FDA Actions
The FDA has issued a Safety Communication regarding the oral antifungal ketoconazole that includes limiting the drug’s use. The warning states that ketoconazole should never be used as a first-line agent due to the risk of liver toxicity, adrenal insufficiency, and drug interactions. The new guidance states that ketoconazole should only be used “when alternative antifungal therapies are not available or tolerated.” In addition, the agency has revised the list of indications for the drug, removing dermatophyte and Candida infections.
The FDA has also issued a Safety Communication about the antimalarial drug mefloquine hydrochloride regarding neurologic and psychiatric side effects. The drug is used for treatment of malaria but more commonly for prevention of Plasmodium falciparum (including chloroquine-resistant P. falciparum) and P. vivax. Neurologic side effects — which may be permanent — include dizziness, loss of balance, and tinnitus. Psychiatric side effects include anxiety, paranoia, depression, or hallucinations. The brand form of mefloquine (known as Lariam) is no longer marketed, but several generic forms of the drug are available. The new warnings are contained in a boxed warning — the FDA’s most serious warning. The drug was recently in the news regarding a number of violent military incidents among soldiers taking the drug, including the murder of 16 Afghan civilians last year.
A nasal steroid spray may soon be available over the counter (OTC). The FDA’s Nonprescription Drugs Advisory Committee has recommended the switch to OTC for Sanofi’s triamcinolone acetonide (Nasacort AQ), the popular steroid nasal spray for the treatment of seasonal and perennial allergic rhinitis. The drug was originally approved in 1996 for use in adults and children ages 2 years and older, and has been widely used since. If approved by the full FDA later this year, it would be the first nasal steroid to be sold OTC. The drug has been available as a generic since 2008.
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