title: Widespread hyoscine hydrobromide toxicity due to contract manufacturer malpractice : the travacalm episode.
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.
authors.affiliation: Therapeutic Goods Administration, Symonston, Woden, Australian Capital Territory, Australia. mcewenj@webone.com.au
authors.forename: John
authors.initials: J
authors.lastname: McEwen
authors.forename: Barry R
authors.initials: BR
authors.lastname: Thompson
authors.forename: Patrick M
authors.initials: PM
authors.lastname: Purcell
authors.forename: Larry F
authors.initials: LF
authors.lastname: Kelly
authors.forename: Adrian S
authors.initials: AS
authors.lastname: Krauss
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D001315:Australia; D002648:Child; D032982:Contracts / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D004335:Drug and Narcotic Control; D005260:Female; D006801:Humans; D008297:Male; D008318:Malpractice / Q000331:legislation & jurisprudence*; D008875:Middle Aged; D009041:Motion Sickness / Q000517:prevention & control; D012601:Scopolamine / Q000008:administration & dosage / Q000506:poisoning*; D013607:Tablets
chemical_list: D013607:Tablets; D012601:Scopolamine