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FDA Warns Hepatitis C Treatments May Cause Serious Liver Injury

Posted by Sarah Showard | Mar 27, 2016 | 0 Comments

FDA Warns Hepatitis C Treatments May Cause Serious Liver Injury

The Food and Drug Administration (FDA) is warning consumers that patients with underlying advanced liver disease risk serious liver injury by using two hepatitis C treatments -- Viekira Pak and Technivie -- manufactured by AbbVie.

Both of the AbbVie drugs are used to treat chronic hepatitis C, a condition caused by a viral infection that can cause liver cirrhosis, cancer and even death. The AbbVie medications work to slow the multiplication of hepatitis C virus in the body.

The FDA said that adverse event reports submitted to the agency and to the manufacturer showed that some patients with underlying advanced liver disease suffered liver failure and hepatic decompensation as a result of taking these medications. Some of the incidences reported resulted in liver transplantation or death.

Viekira Pak was approved in December 2014 and Technivie received approval in July 2015. Since those approvals, the FDA has received at least 26 worldwide reports of liver injury due to the medications, which typically occurred 1-4 weeks after beginning treatment. Of the 26 cases reported, 10 patients either required a liver transplant or died; 16 patients experienced liver dysfunction.

The FDA has ordered AbbVie to include information about these serious liver injury risks on drug labels for Viekira Pak and Technivie. AbbVie said that package inserts for the drugs have been changed to note they should not be prescribed for patients with advanced liver disease caused by hepatitis. AbbVie is also recommending that physicians screen patients for evidence of liver decompensation before and during treatment.

Before taking Viekira Pak or Technivie, patients should tell their doctors if they have liver problems other than hepatitis C, have been diagnosed with HIV or are taking birth control medication that contains ethinyl estradiol.

"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," the FDA said.

Showard Law Firm is Tucson's local law firm for defective drug and medical device claims.  If you believe you or a loved one have been harmed by a medication, contact us for a free consultation.

About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Women's Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorney, and has been representing plaintiffs since 1990. Sarah has a son, Benjamin, who recently graduated from The Gregory School and will attend ASU in the fall, with future plans to attend law school and eventually join Showard Law Firm. In her spare time Sarah enjoys horseback riding and spending time in Sonoita with her husband Peter.

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Showard Law Firm is dedicated to compassionate representation for our clients who have been injured by defective products, dangerous drugs or the negligence of any individual or company. We are experienced in litigation and ready to ensure you receive the maximum possible settlement for your injuries, medical bills, mental anguish and other losses.

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2016 marked the 10th anniversary of Showard Law Firm. After 18 years of practice, and a prior ten-year partnership, Sarah Showard and her longtime assistant, Maria De La Rosa, opened the doors of Showard Law Firm in October 2006. Sarah and everyone at Showard Law Firm is proud to serve Southern Arizona as the local law firm for defective drug and medical device claims and personal injury.