FDA - Ibuprofen Pain Relief Gels Are Unproven

A new tougher Food and Drug Administration (FDA) is issuing another crackdown – this time on creams that claim to relieve pain because they contain ibuprofen, among other active ingredients.

A number of Ibuprofen ointments or creams claim they are safer than pills because they do not cause stomach ulcers. The FDA says there has been no research supporting that claims and that the over-the-counter products are unapproved.

"These companies have an obligation to demonstrate to the FDA that their products are safe and effective, and they have failed to do so," said Deborah Autor, director of FDA's office of compliance.

The FDA says companies must submit an application for new drug approval.

Eight companies have received warning letters from the FDA to stop marketing the drugs, among them, Tennessee-based Wonder Laboratories, New Mexico-based Meditrend and Alabama-based Progressive Emu Inc.

Progressive Emu says it has already responded to the FA and removed all claims off of its labels.

Other companies cited are: Colorado-based Biocentric Laboratories, Wisconsin-based Core Products International, Florida-based Geromatrix Health Products, New Jersey-based MEKT LLC, and Texas-based Ridge Medical Products.

Ibuprofen is available in tablet form such as Advil, as a pain reliever.

As part of a more regulatory-conscious FDA, chief Margaret Hamburg has issued a number of enforcement actions against companies that make unsubstantiated claims or sell dangerous products. Last month makers of supplements that contain metabolic steroids were told to pull their products from the market.

And in June, consumers were warned that the cold remedy, Zicam Cold, can permanently damage the sense of smell, while the FDA has also told dozens of Web sites to stop making phony swine flu remedies,

Source : www.injuryboard.com