Healthy Skepticism Library item: 11106

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Publication type: Journal Article

McEwen J, Thompson BR, Purcell PM, Kelly LF, Krauss AS.
Widespread hyoscine hydrobromide toxicity due to contract manufacturer malpractice : the travacalm episode.
Drug Saf 2007; 30:(5):375-8
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=PubMed&Cmd=ShowDetailView&TermToSearch=17472417&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

Abstract:

An outbreak of hyoscine hydrobromide toxicity was detected through the Australian pharmacovigilance system. The unexpectedly wide variation in hyoscine hydrobromide content between individual tablets within single packets created difficulties in initially explaining the clinical experiences. Strict time requirements for review of incoming adverse drug reaction reports and close involvement of the highly skilled national drug regulatory laboratory resulted in early identification of the cause of the outbreak and led in turn to the identification of malpractice by the contract manufacturer.

Keywords:
MeSH Terms: Adult Adverse Drug Reaction Reporting Systems Australia Child Contracts/legislation & jurisprudence* Drug Industry/legislation & jurisprudence* Drug and Narcotic Control Female Humans Male Malpractice/legislation & jurisprudence* Middle Aged Motion Sickness/prevention & control Scopolamine/administration & dosage Scopolamine/poisoning* Tablets Substances: Tablets Scopolamine