Q&A with AbbVie's Barry Bernstein, MD: Are More FDA Warnings in the Works ?

Note:  In addition to the label change and warning about their currently approved medications Dr. Bernstein gives an estimate on a possible approval of AbbVie's new pan-genotypic combination.  Alan


The effectiveness of the new arsenal of hepatitis C antivirals has elated physicians and patients and been a triumph—and lucrative development--for pharmaceutical companies.

The announcement on Oct. 22 that AbbVie, manufacturer of two such drug products was changing labeling to include new warnings dampened the euphoria. Post-marketing reports alerted the company and the US Food and Drug Administration (FDA) of patient deaths and severe liver damage sometimes requiring transplantation in some patients who received AbbVie’s treatments.

The company, in consultation with the FDA changed its package inserts and labeling for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and Technivie (ombitasvir, paritaprevir, and ritonavir tablets.

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