Healthy Skepticism Library item: 8399

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Maclay WP, Crowder D, Spiro S, Turner P.
Postmarketing surveillance: practical experience with ketotifen.
Br Med J (Clin Res Ed) 1984 Mar 24; 288:(6421):911-4
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=6423140

Abstract:

A report on the postmarketing surveillance of the efficacy and toxicity of ketotifen fumarate (Zaditen; I) in 8291 asthmatic patients in the United Kingdom who were followed up for one yr following initial prescribing was presented. Data were collected by the pharmaceutical firm and communicated to the appropriate regulatory authorities and participating physicians. By subjective assessment 70% of patients found the medication efficacious. There were no unexpected or unacceptable side effects and those found were similar to those reported in clinical trials of I. It was concluded that although this exercise showed that the pharmaceutical industry, regulatory authorities, and prescribing doctors were able to collaborate, the major outcome of the survey was already known and that it remains to be seen whether this type of survey is of value in the continuing search for control and safety in prescribing.

Keywords:
Adolescent Adult Aged Asthma/drug therapy* Child Communication Evaluation Studies* Female Humans Ketotifen/adverse effects* Ketotifen/therapeutic use Male Middle Aged Pregnancy Product Surveillance, Postmarketing* Prospective Studies