Details of the Dear Healthcare Professional Letters can be found on the Health Professionals Portal (HPP). HPP was developed for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists are required to log in at http://www.hpp.moh.gov.sg/.
 |
Listing
4 Nov 2009: Influenza A (H1N1) Vaccines-monitoring safety profile
With the initiation of H1N1 vaccination, the Pharmacovigilance Branch, HSA is providing additional information on the procedures to monitor the safety profile of the H1N1 influenza vaccines. MOH and HSA will be intensifying our efforts to closely monitor the safety and usage of H1N1 vaccines in our local population. Therefore, healthcare professionals are required to
· notify the National Immunization Registry (NIR) of all patients who have been vaccinated with H1N1 vaccines
· report all suspected serious vaccine adverse events (VAE) to HSA.
· notify the National Immunization Registry (NIR) of all patients who have been vaccinated with H1N1 vaccines
· report all suspected serious vaccine adverse events (VAE) to HSA.
The information provided by healthcare professionals will allow HSA to accurately compute the incidence rate of vaccine adverse events in Singapore and also potentially help determine whether any specific patient groups may be at a higher risk of serious adverse events.
14 Oct 2009: Relenza® (zanamivir) Inhalation Powder must not be nebulized
GlaxoSmithKline (GSK) would like to notify healthcare professionals of the death of a patient with influenza who received Relenza ® (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation. The death was attributed to obstruction of the ventilator which could have been due to lactose in the formulation causing stickiness when the powder is mixed with the nebulizing solution. GSK would like to highlight to healthcare professionals that Relenza ® Inhalation Powder is not intended for reconstitution in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator, and also that Relenza ® or zanamivir for nebulization has not been approved by any regulatory authority and the safety, effectiveness and stability of zanamivir use by nebulization have not been established.
31 July 2009 : Update on neuropsychiatric adverse events suspected to be associated with oseltamivir (Tamiflu®)
The Health Sciences Authority (HSA) would like to update healthcare professionals on the local neuropsychiatric adverse events reported which were suspected to be associated with oseltamivir (Tamiflu®). The Pharmacovigilance Branch (PVB) recently received 3 local reports describing disorientation, incoherent speech, hallucination and suicidal attempt suspected to be associated with oseltamivir. Although it is unclear if the causality of these events is directly due to oseltamivir, HSA advises healthcare professionals to be aware of these neuropsychiatric events and to advise caregivers of young patients of the potential risk of these events.
15 Apr 2009 : Information on the association of erlotinib (Tarceva®) with gastrointestinal perforation, Stevens-Johnson syndrome and corneal perforation or ulceration [Roche]
Roche updates healthcare professionals on the increased risk of developing gastrointestinal perforations in patients receiving erlotinib (Tarceva®). Additionally, there have also been very rare occurrences of bullous, blistering and exfoliative skin conditions suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis as well as corneal perforation or ulceration in patients receiving Tarceva®. Tarceva® treatment should be discontinued in patients who develop gastrointestinal perforation, severe bullous, blistering or exfoliative skin conditions or acute/worsening ocular disorders such as eye pain.
12 Mar 2009 : Product Notification on Desferrioxamine Mesylate for Injection BP 500mg Freeze-Dried [Hospira] Hospira Singapore would like to notify healthcare professionals of a potential quality problem associated with Desferrioxamine Mesylate for Injection BP 500mg Freeze-dried. Hospira to date has received 26 complaints regarding the formation of fine precipitates after reconstitution of Desferrioxamine Mesylate for Injection BP 500mg since September 2008. None of the complaints were associated with adverse drug reactions.The formation of fine precipitates occurred either in the vial or after the reconstituted solution had been injected into the infusion device usually after 24 to 48 hours of storage, and within 24 hours in some cases. Hospira is conducting investigations into the cause of the precipitates in the desferrioxamine injection. Healthcare professionals are in the meantime, advised to adhere to the reconstitution guidelines provided in the letter and report adverse drug reactions suspected to be associated with the product to HSA.
26 Feb 2009: Sales of efalizumab (Raptiva®) suspended
The Health Sciences Authority (HSA) has requested for Merck Pte Ltd to suspend the sales of its product, Raptiva® in Singapore. HSA and its Pharmacovigilance advisory committee has reviewed the risk-benefit profile of Raptiva® and concluded that the benefits of Raptiva® in the treatment of plague psoriasis no longer outweigh its risks due to safety concerns including the occurrence of Progressive Multifocal Leukoencephalopathy (PML). Both EMEA and Health Canada have also recommended the suspension of the marketing authorization for Raptiva®. Patients who are taking Raptiva® should not stop treatment abruptly but consult their doctors as soon as possible to assess the most appropriate replacement treatment. Prescribers are advised not to issue any new prescriptions for Raptiva® and should review the treatment of patients currently taking the drug.
01 Jan 2009: Zelmac® tablet 6mg (tegaserod maleate) -Safety-related Package Insert Update [Novartis] Novartis updates healthcare professionals on the restriction of use of Zelmac® (tegaserod maleate) for Irritable Bowel Syndrome (IBS) with Constipation and Chronic Idiopathic Constipation to women below the age of 55. The rationale for this restriction is that cardiovascular (CV) ischaemic events observed in the pooled clinical trial database were primarily seen in patients with prior history of CV ischaemic disease or in patients with CV risk factors as defined by the American Heart Association and American College of Cardiology. Novartis is thus restricting the use of Zelmac® to women below 55 years so as to reduce a key controllable risk factor for ischaemic cardiovascular disease.
|
