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FDA Cracks Down on Ibuprofen Pain Relief Gels

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

Regulators said in a statement Thursday the companies do not have federal permission to market their products, which mix the popular pain relief drug with 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.

The companies cited by the agency include: Tennessee-based Wonder Laboratories, New Mexico-based Meditrend and Alabama-based Progressive Emu Inc.

Among other issues, the FDA challenged the claim on Progressive Emu’s Emuprofen that “it does not cause the side effects that sometimes come with the oral medication.”

A manager for the Birmingham-based company said it has already responded to the FDA’s letter.

“We’ve made those changes and taken all the claims off of our labels and adhered to everything in their letter,” said Chris Binkley.

The other companies cited by the FDA 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.

The warning letters, dated Aug. 18, give the companies 15 business days to respond to the FDA citations.

The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing and marketing. The letters are not legally binding, but the agency can take companies to court if they are ignored.

Since the confirmation of new FDA chief Margaret Hamburg, the agency has made a series of rapid-fire enforcement actions against companies selling bogus or dangerous products.

Last month, the agency wrote to manufacturers of dietary supplements that contain metabolic steroids, warning them to pull their products from the market.

In June, regulators warned consumers to stop using the popular nasal decongestant Zicam Cold because it can permanently damage the sense of smell. The agency in May ordered dozens of Web sites to stop marketing more than 100 phony swine flu remedies
If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous drugs, bad products, or toxic injury etc then please contact the Fort Worth Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.

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