Cimetidine Postmarket Outpatient Surveillance Program

Abstract

A postmarket surveillance program in outpatients receiving cimetidine was initiated seven months after its approval for marketing. During the first phase of the program, data were obtained over a three-month period for 9,907 patients who received the drug. The overall incidence of adverse effects reported was 4.4%, and the types of adverse effects did not differ from those reported in premarketing controlled studies. Physician response was excellent (85.1%), and the methods used were successful in providing data on a large number of patients who received the drug in routine clinical practice. The results confirmed the safety profile of cimetidine. A follow-up phase, initiated six months after the initial phase of the surveillance program, will provide longer-term data on these patients.

Pirenzepine versus Cimetidine in Duodenal Ulcer

“…These are well-known, un wanted effects of this treatment [18], On the other hand, it is rather difficult to understand a further side effect, namely blurred vision, which has been observed in 2 cimetidinetreated patients. This unwanted effect has not been observed in previous clinical trials or in post-marketing surveillance studies [ 19], One possible explanation may be that in order to obtain their consent, the patients w'ere also made aware of possible antimuscarinic side effects. However, none of the patients in the placebo group complained of any similar side effects.…”

Procainamide—Cimetidine Interaction: A Potential Toxic Interaction in the Elderly

“…Cimetidine has proven efficacy in the treatment of peptic ulcer disease and is widely prescribed for such conditions as gastric ulcers, duodenal ulcers, stress ulcers, and erosive gastritis 1,2 . Despite its relatively low incidence of side effects, a large number of drug interactions with cimetidine have been reported in the medical literature 1–3 . Drugs reported to interact with cimetidine include phenytoin, carbamazepine, theophylline, beta‐blockers, warfarin, benzodiazepines, quinidine, and procainamide 1,4,5 .…”

“…atively low incidence of side effects, a large number of drug interactions with cimetidine have been reported in the medical literature. [1][2][3] Drugs reported to interact with cimetidine include phenytoin, carbamazepine, theophylline, beta-blockers, warfarin, benzodiazepines, quinidine, and procainamide. l s 4 s 5 The suspected mechanism for the majority of these interactions is a competitive inhibition of the liver microsomal enzymes cytochrome P-450 and P-448.…”