Overweight Women Warned About Using Birth Control Patch

FORT WORTH – The maker of the Evra* birth control patch sold in Canada is warning women there that they are at “particularly high risk” of developing blood clots if they are overweight and use the drug.

Canadian drug manufacturer Janssen-Ortho Inc. also says women should not expose the Evra birth control patch to sources of heat such as saunas and whirlpools, based on what the company calls a theoretical risk that doing so might cause an unintentional increase in estrogen exposure.

No such precautions exist for a similar birth control patch sold to women in the United States.

The new warnings were endorsed by Health Canada, the Canadian agency responsible for ensuring the safety and effectiveness of pharmaceutical products in that country.

Janssen-Ortho Inc. is part of Johnson & Johnson (NYSE:JNJ), which markets a birth control patch in the United States under the name Ortho Evra®. The patch is designed to prevent pregnancy by delivering the hormones estrogen and progestin through the skin.

In September 2006, Johnson & Johnson updated the label information for Ortho Evra to warn users of blood clots, stroke and other medical complications. The updated warning was based in part on a study that showed women using the patch were twice as likely to experience blood clots as were those who took a traditional contraceptive pill.

The Evra product contains less estrogen than the American Ortho Evra patch, but Janssen-Ortho says side effects for Ortho Evra apply equally to people who use Evra.

“The critical question now is whether warnings for women who use the patch in Canada should also apply to women in the United States,” says John David Hart of the Law Offices of John David Hart in Fort Worth, Texas, who represents women who have suffered harmful side effects after using the Ortho Evra patch. “If being overweight and using the Ortho Evra patch don’t mix, American women and their doctors need to know that. If exposure to saunas and other heat sources is dangerous, they need to be warned about that as well. But Johnson & Johnson isn’t saying anything in the United States.”

Johnson & Johnson had indicated it would release a so-called “Dear Doctor” letter to help instruct the health care community on how to interpret the September Ortho Evra warnings. But so far, the letter is not available on the FDA’s Web site, where such items routinely are posted. By contrast, the company did send such a letter regarding the recent Evra warnings to doctors in Canada.

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The Law Offices of John David Hart is a group of experienced and dedicated legal professionals working to protect the rights of people injured by the acts of others. Across the country, the firm represents people in cases of catastrophic personal injury, wrongful death, medical negligence, automobile and truck accidents, workplace injuries and other matters. More information is available at www.hartlaw.com.

This release was published on openPR.