The U.S. Food and Drug Administration informed consumers and healthcare professionals of warning letters sent to eight topical Ibuprofen drug companies. The eight topical pain medication makers are producing and selling unapproved drugs to American consumers.
West Palm Beach injury lawyers-Food and Drug Administration issues warning letters to drug companies selling unapproved Ibuprofen topical pain meds.
West Palm Beach, FL–The United States Food and Drug Administration (FDA) http://www.fda.gov/default.htm a federal agency operating under the U.S. Department of Health and Human Sevices (HHS) http://www.hhs.gov/ announced warning letters were sent to eight topical Ibuprofen pain medication manufacturers last week. The August alert, by federal officials, placed consumers and healthcare workers on alert for the unapproved topical pain medications being marketed and sold over-the-counter as safe and effective. The FDA has approved Ibuprofen, an anti-inflammatory pain medication, for oral use and has not approved the new topical drug application currently being sold and marketed over-the-counter by drug companies to unsuspecting consumers.
Topical ibuprofen is being promoted as a safer alternative to oral ibuprofen because of known side effects of taking the approved oral over-the-counter dosing. Oral ibuprofen pain medications are known to cause stomach ulcers and some cardiovascular effects with long term use. The safety, efficacy, and topical combinations of ibuprofen have not been reviewed by the FDA as required by law. The following manufacturers have been put on alert and consumers should stop buying and using these products at once. Retailers are ordered to cease and desist the sale of these unapproved over-the-counter preparations.
-Emuprofen (Progressive Emu, Inc.)
-BioEntopic 15% Ibuprofen Creme (BioCentric Laboratories, Inc.)
-Ibunex Topical Ibuprofen (Core Products International, Inc.)
-LoPain AF 15% Creme (Geomatrix Health Products)
-IB-RELIEF (MEKT LLC)
-Profen HP (Ridge Medical Produts)
-IbuPRO-10 Plus (Meditrend, Inc. Dba Progena Professional Formulations)
-IBU-RELIEF 12 (Wonder Laboratories)
If you or someone you know has suffered a drug related injury because of unapproved drug ingredients in over-the-counter medications you may be entitled to compensation for your damages and injuries. Contacting a Florida drug injury lawyer may help you recover.
Legal news reporter Heather L. Ryan for Florida drug injury lawyers.
Heather L. Ryan, R.N., C.L.N.C- Heather Ryan is a Certified Legal Nurse Consultant with 15 years of experience in the health care industry. Her expertise in reviewing medical records and assisting lawyers with the determination as to whether legal action should be taken provides an invaluable asset to the newsroom. Medical-malpractice, products liability, personal injury and workers’ compensation are some of the recent areas of litigation Ms. Ryan has focused her efforts on. A member of the Florida Justice Association, Heather maintains a long list of certifications and credentials to support her areas of expertise and stays up-to-date with her clinical knowledge working as an emergency room/trauma nurse, at a Level 1, Adult/Pediatric trauma and teaching institution in South Florida.