Pinaverium bromide

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Pinaverium bromide Oesophageal ulcers following change to generic drug: case report A 40-year-old woman developed oesophageal ulcers after the pinaverium bromide preparation she was receiving for colitis was changed from Dicetel to Pinaverium Biogaran, a generic product. The woman had been receiving long-term treatment with Dicetel 100mg [frequency not stated] and had been strictly following the specifications for administration. Subsequently, Dicetel was replaced by its generic product Pinaverium Biogaran [dosage not stated] and, on treatment day 5, she developed severe pain in her upper retrosternal region. An endoscopy showed two ulcers, one of which was deeper than the other. Both ulcers were at the upper third region of her oesophagus and were drug-induced. The woman started receiving a proton pump inhibitor and Pinaverium Biogaran was discontinued. Her outcome was favourable and the ulcers did not reappear after restarting Dicetel. Author comment: The generic product may remain in the oesophagus for a longer time. It is possible that the lack of acrylic resin in the generic product is the cause of the prolonged duration of oesophageal transit and the observed lesions. Ahid S, et al. Pinaverium bromide-induced esophageal ulcerations. Therapie 63: 67-68, No. 1, Jan-Feb 2008 [French; summarised from a translation] 801114299 France

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Reactions 9 Aug 2008 No. 1214