Responding to numerous reports of patients who had either died or had to undergo a liver transplant after receiving two hepatitis C medications, the U.S. Food and Drug Administration (FDA) issued a warning that the drugs can cause serious liver injury in patients with advanced forms of liver disease. The damage was said to have occurred within four weeks of the start of treatment, and the patients affected already had cirrhosis of the liver, according to the FDA.
AbbVie Required to Add Warnings to Labels
The FDA plans to require drug maker AbbVie to add new warnings to the safety labels of the mediations, Viekira Pak and Technivie, directed toward patients who already have advanced liver disease linked to hepatitis C. The agency also urged doctors to closely monitor patients taking the drugs for symptoms of worsening liver death, and to advise patients to seek medical care immediately if they develop:
- Loss of appetite
- Other signs of liver injury
New Hepatitis C Drugs Effective But Pricey
Both Viekira Pak and Technivie were approved by the FDA and introduced to the market during the past year. The medications are among several new treatments for hepatitis C that have drawn attention not only for their effectiveness, but also for their high cost, which can exceed $80,00 per patient. However, in the wake of the FDA announcement, AbbVie’s stock reportedly fell more than 10 percent.
According to the Centers for Disease Control and Prevention (CDC), nearly 3 million Americans have the hepatitis C virus, which if left untreated can result in long-term health problems, including liver damage, liver failure, liver cancer, and even death. An estimated 15,000 people in the U.S. die from the disease each year.