Widespread hyoscine hydrobromide toxicity due to contract manufacturer malpractice : the travacalm episode.
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.
McEwen
John
J
Therapeutic Goods Administration, Symonston, Woden, Australian Capital Territory, Australia. mcewenj@webone.com.au
Thompson
Barry R
BR
Purcell
Patrick M
PM
Kelly
Larry F
LF
Krauss
Adrian S
AS
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
D013607:Tablets; D012601:Scopolamine