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US Marshals seize Auralgan otic solution
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US Marshals recently seized all lots of a drug commonly used to treat ear pain and inflammation.
Acting on behalf of the FDA, the US Marshals Service apprehended an estimated $16.5 million worth of Auralgan otic solution (antipyrine-benzocaine, Deston Therapeutics) in Brooks, Ky., where the drug is warehoused for Integrated Commercialized Solutions Inc.
Sales of this product in the United States violate federal law because the product does not have FDA approval. The drug’s labeling does not include adequate directions for use, according to a press release from the FDA.
“The FDA is committed to taking enforcement action against companies marketing drugs that do not meet federal standards for safety, effectiveness and quality,” said Deborah M. Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We will remain vigilant in our efforts to protect consumers from unapproved products.”
The FDA issued a warning letter to the manufacturer in February 2010, citing the company for distributing unapproved new drugs and misbranded drugs. The FDA also warned the manufacturer in April, June and September that the drug was unapproved, and the company continued distributing the drug in violation of the Federal Food, Drug, and Cosmetic Act, according to the FDA.
The FDA’s order to seize the otic solution is part of the FDA’s Unapproved Drugs Initiative, which was established in 2006 to get unapproved drugs approved or off the market.
More information can be found at
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm243638.htm.
This information about Auralgan is interesting from several perspectives. The Auralgan product, marketed for acute otitis externa and as adjunct analgesic and antiinflammatory therapy for acute otitis media, was re-formulated over 2 years ago, to contain acetic acid and polycosanol (in addition to antipyrine and benzocaine, for local analgesia). The price of this product was also "re-formulated," to well over $100, as compared to just a few dollars for a generically available product containing antipyrine and benzocaine. The original Auralgan product had never received approval by the FDA, as it was an older product and was "grandfathered" in over the years. The newer product, as well, has not received approval (for proven safety, efficacy, manufacturing practices, and accurate informational labeling) by the FDA. Thus, its removal from the market. As with many facets of life, medication products, at times, can also be misleading and confusing (unfortunately).
– Edward A. Bell, PharmD, BCPS
Pharmacology Consult, Infectious Diseases in Children
Disclosures: Dr. Bell reports no relevant financial disclosures.
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