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
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