Product Safety Alerts 2005

       12 Dec 2005: Safety update on the use of promethazine in children
    The Health Sciences Authority (HSA) and its Pharmacovigilance Advisory Committee (PVAC) have recently reviewed the safety profile of promethazine in children.
       12 Dec 2005: Topical immunomodulators for treatment of atopic dermatitis
    There are recent concerns over the increasing use of topical immunomodulators (e.g. pimecrolimus cream (Elidel®) and tacrolimus ointment (Protopic®)) especially in very young children and the findings of carcinogenicity in some of the animal studies as well as post-marketing reports of malignancies.
       12 Dec 2005: Drug interaction between capecitabine (Xeloda®) & warfarin
    Co-administration of capecitabine and warfarin may predispose patients to an increased risk of bleeding. The probable mechanism for the interaction is the down-regulation of CYP2C9 isoenzyme by which warfarin is principally metabolised.
       12 Dec 2005: Paroxetine (Seroxat®) & possible risk of teratogenicity
    Use of paroxetine in first trimester of pregnancy may result in a possible risk of congenital malformations over other antidepressants.
       12 Dec 2005: Suicidality risk associated with atomoxetine (Strattera®)
    Eli Lilly and Company has issued a Dear Healthcare Professional Letter to alert healthcare professionals of an increased risk of suicidal thinking in children and adolescents associated with the use of Strattera®.
       17 Jun 2005: 2005 HSA cautions against self-medication with medicines obtained from dubious sources
    HSA has recently received reports of adverse reactions associated with the use of traditional medicines. Analytical testing confirmed that these products were adulterated with western drugs. The adulterated products are Jamu Kenis Pil, Jamu Pegal Linu, Kapsul Asam Urat (TCU), Ramuan Tradisional Madura and Snake Powder Capsule.
       03 Jun 2005: HSA's public advisory on overseas reports concerning products containing herbal extracts of Coleus forskohlii
    The Italian Medicines Agency (AIFA) received 4 cases of acute atropine-like poisoning relating to the consumption of products containing the herbal extracts of Coleus forskohlii. Preliminary assessment was that this could be the result of possible batch contamination.
       12 May 2005: Potential problem of falsely elevated blood glucose readings with Extraneal® peritoneal dialysis solution
    Patients on Extraneal® (icodextrin-containing peritoneal dialysis solution) will get falsely elevated blood glucose reading when they are using glucose monitoring systems that are based on glucose dehydrogenase-pyrroloquinolinequinone (GDH-PQQ) method.
       28 Apr 2005: HSA expert advisory committee's recommendations on COX-2 selective and non-selective NSAIDs
    The Health Sciences Authority has recently convened an expert advisory committee to deliberate on the risk-benefit balance of COX-2 selective and non-selective NSAIDs following recent emerging concerns on the safety of this class of drugs. The attached Dear Healthcare Professional Letter includes the findings of the committee and its recommendations.
       08 Apr 2005: Suspension of sales of valdecoxib (Bextra®)
    HSA has requested Pfizer (Singapore) to voluntarily suspense the sales of Bextra® in Singapore until safety issues have been resolved. Pfizer (Singapore) has agreed and will be discontinuing sales with immediate effect. Patients on Bextra® should contact their physicians to discuss discontinuing use and alternative treatment. Following the US FDA's recent announcement on the cyclo-oxygenase 2 (COX-2) inhibitors and non-selective non-steriodal anti-inflammatory drugs (NSAIDs) which includes the FDA's request to Pfizer to voluntarily withdraw Bextra® from the US market due to overall unfavourable risk versus benefit profile of the drug with respect to cardiovascular safety and serious skin reactions. Several other regulatory authorities including Health Canada and European Medicines Agency have requested Pfizer to voluntarily suspend the sales of Bextra® from these countries.
       31 Mar 2005: Deregistration of thioridazine
    All brands of thioridazine will be degistered with effect on 31 March 2006.
       31 Mar 2005: Safety concerns associated with use of erythropoietins (EPOs) in cancer patients
    Use of EPOs for preventiion of anaemia in cancer patients is no longer appropriate.
       31 Mar 2005: Safety update on tumour necrosis factor (TNF) inhibitors
    Reports of haematological events, malignancies and serious hepatotoxicity.
       17 Mar 2005: Effect of Depo-Provera® injection on bone mineral density
    New data suggest that women who use Depo-Provera® for long-term contraception may lose significant bone mineral density (BMD).
       24 Jan 2005: Termination of Reminyl® trials on mild cognitive impairment
    Data from 2 clinical trials on patients with mild cognitive impairment showed an increased mortality in the group receiving galantamine as compared to those receiving placebo.
Last updated on 02 Jul 2010 16:56:14