FDA approves Intravenous Artesunate, the first drug for seve
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U.S. Food and Drug Administration approved the artesunate for injection to treat severe malaria in adult and pediatric patients.

• "Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen", say FDA.

• The safety and efficacy of IV artesunate for the treatment of severe malaria were primarily evaluated in a randomized controlled trial in Asia (Trial 1) and a supportive published randomized controlled trial in Africa (Trial 2).

• In Trial 1, the most common adverse reactions in patients with malaria treated with IV artesunate were acute renal failure requiring dialysis, hemoglobinuria, and jaundice. The safety profile in Trial 2 was generally similar to Trial 1.

• Artesunate should not be used in patients with a known serious allergy to artesunate such as anaphylaxis.

• The FDA granted approval of the artesunate for injection to Amivas.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-form-bladder-dysfunction-pediatric-patients-young-2-years-age
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Dr. S●●●●●m S●●●●y P●●●●●l
Dr. S●●●●●m S●●●●y P●●●●●l General Medicine
The obvious question is,if US FDA says that appropriate oral regimen must follow iv artesunate,what is the role of this new drug and which drugs must follow its course?
May 27, 2020Like1