Birth control patch linked to higher fatality rate

'You can use a patch safely'
Dr. Philip Darney, a professor of obstetrics and gynecology at the University of California, San Francisco, and a leading contraceptive researcher, cautioned that the FDA’s adverse event reports tend to be inflated for newer products like the patch.

Patients and doctors are more likely to contact the FDA when they have a bad reaction to a new drug than for something that has been on the market for a long time, he said. In addition, women using the patch are likely to either be new to hormonal birth control or have reacted poorly to the pill and are looking for a change. The result is that the pool of women using the patch are at higher risk than birth control users at large.

He tells patients, “If you can use a pill safely, you can use a patch safely, and we’re going to know a lot more later as more women use patches,” he said.

Ortho McNeil recommended that the AP speak to two doctors, Dr. Hilda Hutcherson, co-director of the NY Center for Women’s Sexual Health and a professor at Columbia University Medical Center, and Dr. Vanessa Cullins, vice president of medical affairs at Planned Parenthood Federation of America. Both doctors have served in the past as paid advisers to Ortho McNeil.

Hutcherson said the risks of blood clots from hormones are well known, and that “what has happened with the patch is consistent.”

Cullins said she did her own comparison of data for the pill and patch and found the patch is safer than expected.

“My research was to determine whether or not the expected number of deaths from the pill was lower than what was seen with the number of deaths reported with Ortho Evra. I found the opposite,” said Cullins, who has done research, consulted for and been a speaker for Ortho McNeil and other drug companies.

Cullins said she reviewed the deaths looking at “women years” rather than current users. Women years is a measure that takes into account that different people use a particular contraceptive for different periods of time. For example, if three women each used a patch for four months, that would count as one woman year rather than three current users.

Cullins reviewed patch users from 2002, when the patch came on the market, until late 2003. For that period, Cullins said she would have expected 22 deaths and found only 6.

The AP reviewed the deaths looking at both women years and current users, but used more recent data, focusing on 2004 when the patch had been much more widely adopted.

MORE FROM WOMEN'S HEALTH

Women's health Section Front

Report: VA inadequately serving women Just how bad are your health vices? Don't let your turkey wattle give away your age Banking ovaries may extend baby-making span Can your bikini line forecast your fertility? Puzzling disparities found in childbirth injuries More women look away from abnormal babies Mother pleads guilty to drunken breast-feeding ‘Phantom fat’ can linger after weight loss Ow! Beware of bikini wax mishaps Women's health Section Front   Add Women's health headlines to your news reader: