New Warnings Placed On Rebetron Hepatitis Therapy
PHILADELPHIA, PA — Feb. 18, 1999 — After just six months on the market, revised safety information tells doctors and patients to be even more cautious in the use of combination therapy to treat hepatitis C.
A black box warning in the revised prescribing information for Schering-Plough’s Rebetron(TM) warns that patients and their partners must use two forms of contraception because of the risk of birth defects or loss of a pregnancy from combination therapy.
Even if only one partner is taking Rebetron, both members of the couple need to use adequate contraception during therapy and for six months after the end of treatment.
Rebetron is a combination of Rebetol(R) (ribavirin, USP) Capsules and Intron(R) A (interferon alfa-2b, recombinant) Injection. It is the ribavirin component that is blamed for the risks to the fetus.
The United States Food and Drug Administration recently approved Rebetron combination therapy for patients with hepatitis C who had never been treated before. Previously, only people who had failed a previous treatment could receive Rebetron. But at the same time as it allowed wider use, the FDA increased the warnings to reflect the danger of the combination therapy during pregnancy. Ever since Rebetron was first approved, Schering-Plough has maintained a registry to track people on the therapy who become pregnant.
Dr. Enrique Molina, a hepatologist and assistant professor of clinical medicine at the Center for Liver Diseases, University of Miami, FL., says no patients with pregnancy-related complications from Rebetron treatment have been referred to his practice yet. However, he feels physicians need to counsel patients carefully before prescribing Rebetron.
“If a patient is not willing to practice strict contraception, that’s certainly a contraindication for ribavirin. It makes a bigger difference for younger patients than for older ones,” he said. “Many of our patients are 40 or 50 and already practising contraception so it’s not a big issue for them, but for those that are younger, it’s definitely an important point for physicians to stress.”