On Aug. 28, 2019, the United States Food and Drug Administration issued a statement regarding medicine used to treat hepatitis C. The FDA hepatitis medication announcement described the rare potential of certain drugs being poorly prescribed, resulting in liver damage and failures.
Interpreting The FDA Hepatitis Medication Announcement
The FDA hepatitis medication announcement described how hepatitis C medications Mavyret, Zepatier, or Vosevi have resulted in 63 cases of worsening liver function or liver failure in patients. These medicines contain a hepatitis C virus (HCV) protease inhibitor and are not indicated for use in patients with moderate to severe liver impairment. According to the FDA, however, some doctors may have prescribed the medications against official recommendations.
The symptoms that some patients experienced were resolved and liver function improved after stopping the medicine in certain patients. According to the FDA hepatitis medication announcement, liver failure occurred in patients who had signs and symptoms of Child-Pugh class B or C, implying moderate to severe existing liver risks. In some cases, patients were reported as having a Child-Pugh class A liver risk despite existing evidence of liver damage such as decreased platelets at baseline or increased pressure within the portal vein that carries blood from the digestive organs to the liver.
Additionally, the FDA hepatitis medication announcement states that several patients also had significant pre-existing risk factors for liver damage such as liver cancer, alcohol abuse, or serious illnesses associated with liver problems. These factors have been suggested as reasons for the liver decompensation in conjunction with the hepatitis medications.
Liver failure or damage has been reported within the first 4 weeks of starting treatment according to the FDA but they have recommended that physicians and health care professionals continue medication of Mavyret, Vosevi, and Zepatier in patients as long as they assess the risks of liver damage and pre-existing risk factors in patients. The FDA has reaffirmed in their announcement that Mavyret and Zepatier should not be prescribed in patients with a history of prior hepatic decompensation.
Patients have been cautioned in the FDA hepatitis medication announcement that the risk of serious liver injury is professed to be rare. Additionally, patients are advised to contact a physician if they develop any of the following symptoms:
- Loss of appetite
- Yellowing of the eyes or skin
- Light-colored stools
- Increases in liver enzymes
- Variceal hemorrhage
These symptoms have been named as indicative of liver decompensation. Despite the risk of complications, the FDA hepatitis medication announcement also stressed patients should not
stop taking their medication without a physician’s order.
Healthcare professionals and their patients have also been called to report side effects or harmful events as a result of the use of Mavyret, Zepatier, or Vosevi using the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
For more information about the risks and dangers of doctors prescribing medication poorly, visit Parker Waichman’s Medical Malpractice Lawsuit Page.
How The FDA Hepatitis Medication Announcement Affects Your Compensation
While the FDA is now taking action and continuing to research the dangers of these medications and the potential wrongful prescription by doctors to protect consumers, the research has not been completed. Many patients have suffered side effects as a result of liver complications. If you or a loved one have been affected by liver complications as a result of using Mavyret, Vosevi, or Zepatier, you may be eligible for financial compensation. If you pursue this compensation you will need top legal representation. That representation is found at Parker Waichman LLP.
At Parker Waichman LLP, teams of experienced attorneys are prepared to pursue your case to its fullest extent to earn you the compensation that you deserve. Don’t wait. Let Parker Waichman earn you the compensation that you deserve. Contact Parker Waichman today for a free consultation and begin your path to justice.