Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis (2020) / Chapter Skim
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1 Introduction
1 Introduction
Pages 17-24
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From page 17... ...
The use of malaria prevention methods such as dermal mosquito repellents, chemical-repellentimpregnated clothing, and bed nets can help reduce the risk, but they are not as effective as prophylactic drugs. A variety of malaria-preventing drugs have been discovered since quinine was first isolated from the bark of the cinchona tree in the early 1800s, and several are in widespread use today.
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From page 18... ...
Given its mission and in response to these concerns, VA contracted with the National Academies of Sciences, Engineering, and Medicine (the National Academies) to convene an expert ad hoc committee to conduct an assessment of the scientific evidence regarding the potential for long-term health effects resulting from the use of any of the currently available antimalarial drugs that were approved by FDA and/or used by U.S.
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From page 19... ...
Based on the contract between VA and the National Academies and as specified in the committee's Statement of Task, this report includes the following antimalarial drugs that are used as prophylaxis, have been approved by FDA or used by U.S. military personnel, and are currently available or have been used in the recent past: efloquine (Lariam®)
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From page 20... ...
Instead of recommendations, the committee was asked to offer conclusions based on available evidence regarding the long-term effects and to provide observations on the best use of available data as well as considerations for future research in examining the persistent or latent health effects of antimalarial drugs. Given the difficulty of conducting strict causality assessments, the committee chose instead to base its assessment on measures of association between exposure to an antimalarial drug and health outcomes.
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From page 21... ...
This process was supplemented by examining other pertinent published literature, government documents and reports, and testimony and by consulting relevant National Academies reports. As is the practice of nearly all National Academies consensus committees, the committee held two open sessions not only to gather additional information from people who have particular expertise on topics and subjects that arise during deliberations (such as experts in toxicology, agency representatives who are familiar with antimalarials policy and changes to it, and those who monitor reports of adverse events through postmarketing surveillance)
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From page 22... ...
Each drug-specific chapter begins with a brief history of the drug's development and use followed by a summary of the changes that have been made to the drug package insert or label since its approval as a prophylactic drug for malaria and then its pharmacokinetic properties. Known short-term adverse events associated with the use of the drug are then reported, followed by a summary and assessment of each of the identified epidemiologic studies that met the committee's inclusion criteria and were able to contribute some information on long-term health outcomes following cessation of the drug.
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From page 23... ...
The committee discusses research considerations or approaches that can be implemented to improve the quality of data collected as well as the overall evidence base. Appendix A provides a list of open meeting agendas and invited presentation topics and Appendix B summarizes the invited presentations to the committee.
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