The FDA Issues a Drug Safety Communication Warning of Liver Failure, Damage, and Injury Caused by Hepatitis C Medicines – Mavyret, Zepatier, and Vosevi. (08/28/2019) WASHINGTON, D.C. — On August 28, 2019, the FDA released a “Drug Safety Communication” stating that prescription medications containing a hepatitis C virus (“HCV”) protease inhibitor could lead to severe […]
Hepatitis C drugs
(08/28/2019) WASHINGTON, D.C. — On August 28, 2019, the FDA released a “Drug Safety Communication” stating that prescription medications containing a hepatitis C virus (“HCV”) protease inhibitor could lead to severe liver injuries. According to the U.S. Food and Drug Administration’s website, the FDA has been receiving numerous reports of liver failure caused by the use of the Hepatitis C drugs Mavyret, Zepatier, and Vosevi through the FDA’s Adverse Event Reporting System (FAERS). The FDA Drug Safety Communication affirmed over 60 cases of decreased liver function, also known as liver decompensation, in patients who were taking Mavyret, Vosevi, and Zepatier. Of these cases, some patients suffered liver failure and died.
The FDA Drug Safety Communication reported that medications containing HCV protease inhibitors are not recommended for use in treatment plans in HCV patients who have “moderate to severe” liver damage or diminished function. The FDA reported that the worsening of liver function did stop in most patients who stopped taking the prescription hepatitis C drugs Mavyret, Vosevi, or Zepatier. Also, the FDA stated that these hepatitis C prescription drugs are popular, safe, and effective for hepatitis C virus patients who have no to mild liver damage or impairment.
Hepatitis C is a dangerous and contagious disease that leads to liver failure, liver cancer, cirrhosis of the liver, and/or death if left untreated. Mavyret, Vosevi, and Zepatier are HCV medications that are approved by the FDA to treat patients with hepatitis C and who are diagnosed with none to minor liver impairment (also known as Child-Pugh A). Previous clinical trials have shown these drugs to be very effective and well-tolerated in patients with “compensated cirrhosis or Child-Pugh A.” These medications work by helping the body to reduce HCV and by assisting the body to prevent the HCV from multiplying. By reducing the amount of hepatitis C virus in the body and eventually clearing the virus from a patient’s body, the patient’s liver may be protected from further damage or diminished function.
According to the FDA, hepatitis C patients with a liver impairment rating of moderate to severe, should not have been prescribed Mavyret, Vosevi, or Zepatier. The FDA estimates that over 72,000 patients have been prescribed Mavyret, Zepatier, or Vosevi in 2018 and that the number of liver injury cases reported its Adverse Event Reporting System would increase.
If you or a loved one were prescribed Mavyret, Zepatier, or Vosevi and suffered liver failure, speak with your doctor and then call Parker Waichman LLP at 1-800-YOURLAWYER (1-800-968-7529) for your free case evaluation. You or your loved one could qualify to recover significant monetary compensation.
