A POST‐MARKETING SURVEILLANCE STUDY OF ®VOLTAROL 75 mg SR IN THE PRIMARY CARE SETTING

Abstract

SUMMARY 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.