The US Food and Drug Administration (FDA) has issued warnings on AbbVie’s new hepatitis C treatment drugs – Viekira Pak and Technivie, saying they are capable of causing serious liver damage for patients having untreated liver disease – according to a Wall Street Journal report.
How To: Buy a Pokemon Go Plus
In the safety alert issued on Thursday, the FDA revealed it has received numerous reports of liver failure and complications in patients who have cirrhosis or scarring of the liver and still take the drugs.
The FDA disclosed that between December 2014 when Viekira Pak was approved, and July 2015, about 26 cases of liver injuries had been reported, and this was “possibly or probably” caused by the drugs. Out of the 26 reported cases, 10 patients experienced liver failure that led to their deaths or transplant surgery, and 16 suffered from various degrees of liver dysfunction.
The FDA noted that the reactions some patients experienced went away when they stopped using the drugs, and that a “temporal association” may have caused liver injuries in patients using them.
Pharmaceutical company AbbVie responded that while the drugs couldn’t be ruled out as a probable cause, no exact link has proven that they are the cause of the adverse effects experienced by the patients.
But then, they are updating the prescription labels to warn doctors and pharmacists to establish that patients do not have advanced cirrhosis or liver dysfunction before giving out the drugs. AbbVie’s vice president of pharmaceutical development, Scott Brun, noted that the patients with advanced liver scaring who should not take the drugs are 3%-5% of people suffering from hepatitis C.
About 3.2 million Americans are infected with hepatitis C, and it spreads by contact with infected blood.
Technivie was approved by the FDA in July to treat a less common type of hepatitis C. Viekira Pak costs about $83,320 to treat a patient for a 12-week treatment course, but this is discounted for insurers and others. The drug fetched $616 million in sales between January and June 2015.
"We believe that the inclusion of potential serious liver injury in the label will meaningfully commercially impair Viekira Pak sales," said Evercore ISI analyst, Mark Schoenebaum, said in an email to clients.
The shares of AbbVie fell 10% to $48.27 on Thursday after the FDA posted the safety alert.