FDA Requires Label Changes For The Patch
After cautiously clearing Yaz for continued use Thursday, an FDA Advisory Panel Friday addressed post-marketing data showing similarly increased blood clot risks among users of the contraceptive patch. The committee, after having been clearly quite extensively briefed, heard testimony from Ortho Evra’s manufacturer and experts in epidemiology, gynecology and hematology. They also heard moving testimony about a young woman who died from a massive pulmonary embolism while using the Nuvaring, whose parents argued that not only the Patch, but most of the newer methods carry an increased clot risk that no woman should be allowed to take without being adequately informed.
The committee ruled that despite limitations of the data, the patch most likely carried a 1.5 times relative risk of blood clots compared to 2nd generation levonogestrel pills, but not necessarily higher than that of newer pills containing 3rd and 4th generation progestins and drosperinone. With a few dissenters, the committee voted to allow the Patch to stay on the market, but asked for Read more »
*This blog post was originally published at The Blog That Ate Manhattan*
