Hepatitis C lawsuits may be emerging soon after the FDA issued a Black Box Warning for 9 direct acting antiviral (DAA) medications this October 2016. Patients who have taken DAA medications and seen a reemergence of their Hepatitis B, experienced liver damage, or suffered liver failure, may be eligible to file a lawsuit against the drug manufacturers. According to the FDA, this reactivation usually occurred within 4-8 weeks of receiving DAA treatment drugs. During clinical trials, this potentially deadly side effect was not discovered because researchers only recruited patient with Hepatitis C and no co-infections.
What is Chronic Hepatitis C?
Chronic Hepatitis C is a contagious liver disease that affects nearly 4 million Americans in the United States. People can become infected with the Hepatitis C virus due to sharing infected needles, needle sticks in the healthcare setting, or being born to a mother with Hepatitis C. Before 1992, it was most commonly contracted through blood transfusions and organ transplants. Of every 100 people infected with the Hepatitis C virus, 70% will develop chronic liver disease, 20% will develop cirrhosis, and up to 10% will die. In 2014, however, all of that changed with the emergence of direct-acting antiviral (DAA) drugs.
Before 2014, chronic Hepatitis C patients could take medications to manage their condition. These medications would not cure the disease, but they would reduce the amount of the virus in the patient’s body, thereby reducing the complications. DAA drugs, however, can effectively wipe out the Hepatitis C virus – providing a true cure. In fact, it is estimated that DAA drugs have a 90% cure rate and newer treatment drugs can even treat less common strains in a shorter amount of time. Until now, the only major drawback to these lifesaving medications has always been the cost. One 12-week treatment course can cost up to $100,000.
Now, however, there is a new concern regarding DAA drugs. On Tuesday, October 4, 2016, the FDA announced that it would require manufacturers of certain DAA drugs to place a black box warning on the label warning. This warning states that these drugs could reactivate the dormant Hepatitis B virus (HBV) in people who were infected with both. Of the 24 cases that were previously reported to the FDA, two patients required liver transplants and one patient died as a result.
What Medications Have Been Affected by FDA Black Box Warning
To date, the following DAA medications were part of the FDA Black Box Warning:
- Viekira Pak
- Viekira Pak XR
Patients who have Hepatitis C and are considering DAA drug treatment should notify their doctor if they have also been previously diagnosed with HBV. Doctors should also screen patients for HBV prior to starting Hepatitis C drug treatment and they should monitor HBV patients closely for signs of liver failure, liver damage, or adverse reactions.
Signs of Hepatitis B (HBV) Reemergence
Patients who have signs of liver damage or liver failure should notify their physician immediately. Some of those signs include:
- Yellow eyes and skin
- Fatigue or weakness
- Loss of Appetite
- Light colored stools
If you suffered a recurrence of Hepatitis B as a result of taking a Hepatitis C medication, such as such as Sovaldi, Harvoni, or Viekira Pak, you may be eligible for financial compensation. To learn more about Hepatitis B Lawsuits and to discover if you or your loved one may be eligible, contact us immediately. For a free case evaluation, please complete the form on this page or call us today.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.