A post-marketing surveillance study of Voltarol 75 mg SR in the primary care setting.

Abstract

A total of 7438 patients suffering from a wide variety of painful conditions was included in the final analysis of a post-marketing surveillance (PMS) study monitoring the use of Voltarol 75 mg SR in a primary care setting. Follow-up data were collected at visits conducted one, four and 12 months after the initial consultation. Improvement of symptoms was the most common reason for discontinuation of treatment (47% of patients who discontinued). Adverse events led to the withdrawal of 18% of patients overall. The rate of serious gastrointestinal complications was low (0.4%) and deleterious hepatic or renal effects were not apparent. There were significantly more events experienced by female patients and there was a significant effect of age on severe gastrointestinal events. In this PMS study Voltarol 75 mg SR was used successfully once or twice daily without any unexpected adverse effects in a manner consistent with current recommendations for the use of non-steroidal anti-inflammatory drugs.