Label Changes for:

Rebetol (ribavirin) capsules and solution

November 2009

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009

WARNINGS AND PRECAUTIONS

Ophthalmologic Disorders
  • Ribavirin is used in combination therapy with alpha interferons. Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein, thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, papilledema, and serous retinal detachment...
Dental and Periodontal Disorders
  • Patients should brush their teeth thoroughly twice daily and have regular dental examinations If vomiting occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Impact on Growth - Pediatric Use
  • Data on the effects of PegIntron plus REBETOL on growth come from an open-label study in subjects 3 through 17 years of age, and weight and height changes are compared to U.S. normative population data. In general, the weight and height gain of...
  • Among the boys studied, the age groups of 3-11 years old and 12-17 years old had similar height percentile decreases...
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