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Pharmaceuticals / Quality / Postmarket Safety

FDA Warns of Potentially Subpotent L-Citrulline

Feb. 17, 2014

The FDA issued a safety warning Friday about a lot of L-citrulline repackaged and distributed by Medisca, after receiving reports that potentially subpotent doses have caused adverse events in some patients.

The agency says that it is also investigating adverse event reports from other lot numbers of the product and asks patients and healthcare professionals to quarantine L-citrulline from Medisca and report any problems caused by the drug.

L-citrulline is used to treat some urea cycle disorders, most of which are genetic, the agency says. If a patient with such a disorder receives subpotent L-citrulline, it can lead to dangerous and life-threatening ammonia levels.

Medisca did not respond to requests for comment by press time. View the warning at www.fdanews.com/ext/resources/files/02/02-17-14-Medisca.pdf. — Lena Freund

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