FDA Deems Some Birth Control Patches Fake
Thursday, February 5th 2004, 12:00 am
By: News On 6
WASHINGTON (AP) _ An overseas Internet site is shipping counterfeit versions of a popular Johnson & Johnson birth control patch, versions that won't provide any protection against pregnancy, federal health officials warned Wednesday.
Do not use Ortho Evra patches _ or any other drugs _ ordered from the Web site www.rxpharmacy.ws the Food and Drug Administration warned.
While the contraceptive patch is the only drug so far proved a fake from that site, the FDA said consumers should consider its other products suspect, too. Contact a health provider immediately if you've used them, the FDA advised.
That Web site is the only known source of the counterfeit patches, said the FDA, which is investigating the fraud's source.
The site appeared to have shut down by Wednesday, but the FDA couldn't say how long it had been operating or how many U.S. women might have ordered the patches. It has no reports of pregnancies linked to them.
The fake birth control was shipped from India, and the Web site apparently was operated by an entity called American Style Products of New Delhi.
The Web site claimed to be offering J&J's FDA-approved patches, complete with pictures of the real thing, said FDA Associate Commissioner John Taylor.
A customer sparked the FDA's investigation when she complained to J&J that she didn't get what she ordered, Taylor said. Instead of the official patch, with its special sealed packaging and company label, she received a plastic bag full of patches with no label or other identifying information.
Testing showed the patches contained no contraceptive ingredient.
In addition to patches ordered from the one Web site FDA named, the agency urged women not to use Ortho Evra patches from other sites if they seem suspect _ for example, lacking a label that bears a lot number and expiration date. The fake patch is brown and made of a woven material.
``It underscores the message that if it looks untoward, that you need to report it,'' Taylor said.
The real Ortho Evra patch is a thin beige film that comes sealed in a white pouch with a J&J label containing a lot number and expiration date. The pouch is packaged inside a green and white box with usage instructions.
Counterfeit drugs are a growing problem. While the biggest fake-drug case to date _ more than 150,000 bottles of the cholesterol medicine Lipitor _ involved regular drugstores, the FDA says Internet-sold drugs are more likely to be fraudulent.
Internet buying of prescription drugs is on the rise as more Americans hunt for cheaper medicines overseas.