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Product Safety Alerts 2003

       29 Dec 2003: Control of aristolochia
    In view of recent developments in China and Taiwan where the control of aristolochia has been tightened due to emerging cases of adverse reports associated with traditional Chinese medicine usage, aristolochic acids and their salts (the toxic constituents of aristolochia herbs) will be controlled under the Poisons Act with effect from 1 Jan 2004. With this new measure, products and herbs sold and supplied in Singapore are not allowed to contain aristolochic acids and their salts with effect from 1 Jan 2004.
       19 Dec 2003: Case reports of leukaemia and myelodysplastic syndrome in healthy donors treated with granulocyte colony-stimulating factor (G-CSF)
    HSA was notified of 2 cases of healthy donors in Japan who developed haematological disorders at the 1-year follow up after receiving of G-CSF for peripheral blood stem cells transplantation (PBSCT).
       17 Nov 2003: Case reports of extreme heat, smoke/fire occurring with sevoflurane (Sevorane®) administration in conjunction with dessicated carbon dioxide absorbents
    Abbott has reported rare, isolated cases of extreme heat, smoke, and/or fire that occurred in anesthesia machines during procedures where sevoflurane was used with a desiccated carbon dioxide. There are a total of 18 of such reports worldwide received since 1996.
       15 Nov 2003: Risk of hyperglycaemia and diabetes with atypical antipyschotics
    There have been increasing reports on the increased risks of hyperglycaemia and diabetes in patients treated with atypical antipsychotics. Patients treated with these drugs should be monitored for symptoms of hyperglycaemia including polydipsia, polyuria, polyphagia and weakness.
       15 Nov 2003: Safety concern of venlafaxine in children with depression
    Recent results from two clinical trials in children and adolescents (6 - 17 years) have failed to demonstrate its efficacy in depressive illness and the results showed an increase in harmful outcomes including hostility, suicidal ideation and self-harm in the venlafaxine group compared to the placebo group. It is advised that paediatric patients who are currently on venlafaxine should not have their medication discontinued abruptly because of the risk of withdrawal reactions.
       15 Nov 2003: Fruit juices and drug interactions
    Significant drugs interactions have been reported with grapefruit juice. These drugs include ciclosporin, terfenadine, ergot derivatives, calcium channel blockers and statins. There have also been reports suggesting an interaction between warfarin and cranberry juice, leading to changes in international normalised ratio (INR) values. Patients on warfarin should limit or avoid drinking cranberry juice.
       15 Nov 2003: Casodex® and early prostate cancer
    Trial results reveal increased risk of deaths when Casodex® is used in patients with localised (early) prostate cancer who would otherwise undergoing watchful waiting.
       15 Nov 2003: The SMART safety study and asthma management
    The interim analysis of a planned 28-week safety study, the Salmeterol Multi-center Asthma Research Trial (SMART) revealed rare but potentially serious, respiratory adverse events suspected to be associated with salmeterol.
       01 Oct 2003: Update on HRT: The Million Women Study
    The Million Women Study is a cohort study investigating the effects of specific types of HRT on breast cancer incidence and mortality.
       14 Jul 2003: Safety concerns on the use of paroxetine in children with major depression
    Paroxetine should not be used in children and adolescents under 18 years of age for the treatment of depression.
       14 Jul 2003: Contraindication of concomitant use of repaglinide with gemfibrozil
    Avoid concomitant use of repaglinide and gemfibrozil due to a higher risk of hypoglycaemia.
       04 Jun 2003: Recall of Pan Pharmaceuticals products
    To-date, 244 products manufactured by Pan Pharmaceuticals were recalled in Singapore. This follows the regulatory action taken by Therapeutics Goods Administration (TGA), Australia to suspend the manufacturing licence of Pan Pharmaceuticals following a series of safety and quality breaches on 28 April 2003.
       02 Apr 2003: Reported cases of oligohidrosis / hyperthermia in topiramate-treated patients
    Patients, especially paediatric patients, when treated with topiramate should be monitored for evidence of decreased sweating and increased body temperature, especially in warm or hot weather.
       15 Feb 2003: Nefazodone and liver failure
    Nefazodone is not recommended for use in patients with acute liver disease or elevated baseline serum transaminases.
       15 Feb 2003: Oral isotretinoin and psychiatric events
    Causal linkage between isotretinoin treatment and psychiatric events cannot be established from the observations in post-marketing reports due to under-reporting, the high incidence of psychiatric illness in the population and the incomplete nature of spontaneous reports. Nonetheless these post-marketing observations serve as important signals of a potential drug safety problem.
       15 Jan 2003: Precaution on the use of loratadine and desloratadine in pregnancy
    In 1999, the Swedish Medical Products Agency (MPA) reported an increased in frequency of hypospadias in boys born to 2,780 Swedish women who took loratadine (Clarityn®, Schering Plough) during their pregnancy. Fifteen cases were observed among these births. As a precautionary measure, it is advised that the use of loratadine or desloratadine (a metabolite of loratadine) during pregnancy be avoided.
Last updated on 02 Jul 2010 16:55:00
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