The warning comes as part of series of enforcement actions undertaken by the new FDA chief Margaret Hamburg against companies selling spurious and hazardous goods.
No proof to substantiate claims
Ibuprofen is present in a wide assortment of tablets like Advil. However, till date the FDA has not approved any ointments that contain this drug. Therefore, companies that mix the popular pain relief drug with other ingredients are doing so illegally.
Companies tout Ibuprofen ointments as a better alternative to pills as the ointment does not carry adverse side effects like stomach ulcers.
The FDA contends that there is no data to back this claim. "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 companies under scanner
The FDA is closely monitoring the Tennessee-based Wonder Laboratories, Meditrend based out of New Mexico and Alabama-based Progressive Emu Inc in this regard.
Biocentric Laboratories, Core Products International, Geromatrix Health Products, MEKT LLC, and Ridge Medical Products have also received warning letters from the health watchdog.
These companies are required to respond to the clarifications sought by the FDA within 15 working days. The response to the missive shot out from the FDA’s desk is not a legal binding on the companies; however the health agency can drag the companies to court in the event of a non response.
The products included in the warnings were Emuprofen, BioEntopic 15 percent Ibuprofen Crème, Ibunex Topical Ibuprofen, LoPain AF 15 percent Ibuprofen Crème, IB-Relief, Profen HP, IbuPRO-10 Plus and IBU-Relief 12.
In its citations the FDA had questioned the assertion of Progressive Emu's Emuprofen that "it does not cause the side effects that sometimes come with the oral medication."
In a swift response to the allegation, the company has already made the requisite changes taken off all the claims from the medicine’s labels.
Post new comment