Hepatitis C Drugs Whose Prices Drew Criticism Get FDA Warning

(Bloomberg) -- Drugs that treat hepatitis C, whose high prices have previously sparked outrage, can in rare instances cause liver failure and other complications, the U.S. Food and Drug Administration said.

The FDA said it had received reports that drugs made by Gilead Sciences Inc., AbbVie Inc. and Merck & Co. can in some cases lead to worsening liver function in patients who already had moderate or severe liver damage, according to a statement Wednesday. The agency said the drugs remain safe for patients with mild liver disease.

Shares in all three companies were little changed following the news. Requests for comment from company representatives weren’t immediately returned.

Hepatitis C is a virus that slowly leads to liver damage and even failure when left untreated. A new class of drugs introduced several years ago cures patients of the illness, a breakthrough that was heralded by doctors and public health officials. But the drugs also set off a national controversy around their unprecedented high price tags. The therapies remain among the best-selling drugs of all time.

Merck’s medicine, Zepatier, was among the drugs cited for liver risk from the FDA. The company last year said it would lower the price of that drug to $260 a pill from $650 a pill, according to data compiled by Bloomberg Intelligence, after pressure from the Trump administration. Zepatier, however, has struggled to compete with rival therapies.

To contact the reporters on this story: Rebecca Spalding in Boston at rspalding@bloomberg.net;Anna Edney in Washington at aedney@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Mark Schoifet

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