Abstract

In the first year after registration, 103 reports on suspected adverse reaction to piroxicam (Feldene) were submitted to the Norwegian Adverse Drug Reaction Committee. Eighty-three reactions were classified as probable side-effects, and 73 of these were related to the upper gastrointestinal tract. Peptic ulcer and upper gastrointestinal haemorrhages predominated. Two deaths were classified as probably due to piroxicam. There were 8 life-threatening reactions, all due to haemorrhages. No severe cutaneous reactions were reported. A significant fraction of the gastrointestinal reactions occurred in patients with a previous history of peptic ulcer disease. Nearly every fourth patient with proven ulcer or haematemesis/melaena had simultaneously been taking other drugs with the propensity of causing gastrointestinal haemorrhage. The gastrointestinal adverse reactions to piroxicam can probably be reduced by a more accurate selection of patients.