CHEMICAL BUSINESS NEWSBASE: ABBOTT LABORATORIES NEWS & REPORT
(C) 2002
Thursday, August 22, 2002
FDA approves new safety data for Malarone.

The US Food and Drug Administration (FDA) approved the addition of new safety data to the prescribing information of GlaxoSmithKline's Malarone (atovaquone and proguanil hydrochloride) Tablets, demonstrating that the malaria prevention medication has fewer adverse events overall, than the two antimalarials, mefloquine (Lariam, Roche Pharmaceuticals) and chloroquine/proguanil. According to the new prescribing information, studies show travellers taking Malarone for malaria prevention experienced significantly fewer neuropsychiatric side effects (14% vs 29%), such as strange or vivid dreams, insomnia, dizziness or vertigo, anxiety and depression, than those who took mefloquine. Additionally, fewer gastrointestinal adverse experiences, such as vomiting, nausea and diarrhoea, occurred in subjects receiving Malarone than chloroquine/proguanil (12% vs 20%). Overall, subjects receiving Malarone had fewer adverse experiences compared with travellers who used other antimalarials, mefloquine and chloroquine/proguanil. Malarone was approved by the US FDA in Jul 2000 and is indicated in adults and children for the prevention and treatment of acute, uncomplicated malaria caused by Plasmodium falciparum, including in areas of chloroquine resistance. GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies.

GlaxoSmithKline, One Franklin Plaza, Philadelphia, PA 19102, USA, Tel: +1 888
825 5249, Website: http://us.gsk.com