FDA approves stand-alone version of ribavirin for treatment of hepatitis C
Thursday, July 26th 2001, 12:00 am
By: News On 6
WASHINGTON (AP) _ Hepatitis C patients will soon be able to buy a popular treatment separately instead of packaged with another drug.
Schering-Plough Corp. markets the top-selling treatment, Rebetron, a kit containing both ribavirin and interferon-A.
Patients with the dangerous liver virus have long chafed at having to buy a two-drug kit. It is hard to customize the ribavirin dose, and Rebetron is expensive, costing $1,400 to $1,600 for a month's supply.
Thursday, the Food and Drug Administration gave Schering permission to sell ribavirin in a separate package under the name Rebetol.
The decision will make it easier for patients to adjust ribavirin doses, because to get more of that drug they won't have to buy an entire second Rebetron kit.
A Schering spokesman refused to release Rebetol's price until sales begin this fall, and stressed that it is formally approved only for use with Schering's interferon brand called Intron A.
But it is legal for doctors to prescribe drugs in ways other than those approved by the FDA, meaning some patients may begin using Rebetol _ the only version of ribavirin sold _ with other brands of interferon.
Rebetol can cause serious side effects, and thus patients will get a special warning brochure with each package, the FDA said. Among the warnings:
_Rebetol can cause anemia, so patients need regular blood tests.
_People with certain heart diseases should not take Rebetol, because patients with Rebetol-caused anemia have suffered heart attacks.
_It can cause birth defects and fetal death. Women must not become pregnant while taking Rebetol or for six months after they or their sexual partner stopped taking it.
_Other side effects include fatigue, nausea, rash and itching.