AFX News
(c) 2002 by AFP-Extel News Ltd
Thursday, August 22, 2002
GlaxoSmithKline's Malarone new safety data approved by US FDA

PHILADELPHIA (AFX) - GlaxoSmithKline PLC said the US Food and Drug
Administration has approved the addition of new safety data to the
prescribing information of the company's Malarone tablets for the
treatment of malaria.

The additional safety information indicates that Malarone has fewer
adverse events overall, than the two anti-malarial medications --
mefloquine and chloroquine/proguanil.

The new data cited studies showing travelers taking Malarone for
malaria prevention experienced significantly fewer neuropsychiatric side
effects 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 diarrhea, occurred in subjects receiving Malarone
than chloroquine/proguanil, the statement said.

Malarone was approved by the FDA in July 2000 and is indicated in
adults and children for the prevention and treatment of acute and
uncomplicated malaria.