The U.S. Food and Drug Administration (FDA) issued a warning on Thursday, Oct. 22 against hepatitis C treatments known as Viekira Pak and Technivie. The agency said the drugs can result in significant liver damage, particularly in patients with existing advanced liver conditions.
The FDA said in a press release that the harmful effects of the drugs were reported to the FDA Adverse Event Reporting System (FAERS) data bank, as well as to the AbbVie, which is the maker of the drugs. Upon review, the agency was able to detect cases of liver failure and organ de-compensation among patients with existing liver cirrhosis, who were taking the drugs. Some cases have led to liver transplant and even death. The severe effects were linked mostly with Viekira Pak users, who had severe cirrhosis even prior to the treatment.
Viekira Pak was approved in December 2014 and Technivie in July 2016. Since receiving the green light, a minimum of 26 cases all around the world submitted to FAERS were said to possibly be related to Viekira Pak or Technivie.
The majority of cases involved developing liver injury in a span of one to four weeks at the onset of treatment. Some of the reports entailed patients, who took the medicines even if it were contraindicated or not recommended. "FAERS includes only reports submitted to FDA, so there are likely additional cases about which we are unaware," the press release read.
AbbVie spokeswoman Jackie Finley wrote in an email that estimates of frequency cannot be determined, as well as causal links between treatment and effects because the events that happened after marketing efforts were reported voluntarily during clinical practice.
Now, patients are urged to contact their medical professionals promptly should they experience signs and symptoms of liver damage such as weakness, fatigue, yellow eyes or skin or light-colored stools, nausea, vomiting, loss of appetite.
Patients are not advised to stop the medications until they have consulted their clinicians. Such advice was given because abruptly halting treatments may lead to drug resistance to other drugs intended for hepatitis C treatments.
Medical professionals should strictly monitor their patients for clinical manifestations of worsening liver conditions, including hepatic encephalopathy, ascites and/or elevated indirect bilirubin levels in the blood.
Viekira Pak and Technivie are indicated for the treatment of chronic hepatitis C, which is a long-term viral infection of the liver. The disease may result in severe liver impairments and other health problems such as liver cancer and death. The medicines in question work by preventing the virus from increasing and potentially decelerate the progression of the disease.
FDA now requires AbbVie to include information about the adverse effects of severe liver damage in the package inserts and drug labels.
The agency is also pushing medical professionals to report side effects that involve Viekira Pak or Technivie to the FDA MedWatch program.