FDA requiring direct-acting antiviral manufacturers to put 'black box' warnings on labels: 4 thoughts

The FDA is requiring manufacturers to put 'black box' warnings on labels of direct-acting antiviral prescriptions because of the possibility that the drugs cause the hepatitis B virus to resurface, Gastroenterology and Endoscopy News reports.

Here's what you need to know.

1. The FDA has received 24 reports of HBV reactivating between Nov. 22, 2013 to July 18, 2016. After starting therapy with the DAA drugs, physicians reported reactivations four to eight weeks later.

2. Out of the 24 reports, two patients died and another needed a liver transplant.

3. There may be more reported cases because HBV-coinfected patients were excluded from trials for DAA approvals. HBV reactivation was not reported as adverse.

4. The FDA is encouraging physicians to screen all patients with current or prior HBV infection and to watch for possible symptoms.

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