Product Liability

FDA panel considers risks, benefits of experimental hepatitis C drug

A Food and Drug Administration (FDA) advisory committee this week will vote whether recommend the approval for Merck & Co.’s new hepatitis C drug boceprevir. Clinical trials with the drug have shown promising results, but potential side effects have left the committee questioning the drug’s safety.

The biggest concern the FDA’s Antiviral Drugs Advisory Committee has about boceprevir is the increased risk and severity of anemia and other blood disorders in patients who use the drug. Anemia is a decrease in the number of blood cells. Red blood cells carry oxygen from the lungs to the tissues. Depending on the severity of anemia, there can be a wide range of clinical consequences.

Hepatitis C is a liver disease caused by the hepatitis C virus. It is spread when the blood of an infected person enters another person’s, such as through shared needles or other non-sterile instruments such as body piercings or tattoos. About 3.2 million Americans are infected with hepatitis C.

Two studies with boceprevir, when used with other drugs, showed that the drug was far more effective at treating hepatitis C. However, certain groups of individuals, such as African-Americans and patients with more advanced disease, did not respond well to boceprevir. A very small number of patients – less than 1 percent – also reported symptoms of suicidal and homicidal ideation.

The panel will vote on whether to recommend that the FDA approve boceprevir. The FDA is not required to follow the recommendations of its advisory panels, but it usually does. A panel vote is expected later this week.