Fake Contraceptive Patches Sold on Internet
FDA, Maker Say Patches Won't Prevent Pregnancy
Feb. 5, 2004 -- The FDA is warning the public about an overseas Internet site selling counterfeit contraceptive patches that contain no active ingredients. These counterfeit patches provide no protection against pregnancy.
This Internet site -- www.rxpharmacy.ws -- apparently is operated by American Style Products of New Delhi, the FDA says. The site also sells other products that purport to be versions of FDA-approved drugs. The FDA is investigating these other products as well, and urges consumers to treat any drugs purchased from this firm as being suspect. None of these products should be considered safe or effective. Consumers who have any of these products should not use them, but instead contact their healthcare providers immediately.
"FDA will continue to do all it can to protect Americans from unsafe and counterfeit drugs purchased from illegal foreign sites," says FDA Commissioner Mark B. McClellan, MD, PhD, in a news release. "This case highlights the serious risks posed by foreign drug operations that bypass FDA safeguards. People are risking their health, in some cases their very lives, by buying illegal Internet drugs."
To protect the public health, the FDA has obtained the cooperation of a U.S.-based Internet service provider in shutting down service to this site.
The site promoted the counterfeit contraceptive patches as being Ortho Evra transdermal patches, which are FDA approved, and made by Johnson and Johnson. The pharmaceutical company is also warning consumers about using these fake birth control patches.
Instead customers receive packages of patches without the active ingredient necessary to make the patches effective. Moreover, the counterfeits are sent in simple plastic zip-lock bags without identifying materials, lot numbers, expiration dating or any other labeling information needed to safely and effectively use this prescription product.
The FDA-approved Ortho Evra contraceptive patch is an adhesive patch that contains a combination of an estrogen and a progestin for contraception. 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 (21 total days), followed by one patch-free week.