Chrome 2001
.
The Trusted Source InteliHealth Aetna InteliHealth Aetna InteliHealth
Enter Drug Name . Enter Search Term
     
. .
. .
.
Home
Health Commentaries
InteliHealth Dental
Drug Resource Center
Ask the Expert
Interactive Tools

InteliHealth Policies
Site Map
Diseases & Conditions Healthy Lifestyle Your Health Look It Up
Health News Health News
.
Associated Press

Group Asks Government to End Use of Birth-Control Patch
May 8, 2008

WASHINGTON (AP) -- A consumer advocacy group petitioned the government Thursday to pull the birth-control patch off the market, calling it far riskier than the pill.

"Ortho-Evra is a poor choice for women," Dr. Sidney Wolfe of Public Citizen wrote the Food and Drug Administration.

Warnings about the Ortho-Evra weekly patch have escalated since a 2005 investigation by The Associated Press found patch users suffer higher rates of life-threatening blood clots than women who take birth-control pills.

Blood clots are a rare side effect for estrogen-related products. Some, but not all, studies of the risk suggest patch users have twice the risk of clots in the legs and lungs as do women who swallow the pill, because patients absorb up to 60 percent more estrogen via the patch. The FDA updated Ortho-Evra's label in 2005, 2006 and earlier this year with clot warnings.

Demand has dropped, from about 9.9 million prescriptions filled in 2004 to 2.7 million filled in 2007, Wolfe wrote.

But Wolfe argued that the patch offers no better contraception in return for the extra risk. And he said lawsuits by women who claim they were harmed by the patch have unearthed two previously unpublished studies from Johnson & Johnson researchers that found higher estrogen exposure from the patch even before it won FDA approval in 2001.

A spokeswoman for patch maker Ortho Women's Health & Urology, a J&J company, said "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," said Gloria Vanderham. "The approved labeling has always stated the known risks associated with its use."

The FDA said it has not had an opportunity to review the petition and, when it does, it will respond directly to Public Citizen.

Despite the risk, Wolfe said abruptly cutting off users could result in unwanted pregnancies. So he urged the FDA to phase out patch sales with a six-month period during which existing users could only get refills, allowing them time to switch to another contraceptive.

Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

.
InteliHealth
. . . .
.
More News
InteliHealth .
.
Top News
General Health
This Week In Health
Addiction
Allergy
Alzheimer's
Asthma
Arthritis
Babies
Breast Cancer
Cancer
Caregiving
Cervical Cancer
Children's Health
Cholesterol
Complementary & Alternative Medicine
Dental / Oral Health
Depression
Diabetes
Ear, Nose And Throat
Eyes
Family Health
Fitness
Headache
Heart Health
HIV / AIDS
Infectious Diseases
Lung Cancer
Medications
Men's Health
Mental Health
Nutrition News
Multiple Sclerosis
Nutrition Guide
Parkinson's
Pregnancy
Prevention
Prostate Cancer
Senior Health
Sexual / Reproductive Health
Sleep
Tobacco Cessation
STDs
Stress Reduction
Stroke
Weight Management
Today In Health History
Women's Health
Workplace Health
.
.
.
.
InteliHealth

   
.
.   HONcode
.
Chrome 2001
Chrome 2001