The FDA has issued a safety communication regarding Viekira Pak and Technivie, which are hepatitis C treatments manufactured by AbbVie.
Here are five key notes:
1. According to FDA warning, Viekira Pak and Technivie can cause serious liver injury, mostly in patients with underlying advanced liver disease.
2. The FDA required the manufacturer to add information about this safety risk to the drug labels. AbbVie updated the labels "from 'not recommended in Child-Pugh B patients' to a contraindication in patients with Child-Pugh B cirrhosis. Patients classified as Child-Pugh C will remain contraindicated as they have been since approval."
3. The FDA reviewed adverse events reported to the FDA Adverse Event Reporting System database and to AbbVie. They found cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines — with some cased resulting in liver transplantation or death.
4. The FDA urges patients taking these medicines to contact their healthcare professionals immediately if they develop symptoms, such as fatigue, weakness, loss of appetite, nausea and vomiting.
5. Additionally, the FDA urges healthcare professionals to closely monitor for signs and symptoms of worsening liver disease.