FDA Advises On Potential For Viekira Pak Liver Injuries

   

Reports of Viekira Pak Liver Injuries And Technivie Hepatitis C Treatment Injuries Have Resulted Liver Transplants And Even Death.

viekira-pak-liver-injuries-technivie-liver-injuries-lawsuit-lawyer-attorneyThe U.S. Food and Drug Administration (FDA) warns that Viekira Pak hepatitis C treatments and Technivie Treatments can cause serious liver injury or death, primarily to patients who have an underlying advanced liver disease. The federal regulatory agency is requiring AbbVie, the company that manufactures both medications, to add this new Viekira Pak liver injuries warning to the drug labels of Viekira Pak and Technivie.

The FDA recommends patients to contact their doctors immediately if they develop signs of liver injury that include:

  • Fatigue
  • Weakness
  • Appetite loss
  • Nausea and vomiting
  • Yellow eyes or skin
  • Light-colored stools

The agency does not recommend patients stop taking Viekira Pak or Technivie before visiting their doctors. The FDA also advised health care providers to watch for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in direct bilirubin in the blood.
[fda.gov/drugs/drugsafety/ucm468634.htm, FDA, October 22, 2015]

“Patients who sustained serious liver injuries allegedly from taking Viekira Pak or Technivie may be entitled to compensation from the manufacturer,” says Dr. François Blaudeau, founder of Southern Med Law.

The Firm has been investigating patient claims on Viekira Pak and is now offering legal evaluations to individuals and their families who believe they have suffered hepatic decompensation, liver failure and other related injuries allegedly from using Viekira Pak or Technivie. If you are interested in pursuing a Viekira Pak or Technivie lawsuit on behalf of yourself or a loved one, please contact Southern Med Law by visiting www.southernmedlaw.com, or call the office directly at 205-547-5525 today.

Viekira Pak was approved by the FDA in 2014 to treat patients with genotype 1 chronic hepatitis C infections, including those with compensated cirrhosis. Technivie received the agency’s approval in July 2015 for use in patients with genotype 4 chronic hepatitis C virus infection without cirrhosis. Viekira Pak and Technivie reduces the amount of hepatitis C virus in the body by preventing it from multiplying and may slow down the disease, according to the FDA. Chronic hepatitis C is a viral infection that can last a lifetime and lead to such health problems as cirrhosis. From December 2014 through August 2015, an estimated 10,104 patients in the United States have been prescribed Viekira Pak, according to the FDA. The accurate number of prescriptions for Technivie is not available due to its recent approval in July.

The FDA issued the warning over Viekira Pak and Technivie after receiving reports of 26 worldwide cases of liver injury that were probably related to the two hepatitis C treatment medications. Of the total number of cases, 10 patients experienced hepatic failure resulting in transplantation or death, and 16 patients experienced various degrees of liver dysfunction. Liver injury occurred within one to four weeks of the patients starting treatment in most of the cases.

In reviewing adverse events reported to AbbVie and the FDA Adverse Event Reporting System (FAERS) database between December 2014 and July 2015, the FDA said it identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking Viekira Pak and Technivie. Serious outcomes were reported mostly in patients taking Viekira Pak who had advanced cirrhosis even before starting treatment with it. Since the FAERS only includes reports submitted to the FDA , the agency says there may be other liver injury cases about which it is not aware.

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 you or your loved one was harmed by 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
Phone: 205-547-5525

Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com

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