METHODOLOGY: From January 2001 to December 2005, we reviewed case reports of all bacteraemic melioidosis admitted to a tertiary teaching hospital, Hospital Universiti Sains Malaysia.
RESULTS: Thirty-five patients had positive blood culture for meliodosis and 27 case reports were traceable for further analysis. The mean age was 46.8 + 20.0 years. Twenty patients (74.1%) were male. The main clinical presentation was fever that occurred in 23 (85.2%) patients. Eighteen patients (66.7%) had lung involvement and three patients had liver abscess. Two patients presented with scrotal swelling, one of whom further developed Fournier's Gangrene. Nineteen (70.4%) patients had underlying diabetes, five of whom were newly diagnosed during the admission. Thirteen (48.1%) patients were treated with high-dose ceftazidime and six (22.2%) patients were treated with imipenem. Eight (29.6%) patients were not given anti-melioidosis therapy because the causative agents were not identified until after the patients died. The patients were admitted 16.8 days + 18.1. Seventeen patients (63.0%) died in this series, 13 patients of whom died within four days of admission.
CONCLUSIONS: The wide range of clinical presentations and the fatal outcomes of melioidosis require a high level of suspicion among physicians to develop an early appropriate therapy and reduce the mortality rate.
METHODS: Xenical 120 mg capsules (Roche, Basel, Switzerland) were used as reference material. Generic products were from India, Malaysia, Argentina, Philippines, Uruguay, and Taiwan. Colour, melting temperature, crystalline form, particle size, capsule fill mass, active pharmaceutical ingredient content, amount of impurities, and dissolution were compared. Standard physical and chemical laboratory tests were those developed by Roche for Xenical.
RESULTS: All nine generic products failed the Xenical specifications in four or more tests, and two generic products failed in seven tests. A failure common to all generic products was the amount of impurities present, mostly due to different by-products, including side-chain homologues not present in Xenical. Some impurities were unidentified. Two generic products tested failed the dissolution test, one product formed a capsule-shaped agglomerate on storage and resulted in poor (=15%) dissolution. Six generic products were powder formulations.
CONCLUSIONS: All tested generic orlistat products were pharmaceutically inferior to Xenical. The high levels of impurities in generic orlistat products are a major safety and tolerability concern.