Roche's Fansidar
Executive Summary
Roche revised package insert for the antimalaria drug includes a bold-faced warning of fatalities that have occurred due to severe reactions, including Stevens-Johnson Syndrome and toxic epidermal necrolysis. Insert also restricts use of the drug in patients with suspected chloroquine-resistant Pjasmodium falciparum malaria and notes that Fansidar may be used prophylactically for people traveling to areas where chloroquine-resistant P. falciparum malaria is endemic. Roche sent the revised insert to 200,000 doctors and pharmacists the week of Aug. 19.
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