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The Food and Drug Administration has issued a safety alert warning of possible serious liver injury as a result of the hepatitis C drugs Viekira Pak and Technivie, the agency announced Oct. 22.
A review of adverse events reported to manufacturer AbbVie and to the FDA MedWatch program identified serious side effects in patients with underlying liver cirrhosis, including hepatic decompensation and liver failure, the FDA said in a statement. Some of these cases resulted in liver transplantation or death, they said.
“These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it,” the statement said.
At least 26 cases submitted to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program are believed to be linked to Viekira Pak or Technivie, with most liver injuries occurring within 1-4 weeks of starting treatment, the FDA said.
Additionally, some cases “occurred in patients for whom these medicines were contraindicated or not recommended,” they said.
Viekira Pak, approved in December 2014, is a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir taken with or without ribavirin. Technivie, approved in July 2015, is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir, used in combination with ribavirin.
The FDA recommends that clinicians closely monitor patients for signs of serious liver disease such as ascites, hepatic encephalopathy, variceal hemorrhage, and increases in direct bilirubin in the blood. Additionally, it recommends that patients contact their provider immediately if they develop symptoms of liver injury such as fatigue, weakness, loss of appetite, nausea, vomiting, yellow eyes or skin, and light-colored stools.
Patients and providers can report adverse events to the FDA’s MedWatch program.
The Food and Drug Administration has issued a safety alert warning of possible serious liver injury as a result of the hepatitis C drugs Viekira Pak and Technivie, the agency announced Oct. 22.
A review of adverse events reported to manufacturer AbbVie and to the FDA MedWatch program identified serious side effects in patients with underlying liver cirrhosis, including hepatic decompensation and liver failure, the FDA said in a statement. Some of these cases resulted in liver transplantation or death, they said.
“These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it,” the statement said.
At least 26 cases submitted to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program are believed to be linked to Viekira Pak or Technivie, with most liver injuries occurring within 1-4 weeks of starting treatment, the FDA said.
Additionally, some cases “occurred in patients for whom these medicines were contraindicated or not recommended,” they said.
Viekira Pak, approved in December 2014, is a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir taken with or without ribavirin. Technivie, approved in July 2015, is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir, used in combination with ribavirin.
The FDA recommends that clinicians closely monitor patients for signs of serious liver disease such as ascites, hepatic encephalopathy, variceal hemorrhage, and increases in direct bilirubin in the blood. Additionally, it recommends that patients contact their provider immediately if they develop symptoms of liver injury such as fatigue, weakness, loss of appetite, nausea, vomiting, yellow eyes or skin, and light-colored stools.
Patients and providers can report adverse events to the FDA’s MedWatch program.
The Food and Drug Administration has issued a safety alert warning of possible serious liver injury as a result of the hepatitis C drugs Viekira Pak and Technivie, the agency announced Oct. 22.
A review of adverse events reported to manufacturer AbbVie and to the FDA MedWatch program identified serious side effects in patients with underlying liver cirrhosis, including hepatic decompensation and liver failure, the FDA said in a statement. Some of these cases resulted in liver transplantation or death, they said.
“These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it,” the statement said.
At least 26 cases submitted to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program are believed to be linked to Viekira Pak or Technivie, with most liver injuries occurring within 1-4 weeks of starting treatment, the FDA said.
Additionally, some cases “occurred in patients for whom these medicines were contraindicated or not recommended,” they said.
Viekira Pak, approved in December 2014, is a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir taken with or without ribavirin. Technivie, approved in July 2015, is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir, used in combination with ribavirin.
The FDA recommends that clinicians closely monitor patients for signs of serious liver disease such as ascites, hepatic encephalopathy, variceal hemorrhage, and increases in direct bilirubin in the blood. Additionally, it recommends that patients contact their provider immediately if they develop symptoms of liver injury such as fatigue, weakness, loss of appetite, nausea, vomiting, yellow eyes or skin, and light-colored stools.
Patients and providers can report adverse events to the FDA’s MedWatch program.
