Telaprevir, a oral drug used to treat hepatitis C, will now carry a Food
and Drug Administration (FDA) black box warning due to the risk of a potentially
Telaprevir, manufactured by Vertex Pharmaceuticals, is also marketed under
brand names Incivek and Incivo.
A black box warning is the strongest warning that the FDA requires and
is used when a drug has a significant risk of serious or life threatening effects.
Telaprevir has known adverse side effects including serious skin reactions.
During clinical trials prior to approval, some skin reactions were severe
enough to require hospitalization and were considered life threatening.
This risk was displayed on telapreir's original packaging. Less than
1% of patients were affected by serious side effects and those that were
eventually made a full recovery.
During post-marketing surveillance the Vertex Pharmaceuticals received
reports of death due to adverse skin reactions. The company has not reported
how many deaths have been contributed to side effects of the drug, but
they did make this statement, "Fatal cases of serious skin reactions
have been reported in patients with progressive rash and systemic symptoms
who continued to receive Incivek combination treatment after a serious
skin reaction was identified."
Vertex is stressing the importance of discontinuing the drug immediately
after a serious skin reaction is identified. They say the fatal cases
occurred with patients that continued to stay on the drug even after experiencing
a serious skin reaction.
As a consumer and a patient, you have the right to trust your medication
is safe. Tragically, this is not always the case. When a pharmaceutical
company acts negligently, its actions can result in serious side effects.
Victims, however, may recoup damages through successful product liability
claim against the drug's maker.
Our Telaprevir Attorneys represent victims across the country, we have
the experience necessary to stand toe-to-toe with big pharmaceutical companies,
our firm has the resources to successfully litigate a Telaprevir lawsuit,
if you have experienced Telaprevir side effects, our attorneys can help.
Call The Maher Law Firm today at 1-407-839-0866