Viekira Pak lawsuits may be emerging in the coming months after the FDA issued their strictest warning yet for this life-saving medication. On October 4, 2016, the FDA issued a Black Box Warning for Viekira Pak and 8 other direct acting antiviral medications that are used to treat Hepatitis C. The warning stated that these medications increased the risk of reactivating the Hepatitis B Virus (HBV) in many patients. Patients who have taken Viekira to treat Hepatitis C, but who have seen a reactivation of their Hepatitis B and subsequently experienced liver damage or liver failure, should contact an experienced Viekira lawsuit attorney immediately to review their case.
What is Hepatitis C?
Hepatitis C is a contagious liver disease that if left untreated can lead to liver failure and even death. It is most commonly spread through exposure to diseased blood, like sharing contaminated needles, needle sticks in the healthcare setting, or blood transfusions. It is estimated that more than 3.8 million Americans suffer from chronic Hepatitis C.
Until recently, Hepatitis C medications could only control the spread of the virus in a patient’s body. In 2014, however, all of that changed when direct acting antiviral (DAA) medications were approved by the FDA. These medications had a 90% cure rate for Hepatitis C and were immediately embraced by the medical community despite their hefty price tags. One 12-week treatment course can cost up to $100,000.
What is Viekira Pak?
Viekira Pak is a multi-pill, antiviral that is used to prevent Hepatitis C virus from multiplying in a patient’s body. It has relatively few side effects and like other DAA medications, can effectively cure Hepatitis C in up to 90% of all patients. Viekira Pak and Viekira Pak XR are manufactured by AbbVie Inc.
Until now, there were few side effects or adverse reactions associated with Viekira Pak. Now, however, it has been issued a Black Box Warning. The FDA warned that Viekira Pak, along with 8 other DAA medications could cause the reactivation of HBV in many patients. Patients who had previously been diagnosed with HBV but whose HBV was dormant, could see a reactivation and sudden emergence of the virus shortly after taking Viekira Pak to treat Hepatitis C.
Complications of reactivation of HBV include liver failure, cirrhosis, liver cancer, and death. Patients who experience sudden nausea and vomiting, light colored stools, yellow eyes, yellow skin, jaundice, fatigue and weakness should contact their health care provider immediately.
The FDA also urged all healthcare providers and physicians to begin screening for HBV prior to beginning DAA treatment on chronic Hepatitis C patients. If a patient does have a history of HBV, physicians should monitor that patient carefully during and after treatment for signs of liver failure.
Viekira Pak isn’t the only DAA that received the FDA strict Black Box Warning. Many therapies from multiple drug manufacturers were also covered in the black box warning list, including:
- Sovaldi from Gilead Sciences
- Harvoni from Gilead Sciences
- Epclusa from Gilead Sciences
- Technivie from AbbVie Inc
- Viekira Pak & Viekira Pak XR from AbbVie Inc
- Daklinza from Bristol-Myers Squibb
- Xepatier from Merck Sharp Dohme
- And Olysio from Johnson & Johnson & Janssen
Viekira Pak Case Evaluations
If you suffered a recurrence of Hepatitis B as a result of taking a Hepatitis C medication, such as such as Sovaldi, Harvoni, or Viekira Pak, you may be eligible for financial compensation. To learn more about Viekira Pak Lawsuits and to discover if you or your loved one may be eligible, contact us immediately. For a free case evaluation, please complete the form on this page or call us today.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.