The Adverse Drug Reaction New bulletin is published by the Pharmacovigilance Branch and Pharmacovigilance Advisory Committee (PVAC). The main aim of the bulletin is to increase the awareness of adverse drug reactions amongst healthcare professionals, and to promote adverse drug reaction reporting The bulletin is distributed to all the physicians, dentists and pharmacists.

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- Monitoring the safety profile of Influenza A/H1N1 (2009) vaccines
- Suspension of sales of dextropropoxyphene-containing products
- New online search on illegal health products
- Important drug interactions
- Compliance to the safety monitoring protocols of the 'RevAssure Programme' of Lenalidomide (Revlimid®)
- Tinzaparin (Innohep®) and risk of death in the elderly with renal impairment
- Summary of safety advisories issued by HSA and pharmaceutical companies
- Package insert amendments reflecting safety issues
- Local experience with oseltamivir (Tamiflu®)

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- Serious adverse skin reactions associated with allopurinol
- Voluntary recall of Hydroxycut® products in Singapore
- Electronic package inserts on HSA website
- Reporting vaccine-related adverse events
- Update on drotrecogin alfa (Xigris®) and increased risk of bleeding
- Traditional medicines adulterated with steroids
- Oral sodium phosphates (OSP) and renal toxicity
- Package insert amendments reflecting safety issues
- Reports of warfarin-glucosamine interaction

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- Serious adverse skin reactions associated with carbamazepine
- Cyproterone and meningiomas
- Codeine toxicity in breastfed infants
- Analysis of 2008 ADR reports
- Moxifloxacin (Avelox®): A safety update
- Package insert amendments reflecting safety issues
- Continuing Education Point accreditation of the HSA ADR News Bulletin
- Sales of efalizumab (Raptiva®) suspended

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- Sulphur allergy - A common misnomer in ADR reporting
- Continuing Professional Education (CPE) accreditation of the HSA ADR News Bulletin for pharmacists
- Abacavir hypersensitivity reactions associated with HLA-B*5701 allele
- Slimming health products (Relacore & Lami) adulterated with sibutramine
- Fentanyl transdermal patch and overseas reports of fatality
- Haemorrhagic or necrotizing pancreatitis assciated with Byetta®
- Summary of advisories issued by HSA and pharmaceutical companies
- Package insert amendments reflecting safety issues
- Biosimilar products

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- Adulterated illegal sexual enhancement products
- Tumor necrosis factor-alpha antagonists and serious skin reactions
- Update on aprotinin (Trasylol®)
- Withdrawal of indication of primary nocturnal enuresis for desmopressin nasal preparations
- Clozapine-induced gastrointestinal hypomotility
- PDE5 inhibitors associated with sensorineural hearing loss
- Updates on mycophenolate group of drugs
- Package insert amendments reflecting safety issues
- Varenicline (Champix®) and neuropsychiatric adverse events

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- HSA's communication of drug safety information to healthcare professionals (this is the cover article)
- Update on rosiglitazone and cardiovascular risks
- Strontium (Protos®): A safety update
- Analysis of ADR reports 2007
- Suicidality associated with antiepileptic drugs
- Update on suspension of sales of nimesulide in Singapore
- Package insert amendments reflecting safety issues
- Update on Evra® and thromboembolism

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- Updates on the use of cough and cold medicines in children
- Association of salbutamol & myocardial ischaemia in premature labour
- Gadolinium-based contrast agents – Important safety information
- Risk of torsade de pointes and QT prolongation with haloperidol
- Reports of adverse reactions to Beauty Express® Miracle Pigmentation Scar Cream
- Summary of advisories issued by HSA and companies
- Package insert amendments reflecting safety issues
- Voluntary withdrawal of clobutinol (Silomat®) cough syrup
- Voluntary suspension of sales of aprotinin (Trasylol®)

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- Update on non-selective NSAIDs and cardiovascular risk
- Nimesulide: Suspension of sales following signals of liver toxicities
- Reports of abnormal sleep-related events with zolpidem (Stilnox®)
- Risk of heart valve damage with pergolide (Celance®) and cabergoline (Dostinex®)
- Rosiglitazone (Avandia®): Update on cardiovascular safety profile
- Cardiovascular risks with the use of ADHD drugs i.e. methylphenidate (Concerta®, Ritalin® and Rubifen®) and atomoxetine (Strattera®).
- Reports of adverse reactions to traditional medicines: Santi Bovine Penis Erecting Capsule, Urat Madu and Asam Urat Flu Tulang
- Package insert amendments reflecting safety issues

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- Reports of fractures with alendronate (Fosamax®)
- Linezolid (Zyvox®): safety findings from a clinical trial in catheter-related infections
- New safety issues associated with rituximab (Mabthera®)
- Evra® & risk of thromboembolism
- Bevacizumab (Avastin®): association with hypertensive encephalopathy & reversible posterior leukoencephalopathy syndrome
- Analysis of ADR reports for 2006
- Package insert amendments reflecting safety issues (Oct 2006 - Jan 2007)

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- Oseltamivir (Tamiflu®) & neuropsychiatric events
- Eptifibatide (Integrilin®) & increased risk of bleeding in impaired renal function
- Life-threatening cases of serotonin syndrome with SSRI/SNRI-triptan combination
- Package insert amendments reflecting safety issues (Apr-Sep 2006)
- Raloxifene (Evista®) & risk of venous thomboembolism / fatal stroke
- Presence of heavy metals in traditional Indian medicines - Endopile®

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- ACE Inhibitors exposure in 1st trimester & congenital malformations
- Safety update on anti-TNF alpha products (i.e. Enbrel®, Humira® & Remicade®)
- Tibolone (Livial®) & LIFT study
- Reports of nephrogenic fibrosing dermopathy & nephrogenic systemic fibrosis following the use of gadolinium-containing agents
- Package insert amendments reflecting safey issues (Jan-Mar 2006)
- Potential risk of cutaneous vasculitis toxicities associated with hydroxyurea (Hydrea®)
- Case report of adverse reactions with Baike Wan capsules
- Black cohosh (Cimicifuga Racemosa) & hepatotoxicity

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- Safety update on gatifloxacin (Tequin®)
- Letrozole (Femara®) & adverse outcome in babies following maternal exposure
- Bosentan (Tracleer)® & serious liver injury
- Package insert amendments reflecting safey issues (Sep-Dec 2005)
- Analysis of ADR reports for year 2005
- Summary of advisories issued by HSA and companies
- Rosiglitazone & macular oedema

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- Safety update on the use of promethazine in children
- Topical immunomodulators (pimecrolimus, Elidel®, & tacrolimus, Protopic®) for treatment of atopic dermatitis
- Drug interaction between capecitabine (Xeloda®)& warfarin
- Package insert amendments reflecting safey issues (Jun-Aug 2005)
- Paroxetine & possible risk of teratogenicity
- Suicidality risk associated with atomoxetine (Strattera®)

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- Falsely elevated blood glucose readings with Extraneal® peritoneal dialysis solution
- Serious adverse reactions arising from adulterated complementary medicinal products
- Package insert amendments reflecting safey issues (Mar-May 2005)
- Vision disorders and erectile dysfunction drugs (i.e. Viagra®, Levitra®, Cialis®)
- HSA's recommendations on cyclooxygenase-2 (COX-2) selective and non-selective nonsteroidal anti-inflammatory drugs (NSAIDs)

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- Letter from editor: Update on coxib issue
- Safety concerns associated with use of erythropoietins (EPOs) in cancer patients
- Safety update on tumour necrosis factor (TNF) inhibitors (i.e. Enbrel®, Humira® & Remicade®)
- Package insert amendments reflecting safey issues (Nov 2004-Feb 2005)
- Analysis of ADR reports for year 2004
- Deregistration of thioridazine

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- Cyclooxygenase-2 specific inhibitors
- Lamictal® and interaction with oral contraceptives
- Bisphosphonates and osteonecrosis of the jaw
- Pergolide associated with cardiac valvulopathy
- Safety alert regarding medication errors - Reminyl® and Amaryl®
- Package insert amendments reflecting safey issues (May-Oct 2004)
- Antidepressants and increased risk of suicidality in children and adolescents

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- Use of SSRIs and related antidepressants in children and adolescents
- Serious drug-induced skin reactions
- Discontinuation of nefazodone (Serzone®)
- Conclusion of the Women's Health Initiative (WHI) trials
- Ischaemic colitis and other abdominal ADRs associated with tegaserod
- Atypical antipyschotics - risk of cerebrovasular adverse events in elderly patients with dementia
- Package insert amendments reflecting safey issues (Dec 2003-Apr 2004)
- Case reports of diabetic ketoacidosis with Kenis Pil® (Jamu medicine)
- Safety update on rosuvastatin (Crestor®) and new information on PK data

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- New preclinical findings on oseltamivir
- Case report of Cushing's syndrome with traditional medicine (Pil Ajaib®)
- Analysis of ADR reports for year 2003
- Doxycycline and oesophagitis
- Package insert amendments reflecting safey issues (Aug-Nov 2003)

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- Women's Health Initiative Memory Study (WHIMS)
- Safety concerns on the use of paroxetine in children with major depression
- Recall of Pan Pharmaceuticals products
- Contraindications of concomitant use of repaglinide with gemfibrozil
- Oxaliplatin (Eloxatin®) and infusion related ADRs
- Tamoxifen and uterine sarcoma

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- Increased risk of hyperglycaemia and diabetes with atypical antipyschotics
- Safety concern of venlafaxine (Efexor®/ Efexor XR®) in children
- Hypospadias and loratadine / desloratadine
- The SMART safety study and asthma management
- Update on HRT: The Million Women Study
- Oligohidrosis and hyperthermia with Topamax® (Topiramate)
- Fruit juices and drug interactions
- Casodex® (bicalutamide) and early prostate cancer

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- Nefazodone and liver failure
- Update on Eprex® (epoetin alfa) and pure red cell aplasia
- Analysis of ADR reports for year 2002
- Careful use of oral isotretinoin

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- Oral combined hormone replacement therapy
- Editorial note: Slim 10®
- Third generation oral contraceptives and venous thromboembolism
- Updated report on sibutramine (Reductil®)
- Kava-kava and liver toxicities
- Eprex® (epoetin alfa) and reports of pure red cell aplasia

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- Phenylbutazone in Jamu Medicine, Serbuk Jarem (Encok)®
- Cardiodepressant effect of itraconazole (Sporanox®)
- Analysis of ADR reports for year 2001
- Clozapine and myocarditis

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If you have problem viewing the document, the please send email to HSA_drugsafety@hsa.gov.sg.

Healthcare professionals can request for a copy of the Adverse Drug Reaction News bulletin by contacting the branch at:

Pharmacovigilance Branch
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way
#11-03 Helios
Singapore 138667
Tel: (65) 6866 3538 Fax: (65) 6478 9069
Email: HSA_drugsafety@hsa.gov.sg