Scientific Publications by FDA Staff

Expert Opin Drug Saf 2007 Sep;6(5):505-21

Assessment of safety of the major antimalarial drugs.

Chattopadhyay R, Mahajan B, Kumar S

Kumar S (reprint author), Ctr Biol Evaluat & Res, Div Emerging & Transfus Transmit Dis, US FDA, Rockville, MD 20895 USA Ctr Biol Evaluat & Res, Div Emerging & Transfus Transmit Dis, US FDA, Rockville, MD 20895 USA Sanaria Inc, Rockville, MD 20852 USA

Antimalarial drugs remain the major intervention tool for the global malaria control efforts that save millions of lives. Nonetheless, emergence and spread of Plasmodium parasites resistant against chloroquine and other major antimalarial drugs has brought the urgency to develop a new generation of safe and effective drugs against malaria. In this article, the safety data for major antimalarial drugs is reviewed. Although an ample amount of clinical data regarding the safety and tolerability of several of these drugs in older children and adults is available, more critical safety and tolerability studies in pregnant women and young children is desirable. To offset the partial loss in efficacy due to drug resistance in malaria parasites acquired against specific drugs, treatment regimens often rely upon the combination of two or more drugs. However, combination therapy requires additional safety, toxicity and tolerability studies in all population groups where these drugs are administered. A uniform standard in assessing the safety and tolerability of antimalarial drugs will be useful in the formulation and implementation of malaria treatment policies that are based on the drug effectiveness, safety and tolerability.