FDA warns that certain hepatitis C drugs can have serious side-effects

pharmafile | October 5, 2016 | News story | Medical Communications, Research and Development FDA, hepatitis B, hepatitis C 

The FDA has issued a warning to patients who are currently taking drugs to treat hepatitis C that they may be at risk of reactivation of hepatitis B, to those who have previously had the virus. The FDA has ordered ‘black-box’ warning on the labels for the treatments. These prominent warnings are the most drastic label warning that can be ordered by the FDA, reflecting the serious potential risks posed by the reactivation of hepatitis B.

“We identified 24 cases of hepatitis B reactivation reported to FDA and from the published literature in hepatitis B/ hepatitis C co-infected patients treated with direct-acting antivirals during the 31 months from November 22, 2013 to July 18, 2016,” the FDA said in a statement.

“This number includes only cases submitted to FDA, so there are likely additional cases about which we are unaware. Of the cases reported, two patients died and one required a liver transplant,” it added.

Hepatitis C affects around 130-150 million people around the globe, with 3.2 million affected in the US. The risks of the virus can be severe, with potential for illnesses such as cirrhosis and liver cancer to arise. The expense of treating the illness can range from $54,000 to as high as $94,000, an expense which is putting pressure on the budgets of insurance firms. The efficacies of the drugs, however, are without question – they boast a cure rate of 90% and above.

The FDA has recommended health care professional to screen all patients for evidence of current or prior hepatitis B infection before starting treatment with direct-acting antivirals used to treat hepatitis C, and then monitor patients using blood tests for potential hepatitis B flare-ups.

Ben Hargreaves

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