AbbVie's Hepatitis C Drugs, Viekira Pak and Technivie, Causing Liver Damage and Hepatic Encephalopathy
Attorneys in New York City and Nationally
The Food and Drug Administration (FDA) announced that AbbVie's hepatitis C drugs, Viekira Pak and Technivie, may cause serious liver injury, even death, mostly in patients with underlying advanced liver disease. Technivie is a combination drug consisting of ombitasvir, paritaprevir, and ritonavir. Viekira Pak consists of the same three drugs as Technivie, plus dasabuvir tablets. Abbvie's hepatitis C drugs account for roughly 15% of the hepatitis C drug marketplace.
Hepatitis C is an infectious disease affecting primarily the liver, caused by the hepatitis C virus (HCV). While the infection is often asymptomatic, chronic infection can lead to scarring of the liver and ultimately to cirrhosis (permanent liver damage).
We are currently investigating claims on behalf of injured users. Our firm has over 30 years of experience handling dangerous drugs cases. If you or someone you know has suffered liver damage from Viekira Pak or Technivie the lawyers at Rheingold Giuffra Ruffo & Plotkin LLP are here to help you explore your legal options.
Liver Damage Warning Added to AbbVie's HCV Drugs
At Rheingold Giuffra Ruffo & Plotkin LLP, we take pride in helping people from New York and across the nation with their most critical legal problems. We are able to handle a wide range of dangerous drug liability claims, including those involving Viekira Pak and Technivie.
The FDA announced on October 22, 2015, that AbbVie would have to add a warning to its drug labels for the possibility of liver damage. Twenty six cases of liver complications have been reported since the drugs were approved that were likely related. Viekira Pak was approved in December 2014 and the combo drug Technivie in July 2015. The side effects were generally seen in the first four weeks.
The side effects in some cases led to liver transplantation or death. However, these serious effects were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it. You can find the full FDA warning here.
Our attorneys will work with you personally to determine the extent of your monetary damage and what legal remedies are at your disposal. Our goal is to help you obtain monetary compensation for your hardships.
Hepatic Encephalopathy caused by
Viekira Pak and Technivie
Due to the U.S. Food and Drug Administration's (FDA) recent warning of serious liver injury mostly in patients with underlying advanced liver disease using Viekira Pak and Technivie, further research has been conducted to determine other the potential side effects of the combination hepatitis-C drug. It was reported that hepatic encephalopathy can arise in both men and women using the combination therapy. Hepatic encephalopathy is the loss of brain function that occurs when a damaged liver fails to remove toxins from the blood.
Currently, the FDA has issued no warning regarding the risk of hepatic encephalopathy, as the reports are few. Researchers suspect that the drugs contained in Viekira Pak and Technivie induce some changes in the intestinal epithelium structure, thus promoting an increased absorption of ammonia. It is also theorized that the drugs, being in vitro inhibitors of P-glycoprotein, modify the BBB permeability as well, thereby reducing ammonia excretion and increasing penetration of ammonia and false neurotransmitters into the central nervous system. The BBB damage might increase ritonavir's already-observed neurotoxicity.
Although the mechanism of action is still being worked out, researchers warn that more testing must be done to determine optimal management of these new hepatitis-C therapies.