership??"were identified as carrying a small risk of blood clot, in spite of thousands of lawsuits currently before the courts alleging injury and even death stemming from use of these third-generation products.

All oral contraceptives carry some risk of blood clot??"a risk that women who choose not to use oral contraceptives, don't have to worry about. And while there are certain advantages new-age oral contraceptives such as Beyaz birth control possess when compared with older birth control pills, some studies have suggested a relatively higher risk of Beyaz bleeding and Beyaz blood clots compared against older products.

But Dr. Kavita Nanda, identified as having helped the ACOG to draft its new recommendations, tempered the learned association's position by referencing "study weaknesses" in the various attempts to nail down the actual increased risk of drospirenone-based contraceptives like Beyaz birth control, over first and second-generation products.

Looking at the numbers as published in The Sentinel, the risk for blood clots in women who are not pregnant and not on The Pill works out to about one, to five cases out of 10,000. For women on birth control pills as a general population, that risk rises to between three, and nine cases per 10,000.

Some studies have suggested that Beyaz drospirenone and similar contraceptives would see 10 cases out of 10,000. But not all studies agree.

While ACOG cite a minimal increased risk for drospirenone-based birth control, such a position is offset against the over 13,500 lawsuits pending against Bayer Pharmaceuticals over Yasmin and Yaz. And it was last year, in the second week of December, that a US Food and Drug Administration (FDA) advisory panel ruled that oral contraceptives such as Beyaz should contain additional warnings with regard to the potential for increased risk of blood clots.

While Yasmin and Yaz lawsuits number into the thousands, it should be noted that the two related Bayer contraceptives have been on the market for much longer than Beyaz birth control, which received FDA approval in 2010. It's somewhat ironic that a year after approving Beyaz, in September 2010, the FDA was obligated to issue a warning with regard to the potentially higher risk for Beyaz blood clots.

Blogger Tom Lamb, in Drug Industry Watch, (11/26/12), noted that Bayer did not reference Beyaz in its most recent stockholder newsletter. And thus far there have been nary a word about a Beyaz lawsuit.

However, adverse incident reports are coming in. Lamb notes that between September 2010, when Beyaz drospirenone was approved, and May 1 of this year there were no fewer than 467 reports of Beyaz side effects contained within the FDA's Adverse Event Reporting System.

That would suggest that the side effects of Beyaz??"akin to Yasmin and Yaz??"would likely be revealed in the nation's courts at some point in the near future.