Birth-Control Patch Tied to Clot Risk

By Randolph E. Schmid

Risks of blood clots in legs and lungs are twice as high for women using the birth-control patch instead of the pill, says a study reported by the drug maker and the Food and Drug Administration.

Dr. Daniel Shames of the FDA said Friday the new findings don’t require immediate action by the government, but he urged concerned women to discuss the risk with their physicians.

One new study found users of the Ortho Evra patch had twice the risk of clots compared with women taking birth-control pills, although a second analysis found no difference in risk between the two forms of birth control.

“For some people the patch may be better because some people don’t reliably take the pill, or don’t want to take the pill or forget the pill,” Shames said. “So the patch does offer them some alternative for contraception.

“On the other hand, we need to interpret what these results mean,” he said. “But these results are preliminary so we can’t make hard comments about it.”

The results of the two studies were made public Thursday by the patch’s manufacturer, Ortho Women’s Health & Urology. The Raritan, N.J.-based company is owned by Johnson & Johnson.

Last year, an investigation by the Associated Press, citing federal death and injury reports, found higher rates of blood clots in women using the patch.

While one of the newly reported studies found no increased risk of clots, the interim results from the second suggested a twofold increase in the risk of venous thromboembolic events, or clots in the legs and lungs, in women using the patch, Ortho said.

The ongoing studies also are looking at the risk of heart attacks and strokes among users of the two types of contraception. Currently there is no difference but the numbers are small and it will take another 18 months to see if a difference occurs, Shames said.

The company said the risk of clots remains rare and that they have been reported as a potential risk of all hormonal contraceptives.

Release of the interim results comes four months after the FDA warned women that the increased levels of hormones released by the patch put them at higher risk of blood clots and other serious side effects.

Additions to the patch label made in November warned women that they would be exposed to about 60 percent more estrogen than those who use birth-control pills.