New Black Box Warnings Spur Lawsuits
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 Medications Have Been Affected by FDA Black Box Warning
To date, the following DAA medications were part of the FDA Black Box Warning:
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
Note: These statements have not been evaluated by the FDA.
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