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Drug-induced Injuries from HARVONI, SOVALDI, and VIEKIRA PAK

November 30, 2017 · FLEMING | NOLEN | JEZ, L.L.P.

Hepatitis is a viral infection that causes inflammation of the liver and can persist for decades without symptoms. At least 2 to 4 million people are thought to have Hepatitis C (HCV).  The virus is transmitted from person to person and is a blood borne disease.  Many veterans were exposed to the virus during mass military AIRGUN vaccinations; others were exposed through transfusions or needle sticks. The risk of developing Hep C End Stage Liver Disease is considered low for the first three decades of infection.

These antiviral drugs have been touted as having high cure rates. However, the clinical studies have not been released completely for scientific review to identify their safety and efficacy. Also, there are no long-term randomized controlled trials of any antiviral treatment for Hepatitis C that evaluates clinical outcomes like cirrhosis, liver failure, liver cancer, need for organ transplantation or death.

In March 2015, the FDA announced a labeling change for the antivirals HARVONI (ledipasvir-sofosbuvir) and SOVALDI (sofosbuvir) manufactured by Gilead Sciences, after Gilead reported “bradycardia, pacemaker intervention, and even death in patients who took the medications along with amiodarone.”  The deaths occurred within 24 hours of taking both drugs.

In October 2016, the FDA identified the first major safety problem caused by the antiviral drugs. In some patients, the drugs wiped out Hep C — but reactivated Hepatitis B infections that were dormant, leading to liver failure and death.

In the same year the FDA released a safety warning, that the use of VIEKIRA PAK (AbbVie) can cause serious liver injury resulting in liver transplantation or death.

Two years after going on the market a Black Box warning for Hepatitis B virus reactivation appeared in 2017 on both the HARVONI & SOVALDI labels.

The FDA adverse event reporting system has shown numerous reports of sudden death, respiratory failure, renal failure, cardiac failure, hepatic failure, as well as other serious problems all related to Hep C treatments.

If you or a loved one has taken HARVONI (ledipasvir-sofosbuvir), SOVALDI (sofosbuvir) or VIEKIRA PAK and has experienced drug induced injuries, signs of liver failure, kidney failure, other organ failure, or death, please allow our legal team to examine the specifics of your case. Call our firm at (866) 977-6671, or fill out our online form to start out with a free consultation.