FDA Has Warned that Viekira Pak, Technivie Hepatitis C Therapies Have Been Linked to Serious Liver Injuries in Certain Patients, Some Resulting in Need for Liver Transplantation and Death
Southern Med Law announces the launch of a new Viekira Pak liver injury lawsuit page, which can now be viewed at the Firm’s website, www.southernmedlaw.com. The Viekira Pak liver injury lawsuit attorneys at Southern Med Law created this page in response to a recent warning from the U.S. Food & Drug Administration (FDA) regarding reports of serious liver injuries in certain patients being treated with Viekira Pak and Technivie hepatitis C therapies. The Firm’s new page is intended to provide alleged victims of Viekira Pak and Technivie liver injuries with important information about their legal rights.[fda.gov/Drugs/DrugSafety/ucm468634.htm, FDA, October 26, 2015]
Viekira Pak is a hepatitis C treatment that was approved by the FDA in 2014, and is indicated for patients with genotype 1 chronic hepatitis C infections, including those with compensated cirrhosis. Technivie was launched in July 2015 and is approved for patients with genotype 4 chronic hepatitis C virus infection without cirrhosis. Both medications are marketed by AbbVie, Inc. While no data is yet available for Technivie, the FDA estimates that 10,104 patients in the U.S. filled prescriptions for Viekira Pak between December 2014 and August 2015.
In October 2015, the FDA announced that AbbVie would be adding new information to the Viekira Pak and Technivie labels regarding serious liver injuries in patients with underlying advanced liver disease. According to the agency, 26 cases of liver failure and hepatic decompensation possibly or probably related to the use of these treatments were reported to the FDA’s Adverse Event Reporting System between December 2014 and July 2015. Ten of the incidents involved liver failure resulting in transplantation or death, while 16 resulted in various degrees of liver dysfunction. In most of the cases, liver injury occurred within 1 to 4 weeks of starting treatment. Serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before treatment was initiated.
The FDA has advised Viekira Pak and Technivie patients to contact their doctor immediately if they develop signs of serious liver injury, including:
• Loss of appetite
• Nausea and vomiting
• Yellow eyes or skin
• Light-colored stools
Dr. François Blaudeau and his colleagues are now offering free legal reviews to alleged victims of Viekira Pak or Technivie liver injuries. To obtain a free, no obligation Viekira Pak liver injury lawsuit review, please visit www.southernmedlaw.com, or call the office directly at 205-547-5525.
About Southern Med Law and Filing a Viekira Liver Injury Lawsuit: Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made the Southern Med Law team an aggressive and effective advocate for those who were harmed due to negligent medical device manufacturers. If your baby was harmed by the Viekira Pak or Technivie, please contact Southern Med Law today to learn more about your legal rights. Call today for a free, no-obligation Viekira Pak lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203