Petition to pull Ortho-Evra birth control patch from market filed

Amid rising concerns of dangerous side effects, a U.S. advocacy group filed a petition with the U.S. Food and Drug Administration on Thursday urging the authorities to remove the Ortho-Evra birth control patch from the market within six months.

Johnson & Johnson’s, Ortho-Evra birth control patch exposes women to dangerous levels of estrogen — posing a possible two-fold increased risk of blood clots, the petition filed by Public Citizen’s Health Research Group maintains.

"The considerable safety concern of high-dose, variable estrogen exposure tips the balance of risks and benefits against the availability of Ortho-Evra as a contraceptive," wrote Sidney Wolfe, head of the research group.

Compared to women who use standard oral contraceptives, those who use the Ortho-Evra patch experience increased side effects such as breast discomfort, severe menstrual pain, nausea and vomiting, and are more likely to stop using a contraceptive. In addition, the patch doesn't improve birth control, according to evidence compiled by Public Citizen.

Though the Ortho-Evra patch received FDA approval in 2001, but Ortho-Evra has seen its use slip. In January, company added warnings on the patch’s label when a study of women ages 15 to 44 found blood clots known as venous thromboembolisms were about twice as likely in women using the patch versus birth control pills.

However, since immediate removal of the Ortho-Evra patch from the market is not possible, Public Citizen suggested a six-month phase-out period. During this time, the patch would be available for refill prescriptions so as to allow switching over to other contraceptive forms.

Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen said, "Women deserve a level of risk at least comparable to or less than the pill for their hormonal contraceptive. The absence of any evidence of a unique benefit combined with the considerable safety problems of high-dose, variable estrogen exposure in Ortho-Evra tips the balance of risks and benefits against its availability as a contraceptive."

However, in defense the company spokeswoman stated, "Ortho-Evra is a safe and effective hormonal birth control option when used according to its labeling."

"Hormonal birth control methods have benefits and risks. The approved labeling has always stated the known risks associated with its use," she added.