The Food and Drug Administration said it had received numerous reports of patients who either died or had to undergo liver transplantation after receiving the treatments, known as Viekira Pak and Technivie. The agency said it had identified at least 26 such cases likely related to the drugs since late 2014, and that additional cases likely exist. The liver damage usually took place within four weeks of the start of treatment, and the patients involved already had cirrhosis of the liver, the agency said.
Source
Viekira Pak, Technivie May Up Serious Liver Injury Risk: FDA
"[T]he labels now state a [contraindication] in patients with moderate to severe hepatic impairment (Child-Pugh B and C). The label previously did not recommend Viekira Pak in Child-Pugh B and was contraindicated in Child-Pugh C," according to an AbbVie statement.
Viekira Pak, Technivie May Up Serious Liver Injury Risk: FDA
"[T]he labels now state a [contraindication] in patients with moderate to severe hepatic impairment (Child-Pugh B and C). The label previously did not recommend Viekira Pak in Child-Pugh B and was contraindicated in Child-Pugh C," according to an AbbVie statement.
AbbVie's Hepatitis C Drugs Label Changed After Patient Deaths
Seven patients on AbbVie Inc.’s drugs for hepatitis C died after liver failure, prompting U.S. regulators to change their advice on how the medicine should be administered.
Doctors should monitor patients using Viekira Pak for signs of worsening liver disease, the U.S. Food and Drug Administration said in a statement Thursday.....
The Food and Drug Administration said AbbVie had identified cases of hepatic decompensation and liver failure in patients with liver cirrhosis who were taking these medicines.Doctors should monitor patients using Viekira Pak for signs of worsening liver disease, the U.S. Food and Drug Administration said in a statement Thursday.....
"Some of these events resulted in liver transplantation or death," the agency said in a posting on its website.
The FDA said it is requiring AbbVie to include warnings about the risk of serious liver injury in the labels of its combination hepatitis C treatments...
Oct 22 2015
Safety Announcement
FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie
The U.S. Food and Drug Administration (FDA) is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, we are requiring the manufacturer to add new information about this safety risk to the drug labels.
Patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury. Patients should not stop taking these medicines without first talking to their health care professionals. Stopping treatment early could result in drug resistance to other hepatitis C medicines. Health care professionals should closely monitor for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in direct bilirubin in the blood.
Viekira Pak and Technivie are used to treat chronic hepatitis C, a viral infection that can last a lifetime and lead to serious liver and other health problems, including cirrhosis, liver cancer, and death. These medicines reduce the amount of hepatitis C virus in the body by preventing it from multiplying and may slow down the disease.
Our review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to the manufacturer of these medicines, AbbVie, identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines. Some of these events resulted in liver transplantation or death. These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it.
Since the approvals of Viekira Pak in December 2014 and Technivie in July 2015, at least 26 worldwide cases submitted to FAERS were considered to be possibly or probably related to Viekira Pak or Technivie. In most of the cases, liver injury occurred within 1 to 4 weeks of starting treatment. Some of the cases occurred in patients for whom these medicines were contraindicated or not recommended (see Data Summary). FAERS includes only reports submitted to FDA, so there are likely additional cases about which we are unaware.
We are requiring AbbVie to include information about serious liver injury adverse events to theContraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.
We urge health care professionals and patients to report side effects involving Viekira Pak or Technivie to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page...
FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie
The U.S. Food and Drug Administration (FDA) is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, we are requiring the manufacturer to add new information about this safety risk to the drug labels.
Patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury. Patients should not stop taking these medicines without first talking to their health care professionals. Stopping treatment early could result in drug resistance to other hepatitis C medicines. Health care professionals should closely monitor for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in direct bilirubin in the blood.
Viekira Pak and Technivie are used to treat chronic hepatitis C, a viral infection that can last a lifetime and lead to serious liver and other health problems, including cirrhosis, liver cancer, and death. These medicines reduce the amount of hepatitis C virus in the body by preventing it from multiplying and may slow down the disease.
Our review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to the manufacturer of these medicines, AbbVie, identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines. Some of these events resulted in liver transplantation or death. These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it.
Since the approvals of Viekira Pak in December 2014 and Technivie in July 2015, at least 26 worldwide cases submitted to FAERS were considered to be possibly or probably related to Viekira Pak or Technivie. In most of the cases, liver injury occurred within 1 to 4 weeks of starting treatment. Some of the cases occurred in patients for whom these medicines were contraindicated or not recommended (see Data Summary). FAERS includes only reports submitted to FDA, so there are likely additional cases about which we are unaware.
We are requiring AbbVie to include information about serious liver injury adverse events to theContraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.
We urge health care professionals and patients to report side effects involving Viekira Pak or Technivie to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page...
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