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12 Dec 2007: Updates on the use of cough and cold medicines in children | ||
| In view of concerns raised on the recent recall in the United States of over-the-counter cough and cold products marketed for infants and toddlers, and the ensuing recommendations from the public advisory committee meeting convened by the US Food & Drug Administration (FDA) on the safe use of these medicines in young children, HSA has provided an interim advisory to healthcare professionals on the appropriate use of these products while we continue to review the scientific data. |
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12 Dec 2007: Association of salbutamol and myocardial ischaemia in premature labour | ||
| GlaxoSmithKline (GSK) has issued a Dear Healthcare Professional Letter to alert our healthcare professionals on reports of myocardial ischaemia associated with the use of salbutamol (Ventolin®) as a tocolytic agent. GSK also advised healthcare professionals to exercise caution when using salbutamol for premature labour, to carefully monitor the patient’s cardiovascular function including ECG, and to discontinue the drug if signs of myocardial ischaemia develop. |
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12 Dec 2007: Gadolinium-based contrast agents – Important safety information | ||
| Arising from the emerging concerns associated with gadolinium-based contrast agents (GBCAs) and the potential increased risk of nephrogenic fibrosing dermopathy (NFD) and nephrogenic systemic fibrosis (NSF), the Health Sciences Authority (HSA) and its Pharmacovigilance Advisory Committee have reviewed the safety profile and use of these products, particularly in patients with renal dysfunction. |
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12 Dec 2007: Risk of torsade de pointes and QT prolongation with haloperidol | ||
| The US Food and Drug Administration (FDA) has recently issued a safety alert which highlights the potential increased risk of QT prolongation and torsade de pointes (TdP) with the use of intravenous (IV) administration of haloperidol. |
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12 Dec 2007: Reports of adverse reactions to Beauty Express® Miracle Pigmentation Scar Cream | ||
| The cosmetic product, Beauty Express® Miracle Pigmentation Scar Cream was tested by HSA to contain betamethasone dipropionate 0.023%, a potent steroid following reports of adverse drug reactions to the product. |
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07 Nov 2007: Sales of aprotinin (Trasylol®) temporarily suspended | ||
| The sales of aprotinin (Trasylol®) has temporarily been suspended by Bayer due to the interim analysis of the Canadian BART study which suggest as a higher risk of mortality (when compared with active comparators). While awaiting the final review of trial data by Bayer, HSA has worked with Bayer on an interim arrangement to allow restricted access for circumstances where there are no therapeutic alternatives and where the benefits outweigh the risks for the patient. |
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04 Sep 2007: Voluntary withdrawal of clobutinol (Silomat®) syrup | ||
| In consultation with the Health Sciences Authority (HSA), Boehringer Ingelheim is initiating a voluntary withdrawal of its product, clobutinol (Silomat®) syrup in Singapore with immediate effect. Preliminary results from a recent clinical study conducted by Boehringer Ingelheim suggest that clobutinol may have the potential to cause abnormal heart rhythm in certain individuals. However, the potential risk has been assessed to be small and is present only at the time of consumption. |
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16 Aug 2007: Reports of abnormal sleep-related events with zolpidem | ||
| There have been recent reports of abnormal and bizarre sleep-related behaviours in patients who are taking zolpidem (Stilnox®). |
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16 Aug 2007: Risk of heart valve damage with pergolide and cabergoline | ||
| Two recent case-control studies reported that pergolide (Celance®) and cabergoline (Dostinex®), which are ergot-derived dopamine agonists, commonly used in Parkinson's disease may be associated with an increased risk of heart valvulopathy. |
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16 Aug 2007: Cardiovascular risks with the use of ADHD drugs | ||
| HSA advises healthcare professionals to exercise caution when using ADHD drugs in patients (including children) with structural cardiac abnormalities or other serious heart problems. The ADHD drugs that are available locally include methylphenidate (Concerta®, Ritalin® and Rubifen®) and atomoxetine (Strattera®). |
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16 Aug 2007: Reports of adverse reactions to traditional medicines | ||
| HSA cautions against taking the three products which have been found to be adulterated with potent western medicinal ingredients: Santi Bovine Penis Erecting Capsule, Urat Madu and Asam Urat Flu Tulang - PJ. Dewandaru. |
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26 Jul 2007: Rosiglitazone - Update on cardiovascular safety profile | ||
| The risk of cardiac adverse events (i.e. heart failure, fluid retention, oedema) is known to be associated with the thiazolidinediones class of drugs. Recently, concerns have been raised about the possible elevation of ischaemic cardiovascular (CV) risk with rosiglitazone therapy. Prescribers are advised to continue to carefully make individualised treatment decisions for patients with diabetes mellitus. Patients on Avandia® should be monitored for signs and symptoms of heart failure, fluid retention, oedema and rapid increases in weight. |
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26 Jul 2007: Updates on non-selective non-steroidal anti-inflammatory drugs and cardiovascular risk | ||
| Non-selective NSAIDs may be associated with a small increase in the absolute risk of cardiovascular events (e.g. myocardial infarction and stroke), especially when used at high doses for long-term treatment. NSAIDs should be prescribed at the lowest effective dose and the duration of treatment should be periodically reviewed and kept as short as possible. NSAIDs should not be used perioperatively in patients who have recently undergone coronary artery bypass graft (CABG) surgery and revascularisation procedures. |
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05 Jul 2007: Restrictions on the supply of tegaserod (Zelmac®) and special access for patients who have no therapeutic alternatives | ||
| The sales of tegaserod (Zelmac®) has been suspended with effect from 3 Apr 2007 due to safety concern of a small increase in the number of cardiovascular ischaemic events in patients treated with tegaserod when compared to placebo. HSA has worked with Novartis to allow a small group of patients who have been assessed by their physicians to have no other therapeutic options, to have special access to tegaserod. |
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15 Jun 2007: Nimesulide: Suspension of sales following signals of liver toxicities | ||
| HSA is suspending the sales of oral preparations containing a non-steroidal anti-inflammatory drug (NSAID), nimesulide, in Singapore. This suspension is being taken as a precautionary measure in view of new information suggesting an increased risk of liver toxicity compared to other drugs in the same class of NSAIDs. |
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3 Apr 2007: HSA requests Novartis to temporarily withhold sales of tegaserod (Zelmac®) | ||
| A recent pooled analysis of clinical trials identified an increase in cardiovascular events in patients treated with Zelmac® as compared to placebo. Novartis has temporarily withheld sales of Zelmac® pending further evaluation of safety information. Patients currently taking Zelmac® are advised to stop taking the drug and consult their doctor. |
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29 Mar 2007: Reports of fractures with alendronate (Fosamax®) | ||
| There have been reports of fractures with long-term use of alendronate although the causal link could not be established. The types of fractures experienced by these patients were mainly sub-trochanteric in nature. It is recommended to monitor patient's bone mineral density before and during drug therapy. |
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29 Mar 2007: Linezolid: safety findings from a clinical trial in catheter-related infections | ||
| Linezolid (Zyvox®) has no clinical activity against gram-negative pathogens and is not approved for the treatment of gram-negative infections or for the treatment of patients with catheter-related bloodstream infections. Specific gram-negative therapy is required if a concomitant gram-negative pathogen is documented or suspected. |
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29 Mar 2007: New safety issues associated with rituximab (Mabthera®) | ||
| There have been reports of hepatic failure, bowel obstruction and perforation, and progressive multifocal leukoencephalopathy suspected with the use of rituximab. |
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29 Mar 2007: Evra® and risk of thromboembolism | ||
| There have been concerns as to whether Evra® (a transdermal contraceptive patch containing 6mg norelgestromin and 0.6mg ethinylestradiol) could be associated with a higher venous thromboembolism (VTE) risk compared to those who are on combined oral contraceptives. |
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29 Mar 2007: Bevacizumab (Avastin®)– association with hypertensive encephalopathy and reversible posterior leukoencephalopathy syndrome |
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08 Mar 2007: Warning against taking "Urat Madu" | ||
| The Health Sciences Authority (HSA) warns members of the public not to consume an illegal medicinal product labeled as “Urat Madu” which has been found to contain sildenafil. |



