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Unapproved Ear Drops Targeted by FDA

Posted 1 Jul 2015 by Drugs.com

WEDNESDAY, July 1, 2015 – The prescription drops your child is using for ear pain could be among 16 unapproved medications targeted this week by the U.S. Food and Drug Administration. These drugs, prescribed and sold for years to relieve ear pain and swelling, have not been evaluated for safety, quality and effectiveness, the agency said Wednesday. The agency notified the drugs' makers to stop marketing the drops following a few reports of local allergic reactions of the ear, eye, face, neck and mouth. The drops can also cause itching, stinging, burning and irritation of the ear, according to an FDA news release. "If we don't know whether these drugs have any benefits, we should not accept any possible risk of side effects," said the FDA's Dr. Charles Lee in the news release. The FDA did not release the names of the companies or the medications involved, but did note that "unapproved ... Read more

Related support groups: Otitis Media, Maintain, Orajel, Benzocaine, Anbesol, Anusol, Pramoxine, Vagisil, Allergen, Lanacane, Caladryl, Galzin, Analpram-HC, Dendracin, Caladryl Clear, Otitis Externa, Solarcaine, Antipyrine/Benzocaine, Zilactin Toothache, Cough-X Cough Relief

FDA Bans Unapproved Prescription Cough, Cold and Allergy Meds

Posted 2 Mar 2011 by Drugs.com

WEDNESDAY, March 2 – The U.S. Food and Drug Administration said Wednesday that it plans to remove about 500 unapproved prescription cough, cold, and allergy medicines from pharmacy shelves. These drugs have not been evaluated by the FDA for safety and effectiveness, and they may be riskier to take than approved over-the-counter (OTC) drugs that treat these same conditions, agency officials explained. "This action is necessary to protect consumers from the potential risks posed by unapproved drugs, because we don't know what's in them, whether they work properly or how they are made," Deborah M. Autor, director of the agency's Office of Compliance at the Center for Drug Evaluation and Research, said during a morning news conference. Of particular concern are drugs that have time-release formulations, Autor said. "We know from experience that these type of products are complicated to ... Read more

Related support groups: Benadryl, Mucinex, Sta-D, Diphenhydramine, Cold Symptoms, Pseudoephedrine, Sudafed, NyQuil, Guaifenesin, Mucinex DM, Tylenol PM, Dry Cough, Cheratussin AC, Robitussin, Phenylephrine, Claritin-D, Dextromethorphan, Mucinex D, Chlorpheniramine, Unisom

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