FDA fires off a warning on rare cases involving death, adverse liver events linked to misuse of 3 big hep C drugs
Just as one probably errant drug safety rumor was being debunked at Vertex, the FDA triggered a real alarm on a trio of prominent hep C drugs now linked with a lethal liver reaction.
AbbVie’s Mavyret, Merck’s now deeply discounted drug Zepatier and Gilead’s Vosevi were involved in 63 cases of liver decompensation — incidents of liver dysfunction — which includes some deaths, according to the FDA. Most suffered from significant liver impairment and should never have been prescribed the drug to begin with. And the agency wants to find out if there are more.
This number includes only cases submitted to FDA or those found in the medical literature, so there may be additional cases about which we are unaware (see Data Summary). In 2018, an estimated 72,000 patients received dispensed prescriptions for Mavyret, Zepatier, or Vosevi from U.S. outpatient retail and mail-order/specialty pharmacies.
The agency gathered the reports from its FAERS database, where doctors are asked to submit reports on drug safety. A useful tool for defining safety threats in the drug supply, the FDA opened up access two years ago, laying the groundwork for some market gambits on Wall Street.