Healthy Skepticism Library item: 11106
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
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
