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US FDA describes reports of pneumonitis with Lariam

This article was originally published in Scrip

Executive Summary

Infrequent reports of pneumonitis or eosinophilic pneumonia associated with the use of the antimalarial mefloquine (marketed as Lariam and generics) have been reviewed in the third issue of the US FDA's Drug Safety Newsletter, which alerts practitioners to postmarketing events. The agency said the review was prompted by the manufacturer's request to revise the "Adverse Reactions-Postmarketing" section of the data sheet to include this new safety information (ie, pneumonitis of possible allergy aetiology); the product labelling has been updated to reflect the new data. The FDA added that mefloquine is usually well tolerated, but that there have been five reported cases of mefloquine-associated eosiniophilic pneumonia or pneumonitis in the medical literature. Additionally, from May 1989 to January 2008, the agency said it had received 13 reports (three from the US and 10 non-US) of pneumonitis associated with mefloquine therapy. Of the 13 case reports, five are reported in the medical literature.

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