Birth control patch linked to higher fatality rate

Early warning signs
In 2000, doctors at the FDA reviewing clinical trials of the wafer-thin, plastic patch warned that blood clots could be a problem if it was approved.

In those trials, two of the 3,300 women using the patch were treated for blood clots that traveled to their lungs. Ortho McNeil says one of those women shouldn’t be counted because she had undergone surgery. But an FDA reviewer, using capital letters and underscoring his comments, took issue with Ortho McNeil.

“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases ...,” said the report. “The incidence rates quoted by the sponsor may be misleading.”

The reviewer said “the label should clearly reflect this reviewer’s safety concern about a potential increased risk.” It would be important to study users after the patch came on the market for clot problems, he wrote.

But when the patch was approved in the U.S. in 2001, there were no requirements for follow-up studies beyond routine FDA reviews of reports called in by consumers, doctors and manufacturers.

The label’s safety warning says two different and seemingly contradictory things: First, it says the patch is expected to be associated with similar risks as the pill. Then, it says it is unknown if the risk of blood clots from the patch is different from the pill.

The AP reviewed what has happened since the patch came on the market in 2002.

Hormones enter bloodstream directly
The FDA responded to a FOIA request by providing the AP with a database that contained about 16,000 different reports of adverse reactions associated with the patch.

These ranged from mild rashes to deaths, and there were many duplicate reports. Within this collection of reports, the AP found 23 different deaths associated with the patch. The primary cause of death in those reports isn’t always clear — some mention suicide, others abortion. Doctors who reviewed the 23 cases found about 17 that appeared to be clot-related, including 12 from last year.

“That number of deaths certainly sounds suspicious,” said Dr. Pamela Berens, associate professor of obstetrics and gynecology at the University of Texas Medical School at Houston. “There may be something about the way the drug is metabolized that could increase the risk for clots.”

Although the estrogen levels are similar in the patch and the pill, the hormones in a pill must be processed through the intestinal tract before they enter the blood stream. Hormones in the patch, on the other hand, go directly into the bloodstream.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, a consumer advocacy organization founded by Ralph Nader, said that the deaths and high rate of clots are “worrisome” and should be investigated.

“These days, more often than not the problems with a drug show up after they’re approved,” he said.

But Dr. Daniel Shames, the FDA’s director of the Division of Reproductive and Urological Drug Products, who approved the agency’s medical review, said he has reviewed cases of women who died using the patch and saw no cause for alarm.

“We think the death rate here is of concern, but it’s not different than what we expect,” he said. “As of right now we still believe there’s nothing that would precipitate our doing anything additional to follow up on these reports.”

And other doctors who prescribe the patch warned that women should not overreact to news of deaths. It is more risky to remove the patch and become pregnant, several pointed out.

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