FDA flags serious risks with hepatitis C drugs from AbbVie, Gilead and Merck

FDA flags serious risks with hepatitis C drugs from AbbVie, Gilead and Merck

The U.S. Food and Drug Administration said on Wednesday it had identified 63 cases of worsening liver function in certain patients taking hepatitis C medicines made by drugmakers Merck & Co Inc, Gilead Sciences and AbbVie Inc.

FILE PHOTO: The headquarters of the U.S. Food and Drug Administration is shown in Silver Spring nea
FILE PHOTO: The headquarters of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. REUTERS/Jason Reed/File Photo

REUTERS: The U.S. Food and Drug Administration said on Wednesday it had identified 63 cases of worsening liver function in certain patients taking hepatitis C medicines made by drugmakers Merck & Co Inc, Gilead Sciences and AbbVie Inc.

The agency said that while the treatments are safe and effective, it had received reports of rare but serious instances of worsening liver function or failure when these drugs were taken by patients with advanced liver disease. (https://reut.rs/2Zu2xoN)

These medicines are not indicated for use in patients with moderate to severe liver impairment, but are safe and effective in patients with no or mild liver impairment, the FDA said.

The companies did not immediately respond to Reuters requests for comment.

(Reporting by Tamara Mathias in Bengaluru; Editing by Shailesh Kuber)

Source: Reuters

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