FDA Issues Most Severe Warning Over New Hep C Drugs
Serious liver problems or death have occurred for some patients taking the treatment.
The Wall Street Journal:
FDA Warns On Hepatitis C Drugs
The Food and Drug Administration is warning about the risk of reactivation of hepatitis B among patients who have had that disease and who are taking some prominent and expensive newer medicines for hepatitis C. The federal agency said it is requiring a so-called black-box warning in the labels for at least nine brand-name direct-acting antiviral drugs, including Sovaldi and Harvoni from Gilead Sciences Inc., Viekira Pak from AbbVie Inc. and Zepatier from Merck & Co. (Burton, 10/4)
In other news about the FDA —
The Wall Street Journal:
Group Calls For More Steps To Curb Use Of Antibiotics In Livestock
U.S. food regulators need to take further steps to curb antibiotics use in livestock to maintain the drugs’ ability to defend human health, according to an advocacy group. By early next year, animal drugmakers have agreed to abide by U.S. Food and Drug Administration guidelines to stop using antibiotics used in human medicine to help livestock and poultry gain weight faster. Some antibiotics had been used for that purpose on farms for decades, alongside treating and preventing disease. (Bunge, 10/4)
