FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
| T01-31 | Print Media: 301-827-6242 |
| July 26, 2001 | Consumer Inquiries: 888-INFO-FDA |
The Food and Drug Administration today approved a stand-alone package of Rebetol Capsules (ribavirin), an anti-viral drug for use with Intron A (interferon alfa-2b) for the treatment of patients with chronic hepatitis C infection.
In 1998, FDA approved Rebetron Combination Therapy, a combination package containing Rebetol Capsules and Intron A for injection for treatment of patients with chronic hepatitis C infection who have not had previous interferon therapy or who have relapsed following successful interferon therapy. This approval was based on Schering's application to provide both Rebetol and Intron A in a single package. Schering Corporation markets both products. The new stand-alone package of Rebetol Capsules provides patients and health care providers with flexibility in adopting individualized ribavirin and interferon-based therapies.
The most important side effect of Rebetol Capsules is anemia. The anemia occurs within one to two weeks after therapy begins. Blood tests to check red blood cell counts should be obtained before treatment and two and four weeks after treatment begins, or more frequently if clinically indicated. Patients should have their red blood cell counts checked as often as their health care provider indicates.
Fatal and non-fatal heart attacks have occurred in patients with anemia caused by Rebetol Capsules. Therefore, patients with a history of significant or unstable heart disease should not be treated with Rebetol Capsules.
Rebetol Capsules may cause birth defects and may lead to death of the exposed fetus. To avoid these birth defects, extreme care must be taken to prevent pregnancy in female patients and female partners of male patients. Female patients must not be pregnant, or become pregnant while being treated with Rebetol Capsules and for six months after treatment has stopped. Female sexual partners of male patients being treated with Rebetol Capsules must not become pregnant during treatment and for six months after treatment has stopped. Therefore, at least two forms of birth control must be used during this time.
If pregnancy occurs in a patient or partner of a patient during treatment or during the six months after treatment stops, health care providers are encouraged to report such cases to the Rebetron Pregnancy Registry at (800) 727-7064.
Other common adverse events associated with Rebetol Capsules include fatigue, nausea, rash and itching.
Serious side effects due to Intron A include severe depression, psychoses, aggressive behavior, hallucinations, violent behavior (suicidal ideation, suicide attempts, suicides, and rare instances of homicidal ideation). These events have occurred in patients without a previous history of psychiatric illnesses. Intron A can cause a serious drop in the cells that help fight infections (white blood cells) and the cells that help bleeding stop (platelets).
A Medication Guide will accompany each prescription of Rebetol Capsules to explain the adverse events associated with Rebetol Capsules and Rebetron Combination Therapy as well as the appropriate use of the products.
Hepatitis C infection is a chronic condition caused by a virus that damages the liver. Rebetol Capsules are not effective for the treatment of chronic hepatitis C infection when used alone. They should be used only in combination with Intron A. The combination of Rebetol Capsules and Intron A works to suppress the level of hepatitis C virus in the blood, but this treatment does not cure the infection. Although the majority of patients infected with the hepatitis C virus do not develop liver disease, 10-20 percent will develop cirrhosis (advanced liver scarring), and approximately 1 to 5 percent will develop liver cancer after 20-30 years with the infection. The virus that causes hepatitis C infection is spread by contact with an infected person's blood.
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2001-JUL-26.