Dec. 7 (Bloomberg) -- More research is needed to determine whether Johnson & Johnson’s Ortho Evra birth-control patch is linked to an increased risk of blood clots, U.S. regulators said.
The Food and Drug Administration asked outside advisers to assess at a Dec. 9 meeting the risks and benefits of the patch and review studies showing an association between the contraceptive and a higher risk of blood clots, according to an agency staff report released yesterday. The agency isn’t required to follow the advisers’ recommendations.
In October, the FDA found the product from New Brunswick, New Jersey-based J&J was associated with “a significantly high risk” of blood clots compared with standard low-dose birth control pills.
“Based on the current studies, it is unclear whether the increased risk seen for thrombotic and thromboembolic events in some of the epidemiologic studies is actually due to use of Ortho Evra,” according to the FDA’s report.
The patch is the object of hundreds of lawsuits filed by women, most of whom allege Ortho Evra caused blood clots in the legs or lungs. J&J has voluntarily strengthened the product’s warning label three times since 2005 with the FDA’s agreement and paid at least $68.7 million to settle the claims, according to court records. J&J hasn’t disclosed revenue from Ortho Evra.
The agency’s October study also had found a significant blood-clot risk with a class of oral contraceptives containing drospirenone, such as Bayer AG’s Yaz. The same advisers are scheduled tomorrow to discuss the blood-clot association with Bayer’s pills. Drospirenone is similar to the natural female hormone progesterone.
The FDA also called for more studies of drospirenone pills in a staff report earlier yesterday ahead of the advisory meeting and said the risk associated with them also is unclear.
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