FDA Actions

The FDA has alerted consumers that 3 Zicam^® products may result in long-lasting or permanent loss of smell (anosmia). Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs Kids Sized are all implicated, and the FDA is recommending that consumers stop using the products and throw them away. All 3 of these products contain zinc, which has not been shown to be effective in reducing the duration or severity of cold symptoms. Other Zicam oral tablets and lozenges have not been included in this advisory. Matrixx Initiatives, the manufacturer of Zicam, is offering refunds for the 3 products noted above. The company is also withdrawing the two adult products from the market — Cold Remedy Swabs Kids Sized had been previously withdrawn. There have been more than 130 reports of anosmia associated with intranasal Zicam product use ranging from 1 dose to long-term use.

The FDA has approved the first formulation of parenteral ibuprofen to treat fever and pain in hospitalized patients. The drug is given intravenously over 30 minutes in doses of 400-800 mg every 6 hours as needed for pain; lower doses are indicated for fever. As with all NSAIDs, caution is warranted when using injectable ibuprofen in patients with heart failure, renal dysfunction, increased risk for thrombosis, or history of ulcers or GI bleeding. Injectable ibuprofen is marketed by Cumberland Pharmaceuticals as Caldolor™.