FDA Warns About Counterfeit Birth Control
Overseas Site Sold Fake Birth Control Patches
UPDATED: 11:18 a.m. EST February 5, 2004
WASHINGTON -- Some women who ordered birth control patches from an overseas Internet site are not protected from pregnancy, according to federal health officials.
The Food and Drug Administration said a Web site -- www.rxpharmacy.ws -- is shipping counterfeit versions of a Johnson & Johnson birth control patch called Ortho Evra. The counterfeit version contains no active ingredients.
The counterfeits (pictured, right) are sent in plastic zippered bags without identifying materials, lot numbers, expiration dates or any other labeling information.
The counterfeit product is 1.5 inches square, brown in color, made of woven material, and has five holes that appear as red dots on the middle of the top side of the patch. This product also has a 1/4-inch orange square resembling gauze under the plastic liner on the back side of the patch.
The FDA warns women who ordered birth control patches from the site not to use them and advises them to contact their doctors if they already used the patches.
The site is apparently operated by American Style Products of New Delhi, India, and sells other products that purport to be versions of FDA-approved drugs.
The agency is investigating other products that the site sells, and it says consumers should treat any drugs purchased from the site as being suspect.
"This case highlights the serious risks posed by foreign drug operations that bypass FDA safeguards," said FDA commissioner Mark McClellan. "People are risking their health, in some cases, their very lives, by buying illegal Internet drugs."
The Web site is the only known source of the counterfeit patches. It's been shut down, but the FDA can't say how long it has been operating or how many women ordered the patches.
There are no reports of pregnancies linked to the patches.
The FDA-approved Ortho Evra contraceptive patch contains a combination of an estrogen and a progestin. The patch is applied to the skin of a woman's abdomen, upper outer arm, upper torso or buttock for seven days. A new patch is applied each week for three weeks, followed by one patch-free week.
The counterfeits (pictured, right) are sent in plastic zippered bags without identifying materials, lot numbers, expiration dates or any other labeling information.
The counterfeit product is 1.5 inches square, brown in color, made of woven material, and has five holes that appear as red dots on the middle of the top side of the patch. This product also has a 1/4-inch orange square resembling gauze under the plastic liner on the back side of the patch.
The FDA warns women who ordered birth control patches from the site not to use them and advises them to contact their doctors if they already used the patches.
The site is apparently operated by American Style Products of New Delhi, India, and sells other products that purport to be versions of FDA-approved drugs.
The agency is investigating other products that the site sells, and it says consumers should treat any drugs purchased from the site as being suspect.
"This case highlights the serious risks posed by foreign drug operations that bypass FDA safeguards," said FDA commissioner Mark McClellan. "People are risking their health, in some cases, their very lives, by buying illegal Internet drugs."
The Web site is the only known source of the counterfeit patches. It's been shut down, but the FDA can't say how long it has been operating or how many women ordered the patches.
There are no reports of pregnancies linked to the patches.
The FDA-approved Ortho Evra contraceptive patch contains a combination of an estrogen and a progestin. The patch is applied to the skin of a woman's abdomen, upper outer arm, upper torso or buttock for seven days. A new patch is applied each week for three weeks, followed by one patch-free week.
Distributed by Internet Broadcasting Systems, Inc. The Associated Press contributed to this report. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
