FDA warns of significant risk of liver failure

2015-10-25 20:17:18 (GMT) (Caymanmama.com - News Providers Press Release News)

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Sacramento, CA, 10/23/2015 /SubmitPressRelease123/

The U.S. Food and Drug Administration (FDA) warns of significant risk of liver failure as a result of 26 such events related to Viekira Pack and Technivie which are anti-viral drugs used against Hepatitis C, produced by AbbVie Biopharmaceutical Company.  The FDA notes that liver injury from these drugs appear to be in patients with moderate to severe liver impairment and occurs within four weeks of starting the drug.


Viekira Pack and Technivie are fixed dosed antiviral drugs that are composed of multiple antivirals used in combination against two Genotype types of Hepatitis C, which is a form of viral hepatitis.  Viekira Pack is reported to have as many as 10,000 current patients.  Medical providers and the FDA are urging that patients not to stop these drugs without talking to their health providers for the fear of developing viral resistance.


Dr. Vigna clarifies that the package insert indicates that this drug is approved for use in those with Hepatitis C with minor chronic liver disease in the United States.  More likely than not there are just a few adverse events related to these drugs in the United States and these would be confined to patients managed by ‘maybe’ a few providers using these drugs ‘off label’ in those with moderate to severe chronic liver disease.  The drugs are not indicated for those with moderate-severe chronic liver disease that are classified as Child-Pugh Class B & C and only indicated for those with minor chronic liver disease also referred to Child-Pugh Class A.   Physicians have other ‘approved’ options for Hepatitis C patients with moderate-severe dysfunction or Child-Pugh Class B & C.


Greg Vigna, MD, JD, a Certified Life Care Planner, and National Pharmaceutical Attorney states, “As academic rehabilitation physician, working closely with the transplant team, caring for liver transplant patients in an acute rehabilitation hospital there are few surgical procedures that produce the level of debility than liver transplantation.  However, that being said this may be another example of off label use of a drug that causes harm”.


Dr. Vigna continues, “Hopefully, the adverse events are few related to this ‘off label use’ since the human cost is enormous for the patient and family.  Not only is there a huge amount of emotional stress on the patient and family it more often than not causes the family to become medically indigent because of the enormous cost of care.  Patients often need to relocate for several months to be close to their transplant teams for the necessary medical follow-ups and diagnostic test required. As a Certified Life Care Planner, I understand the cost of all the necessary and appropriate care going forward and it is enormous”.



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Dr. Greg Vigna, MD, JD

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