Side effect and safety data for fenbufen

Abstract

The overall safety pattern of fenbufen has been evaluated in a total of 2,667 patients: 1,667 of them in domestic clinical studies and 1,000 in foreign pivotal studies. Comparisons of several hundred patients—each receiving aspirin, indomethacin, and placebo—were made. Detailed analysis of all reported adverse effects demonstrated that fenbufen is a relatively safe nonsteroidal anti-inflammatory drug. The incidence and severity of adverse gastrointestinal experiences in patients treated with fenbufen were less than those in patients treated with either aspirin or indomethacin. Life-table analysis showed that during the first three months of therapy, the overall incidence and severity of gastrointestinal reactions due to fenbufen therapy were similar to those observed with placebo therapy. Cutaneous disorders were reported in more fenbufen- than placebotreated patients during the first month of therapy, thereafter, the incidence was the same. Clinical laboratory results were evaluated in the 1,667 patients who received fenbufen in domestic studies. Elevations of alkaline phosphatase and serum glutamic oxaloacetic transaminase levels, occurred occasionally with eosinophilla, particularly during the first four weeks of therapy with fenbufen. In the majority of cases, however, these abnormal values returned to normal or near-normal values with continuance of fenbufen therapy. No cases of drug-related jaundice have been reported either in clinical trials or from countries where fenbufen is marketed. No clinically significant changes were observed in other laboratory parameters including total bilirubin, blood urea nitrogen, white blood cell count, platelets, hematocrit, hemoglobin, and stool occult blood. In summary, fenbufen was well tolerated and provides a good therapeutic ratio, particularly in respect to gastrointestinal intolerance.