The benefits of the Ortho Evra patch outweigh the clot dangers, FDA reproductive and drug safety advisory panels said today in a 19-5 vote. The agency should change the information label to better reflect the risk, the panels said at a meeting today in Adelphi, Maryland. The agency doesn’t have to follow the recommendations.
Studies have shown conflicting evidence about whether women who use New Brunswick, New Jersey-based J&J’s patch or contraceptive pills containing drospirenone have a higher risk of blood clots than if they take older birth control pills that don’t contain drospirenone. Those ambiguous results prompted the FDA to request the reviews.
“I felt the risk was quite small,” said Geri Hewitt, a panel member with the Ohio State University Department of Obstetrics and Gynecology in Columbus. Ortho Evra is “a unique product and nothing else like it was available.”
The same advisers yesterday voted 15-11 that the benefits of Leverkusen, Germany-based Bayer AG’s Yaz and similar birth control pills outweigh the potential for clots. The panel recommended information labels be strengthened to clarify the risks.
Women who use the patch have a 55 percent greater chance of experiencing blood clots compared with those who use older low- dose hormonal pills, the agency found in an October study. The weekly patch is marketed by J&J as a more convenient option to daily oral contraceptives.
The FDA found the incidence of blood clots in women using the patch for one year is 14 in 10,000 women compared with 8 in 10,000 women on older pills, according to the October report.
The advisers voted 20-3 with one abstention the label isn’t adequate. The patch now carries a warning that women who smoke and who are older than 35 shouldn’t use the product because they risk death from heart attack, blood clots or stroke. The boxed warning also refers to four studies that examined blood clotting, which found dangers ranging from a doubling of the risk to no potential for harm.
The patch is the object of hundreds of lawsuits filed by women who allege Ortho Evra caused blood clots. 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 claims, according to court records.
Panel members were concerned the results of studies on drospirenone-containing pills may have been affected by factors that weren’t studied such as women’s body mass index, smoking habits and family history.
Panel members had the same concerns with the Ortho Evra studies, though their unease that the factors were unexamined was not as strong with the patch.
The FDA pushed for more studies covering such factors in a Dec. 6 staff report prepared for this week’s meetings.
Bayer’s Yaz and Yasmin brought in $1.5 billion in sales for the Leverkusen, Germany-based drugmaker last year as its second best-selling product, less than the $1.8 billion in 2009. Teva Pharmaceutical Industries Ltd., based in Petach Tikva, Israel, introduced a generic version of Yaz in May 2010.