A leading consumer drug safety advocate warned last week that a popular class of drugs designed to treat hepatitis C may carry significant risks for liver damage and death, DrugNews has learned.
The report comes just months after the FDA itself issued a different warning on the new class of Hep C drugs, called direct-acting antivirals, that they may cause a return of Hepatitis B.
New Class of Hep C Drugs Too Good to be True?
Direct-acting antivirals have been praised for their ability to cure Hepatitis C, or at least suppress it to levels that are undetectable. For this, they also carry exorbitant price tags: usually between $55,000 and $125,000 per patient.
Although only released in 2013, over 250,000 patients now take these drugs each year. This has reaped huge profits on the select few drug companies that sell them.
Direct-acting antivirals are known by brand names such as Harvoni, Sovaldi, Olysio, Daklinza, Zepatier, Technivie and Viekira XR.
New Study Shows Widespread Liver Risks
In its new report, the Institute for Safe Medication Practices reviewed records of adverse event reports for direct-acting antivirals to the FDA from June 2015 through June of 2016. They discovered 1,058 reported cases of severe liver injury and 524 cases of liver failure. In over 760 cases, the medications failed to work.
Even worse, over 30% of the patients taking direct-acting antivirals who suffered liver failure eventually died.
While manufacturers have countered that such risks are inherent in those with hepatitis, the ISMP pointed out 9 in 10 cases of liver injury or death were reported by doctors as a drug side effect rather than being caused by hepatitis.
FDA Warns of Recurrent Liver Risks from DAAs
In October, the FDA first warned of liver risks from the new direct-acting antiviral class. In 24 reported cases, patients treating for hepatitis C actually suffered a reoccurrence of hepatitis B. This condition can also lead to liver failure, liver transplant or death.
Just this month, the FDA called for a new warning label to be added to these drugs based on the discovery of hepatitis B risks.
Since an estimated 75% of all drug side effects go unreported to the FDA, experts fear that the number of patients subjected to liver failure or death is much higher than indicated.
Also, it remains to be seen whether the makers of direct-acting antivirals knew of the severe risks for liver injury and death before marketing these drugs to the public. Lawyers suspect they could be liable to those patients affected for significant compensation.
For more information about direct-acting antivirals, or to speak directly with a lawyer about your case, contact DrugNews today.
Quarterwatch 2016 Q2. ISMP. (January 25, 2017). Retrieved from www.ismp.org
Sagonowsky, E. Breakthrough hep C meds carry risk for liver failure, death: report. FiercePharma. (January 25, 2017). Retrieved from www.fiercepharma.com
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