FDA Cracks Down on Ibuprofen Pain Relief Gels

August 20, 2009
Associated Press
Matthew Perrone

The Food and Drug Administration has issued warnings to eight companies for illegally marketing pain relief ointments containing ibuprofren.

Regulators said in a statement Thursday the companies do not have federal persmission to market their products, which mix the popular pain relief drug wtih other ingredients. While ibuprofen is available in a variety of tablets like Advil, the FDA has not approved any ointments containing the drug.

“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.

Ibuprofen ointments are often promoted as a safer alternative to pills because they do not carry side effects like stomach ulcers. However, the FDA said there is no research to support that claim. More…

PainCare MD