Ortho Evra Label Updated for Greater Clot Risk

September 2006

The controversial birth-control patch, Ortho Evra, will have more data concerning the drug’s risk on its label. Designed to replace taking a pill daily, the patch is applied only once a week. But studies show it carries a greater risk of producing blood clots in women over other traditional forms of birth-control.

The label will now include data from two recent studies that show different results, according to the Food and Drug Administration (FDA). One study shows no increased risk of blood clots from the patch, while the other study shows a two-fold increase in the risk of blood clots in women.

Typically, three to five women out of every 10,000 experience clots while using a pill form method of contraception. With the patch, six women out of every 10,000 will experience clotting in a year’s time. In the meantime, the FDA will continue the studies that include 500,000 women ages 18-24 for another 18 to 24 months.

Ortho Evra’s label was last altered in November 2005 to warn of a possible increased risk. The FDA advises women and their doctors to weigh their risk of blood clots with their risk of getting pregnant.

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