FDA panel mixed on Ortho Evra

The majority of members of the US Food and Drug Administration’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on Friday voted (19 to five) that US health care giant Johnson & Johnson’s (NYSE: JNJ) contraceptive patch Ortho Evra (norelgestromin, ethinyl estradiol) risks were outweighed by its benefits, such as pregnancy prevention through a once-weekly application.

However, they also voted 20 to three, with one abstention, that the current label for Ortho Evra, the only patch contraceptive sold in the USA which was approved by the FDA in 2001, inadequately reflects the risks of blood clots women face by using it. Just a day earlier, the same panel also gave a mixed reaction on Bayer’s drospirenone-containing contraceptives Yaz and Yasmin (The Pharma Letter December 9).

Clinical studies of Ortho Evra's blood clot risk have reached differing conclusions over the years. At least two found that patch users have twice the risk of clots as women taking contraceptive pills. Even a slightly higher risk can be critical because blood clots can trigger heart attacks, strokes and blockages in lungs or blood vessels, which in rare cases have been fatal, even among young women. J&J does not provide sales figures for Ortho Evra but, according to an Associated Press report, prescriptions for the product have declined steadily over the last five years, from 5 million in 2006 to about 1.3 million last year.