Birth Control Patch Too Dangerous to Stay on Market 10-15-08

by: David Gutierrez

Johnson & Johnson's Ortho-Evra birth control patch exposes women to too much risk for too little benefit and should be pulled from the market, the nonprofit group Public Citizen warned in a petition submitted to the FDA.

"Ortho-Evra is a poor choice for women," wrote Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

The Ortho-Evra patch is designed to be worn on the skin and changed once weekly, in contrast to birth control pills, which are taken daily. When Johnson & Johnson introduced the patch in 2001, it said that it would be preferable to a pill because it would provide lower and more stable estrogen levels, and would be easier for women to take. But studies have shown that the first two claims are not true, and Public Citizen says that improved compliance is not enough of a benefit to outweigh the serious risks that have emerged.

According to a review conducted by Public Citizen, the birth control patch exposes women to up to 60 percent more estrogen than the pill, and a variation in hormone levels anywhere from 1.2 to 3.5 times higher.

"Had Ortho-Evra been designed as a pill, it is unlikely to have been approved because of its increased estrogen content," Wolfe said.

In 1988, the FDA banned birth-control pills containing more than 50 micrograms of estrogen, due to the risk of fatal blood clots. Ortho-Evra exposes patients to the equivalent of a 56 microgram pill or more.

Studies suggest that women using Ortho-Evra have twice the risk of blood clots as women taking the pill, and are also at increased risk for other side effects such as breast discomfort, nausea, vomiting and severe menstrual pain.

The FDA has updated the drug's label with warnings about blood clots three times since 2005, and sales have dropped from 9.9 million prescriptions in 2004 to 2.7 million in 2007.

Public Citizen has asked the FDA to phase out sales of the drug over a six-month period.

Comments:

Rhythm method and lambskin or non lubricated condoms are the healthiest choices for married couples. Any hormone method has serious risks.