Listing 

26 Dec 2007: Suspension of Sales of Nimesulide in Singapore: HSA's Update
Following the suspension of the local sales of oral preparations containing nimesulide in June 2007, HSA has completed the review of available data on nimesulide. Due to the availability of other treatment options for the conditions that nimesulide is prescribed for, and including the fact that the risk of serious liver-related adverse reactions, although rare, cannot be effectively prevented in the local context, HSA has concluded that the risks of nimesulide outweigh its risks. Hence, the sales of oral nimesulide products will remain suspended and the relevant product licences will not be renewed upon expiry. The products in Singapore which will be affected are Nidol® Tablet, Nidol® Satchet, Nimotas-CD® Tablet, Nise® Tablet and Qnim MD® Tablet.

12 Dec 2007: Important safety warnings for gadolinium-based contrast agents (Omniscan® and Magnevist®)
The Pharmacovigilance Unit, together with its Pharmacovigilance Advisory Committee (PVAC), have reviewed available information regarding gadolinium-based contrast agents (GBCAs), licensed for use in magnetic resonance imaging (MRI), and their association with cases of nephrogenic fibrosing dermopathy (NFD) and nephrogenic systemic fibrosis (NSF) reported worldwide. Based on the available information, use of Omniscan® or Magnevist® is contraindicated in patients with severe renal failure. All other gadolinium-based contrast agents should only be used in patients with severe renal impairment only when absolutely necessary.

27 Nov 2007: Important safety warnings for Definity® (perflutren liquid microsphere) [Research Biolabs]
Post-marketing reports of rare but serious immediate and potentially life-threatening hypersensitivity reactions and central nervous system reactions including seizures and seizure-like reactions, as well as serious cardiopulmonary reactions have been reported with Definity® (perflutren liquid microsphere). The package insert for Definity® has been updated to warn physicians of such possible adverse reactions. In view of the cardiopulmonary reactions, patients should be monitored during and for 30 minutes following Definity® administration.

12 Nov 2007: Congenital malformations observed following use of mycophenolate mofetil (Cellcept®) in pregnancy [by Roche]
Roche would like to inform healthcare professionals of the increased risk of congenital malformation (ear malformations) in children of patients treated with Cellcept® during pregnancy. Roche has in its Dear Healthcare Professional Letter, reminded healthcare professionals of several special precautions to take regarding the use of Cellcept® in pregnancy.

30 Oct 2007: HSA's advisory on the use of cough and cold medicines in children
Concerns have been raised regarding the safety of over-the-counter (non-prescription) cough and cold medicines in children in view of the recent recall in the US of several such products and the ensuing recommendation from the public advisory committee meeting convened by the US FDA on the safe use of these medicines in young children. HSA is providing an interim advisory to healthcare professionals on the appropriate use of these products while we continue to review the scientific data.

07 Sep 2007: Association of salbutamol with myocardial ischaemia when used during premature labour in pregnant women [by GlaxoSmithKline]
Healthcare professionals are advised to exercise caution when administering salbutamol during premature labour, with careful monitoring of cardiovascular function including ECG and discontinuation of the drug if signs of myocardial ischaemia develop. Very rare adverse events of myocardial ischaemia, myocardial infarction, chest pain and ECG abnormalities have been reported after intravenous or oral salbutamol administration for the management of premature labour in women.

07 Sep 2007: Advisory of Avandia® (rosiglitazone) and Avandamet® (rosiglitazone/metformin) in patients with congestive heart failure [by GlaxoSmithKline]
Thiazolidinediones, including rosiglitazone can cause fluid retention which may lead to or exacerbate heart failure in patients with type 2 diabetes mellitus. GlaxoSmithKline is reminding healthcare professionals to monitor their patients for signs and symptoms of adverse reactions relating to fluid retention, including heart failure after initiation of rosiglitazone or rosiglitazone-containing products. Initiation of rosiglitazone or rosiglitazone-containing products is contraindicated in patients with NYHA Class III and IV heart failure.

07 Sep 2007: Kaletra® (lopinavir / ritonavir) and accidental overdose in children [by Abbott]
Abbott has issued a Dear Healthcare Professional Letter to inform of an accidental overdose that occurred with a paediatric patient taking Kaletra® (lopinavir / ritonavir) oral solution. The infant received a significantly larger dose of Kaletra and subsequently died. Healthcare professionals are reminded about the dosing guidelines of Kaletra® to minimize the risk for medication errors.

04 Sep 2007: Voluntary withdrawal of clobutinol (Silomat®) syrup [by Boehringer and HSA]
In consultation with the Health Sciences Authority (HSA), Boehringer Ingelheim is initiating a voluntary withdrawal of its product, Silomat® syrup (clobutinol) 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.

13 Aug 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.

13 Aug 2007: Deferasirox (Exjade®) with acute renal failure and blood cytopenias [by Novartis]
There were reports of acute renal failure (some with fatal outcome) following administration of deferasirox (Exjade®). There were also postmarket reports of cytopenia. Most had pre-existing haematological diseases that frequently involve bone marrow failure. Physicians are advised to monitor patient's serum creatinine levels, proteinuria and blood tests during deferasirox therapy.

13 Aug 2007: Reports of atrial fibrillation observed with zolendronic acid (Zometa®) from clinical study [by Novartis]
Novartis informed about possible treatment-related findings of atrial fibrillation observed in a recently completed phase III pivotal fracture trial with zoledronic acid (Zometa®) in women with postmenopausal osteoporosis. About 1.3% of patients (n=50) in the zoledronic acid group had serious atrial fibrillation as compared with 0.5% (n=20) in the placebo group (P<0.001). Healthcare professionals are encouraged to report all adverse events associated with the use of zolendronic acid.

11 Jun 2007: Suspension of sales of nimesulide following signals of liver toxicities
The suspension of sales has been prompted by Irish Medicines Board's recent suspension of all oral nimesulide-containing products. Our review of the safety profile of nimesulide concluded that the risk-benefit balance of nimesulide is unfavourable because of the risk of severe hepatic reactions, as well as the availability of alternative drugs to treat the conditions that nimesulide is indicated for. Doctors are advised not to prescribe nimesulide to new patients and to review alternative treatment options for patients currently taking nimesulide.

15 May 2007: Association of bevacizumab (Avastin®) with tracheo-esophageal fistula [by Roche]
This safety information concerns the occurrence of tracheo-esophageal fistula in a study where Avastin® (bevacizumab) is used with concurrent chemotherapy (irinotecan and carboplatin) and radiation in patients with limited-stage small cell lung cancer (SCLC). Avastin® is not indicated for use in SCLC, or for use in combination with concurrent radiotherapy with chemotherapy. It is recommended that physicians permanently discontinue the use of Avastin® in patients with tracheo-esophageal fistula or any grade 4 fistula. In cases of internal fistula not arising in the gastrointestinal tract, discontinuation of Avastin® should also be considered.
 
03 Apr 2007: Sales of tegaserod (Zelmac®) temporarily withheld
The withholding of sales has been prompted by the recent findings of a statistically significant increase in the incidence of cardiovascular events in patients taking Zelmac® (tegaserod). Analysis of 29 short-term randomised controlled clinical trials of Zelmac® involving more than 11,600 patients showed an imbalance of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelmac® compared to patients given placebo. Zelmac® is approved for irritable bowel syndrome (IBS) with constipation in females and chronic idiopathic constipation for patients less than 65 years old.

08 Mar 2007: Clinical trial observation of an increased incidence of fractures in female patients receiving long-term treatment with Avandia. (rosiglitazone) for type 2 diabetes mellitus [by GlaxoSmithKline]
GSK notified healthcare professionals of the results of a randomised, double-blind parallel group study [ADOPT] of 4,360 patients with recently diagnosed type 2 diabetes mellitus followed for 4-6 years to compare glycaemic control with rosiglitazone (Avandia®) relative to metformin and glyburide monotherapies. Significantly more female patients who received rosiglitazone experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide. An independent safety committee reviewed an interim analysis of fractures in another large; ongoing; controlled clinical trial and preliminary analysis was reported as being consistent with the observations from ADOPT. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with rosiglitazone.

05 Mar 2007: Risk of developing HIV resistance cannot be excluded with Baraclude® (entecavir) therapy in HIV/HBV co-infected patients not receving HAART [by Bristol-Myers Suibb]
BMS would like to advise that the risk of developing human immunodeficiency virus (HIV) resistance cannot be excluded when considering therapy with Baraclude® (entecavir) in an HIV/HBV co-infected patients not receiving highly active anti-retroviral therapy (HAART), based on current information. The use of Baraclude® in HIV/HBV co-infected patients not simultaneously receiving effective HIV treatment has not been evaluated. A case report in which a HIV variant containing the M184V resistance substitution was documented during Baraclude® treatment.

16 Feb 2007: Ranibizumab (Lucentis®) and risk of stroke [by Novartis]
In an ongoing study (SAILOR) of ranibizumab (Lucentis®) delivered intravitreally to patients with neovascular (wet) age-related macular degeneration, it showed a higher incidence of stroke in the 0.5mg dose group compared with the 0.3mg dose group. Patients with a history of prior stroke appeared to be at a higher risk for a subsequent stroke.