Counterfeit contraceptive patches that were hawked on a Web site based in India contain no active ingredients and do not protect against pregnancy, the Food and Drug Administration has warned.
So far there have been no reports of any pregnancies or adverse effects related to use of the counterfeit patch, according to a spokeswoman for Ortho-McNeil Pharmaceutical, the Johnson & Johnson subsidiary that makes Ortho Evra, the genuine product.
Currently, Ortho Evra is the only transdermal contraceptive patch approved by the FDA.
The existence of the counterfeit patches came to light in January, when a woman notified Ortho-McNeil that the patches she had ordered from the site, www.rxpharmacy.ws, did not resemble the standard Ortho Evra patch. She sent the patches to Johnson & Johnson, which tested them and confirmed that they were inactive.
The counterfeit contraceptive patches are 1 1/2-inch square, brown, made of woven material, and have five holes that appear as red dots in the middle of the top side of the patch.
They "resemble a bandage," Mona Terrell, the Ortho-McNeil spokeswoman, told this newspaper.
The sham patches also have a 3/4-inch orange square resembling gauze under the plastic liner on the back. They do not come in sealed pouches and have no information on lot numbers or expiration dates.
In contrast, the FDA-approved Ortho Evra contraceptive patch is 1 3/4-inch square, beige, made of a thin film, and comes packaged in a sealed, opaque, white pouch with the product label attached to one side of the pouch. The label bears the product's lot number and expiration date, which also appear on the back of the pouch.
The Web site, which has since been shut down, was also selling other questionable versions of FDA-approved drugs. Those products are now under investigation.
Neither the FDA nor Ortho-McNeil is aware of any other site selling the counterfeits.
It is not known how many counterfeit patches or other counterfeit medications were sold from that site.
Consumers who purchase drugs over the Internet should do so only from sites bearing the Verified Internet Pharmacy Practice Sites seal, which indicates that they are certified by the National Association of Boards of Pharmacy, Ms. Terrell advised.
Women with questions about the counterfeit Ortho Evra patches can call Ortho-McNeil customer care at 1-800-682-6532. Ms. Terrell also requested that doctors call that number if any of their patients bring them a suspect Ortho Evra patch.
BY NORRA MACREADY
Los Angeles Bureau
COPYRIGHT 2004 International Medical News Group
COPYRIGHT 2004 Gale Group