Listing 

14 Dec 2005: Strengthening of labelling of promethazine-containing preparations for children under 2 years and new restriction to use in children less than 6 months old
Following the US FDA's decision to contraindicate the use of Phenergan® in children below 2 years old, HSA and the Pharmacovigilance Advisory Committee (PVAC) conducted a review of the risk-benefit profile of the drug when used in children. The review concluded that the risk of serious adverse drug reactions outweighs the potential benefits of the drug in young children.

14 Dec 2005: Important new safety data on suicidality risk associated with the use of Strattera® (atomoxetine) [by Eli Lilly]
Analysis of data found a small but statistically significant difference between atomoxetine and placebo in suicide-related behaviours in children and adolescents. Prescribing physicians should carefully monitor patients for appearance or worsening of suicide-related behaviour while on atomoxetine therapy.

05 Dec 2005: Letrozole (Femara®) and adverse outcome in babies following maternal exposure [by Novartis]
Novartis has issued a Dear Healthcare Professional Letter to alert healthcare professionals about its concern on the off-label use of letrozole (Femara®) even though prescribing information contains information about potential embryo- and fetotoxicity with or without teratogenicity, including contraindications for use in women with premenopausal endocrine status as well as in pregnancy and lactation.

09 Sep 2005: Caution regarding use of Seroxat® (paroxetine) in pregnancy
Preliminary findings of a retrospective epidemiology study sponsored by GSK suggest that the use of paroxetine is associated with an approximate 2-fold increase in risk of cardiovascular malformations and congenital malformations in infants born to women taking paroxetine during 1st trimester of pregnancy as compared to other antidepressants.

07 Jul 2005: Advisory on the regulatory control of medicinal products in Singapore
HSA advises medical and dental clinics to purchase medicinal products from licensed distributors or wholesalers. Importation of medicinal products into Singapore, for sale and supply, including those that are brought in by hand or through parcel post, would require appropriate licences or authorisation from HSA.

17 Jun 2005: HSA cautions against self-medication with medicines obtained from dubious sources
HSA has received five adverse drug reaction (ADR) reports involving the consumption of adulterated traditional medicines. The ADRs reported included blood disorders and liver injuries. The products adulterated were Jamu Kenis Pil, Jamu Pegal Linu, Kapsul Asam Urat, Ramuan Tradisional Madura and Snake Powder Capsule. Healthcare professionals are encouraged to enquire about complementary medicine use in their patients especially products that have been consumed in the recent three months when they suspect an ADR.

12 May 2005: Potential problem of falsely elevated blood glucose readings with Extraneal® (icodextrin) peritoneal dialysis solution
There have been recent adverse reports in Australia, Canada and the United Kingdom of injuries caused by falsely elevated blood glucose readings in diabetic patients who are using Extraneal® peritoneal dialysis solution that contains icodextrin as an ingredient and blood glucose monitoring systems that are based on the glucose dehydrogenase–pyrroloquinolinequinone (GDH-PQQ) method.

28 Apr 2005: HSA's expert advisory committee's recommendations on cyclooxygenase-2 (COX-2) selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs)
The expert advisory committee has reviewed the risk-benefit balance of COX-2 selective (e.g. celecoxib, etoricoxib, rofecoxib and valdecoxib) and non-selective NSAIDs.

08 Apr 2005: Pfizer's voluntary suspension of sales of valdecoxib (Bextra®)
Pfizer has voluntarily discontinued sales of Bextra® (valdecoxib) on 8 April 2005. Recent safety concerns have been raised about the cardiovascular (CV) safety of long-term use of Bextra® and increased risk of adverse CV events in patients who undergone short-term coronary artery bypass surgery (CABG). There were also reports of serious and potentially life-threatening skin reactions (e.g. toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme), including deaths, in patients using Bextra®.

30 Mar 2005: Deregistration of thioridazine products with effect from 31 March 2006
HSA will deregister all brands of thioridazine with effect from 31 March 2006. The risk-benefit balance of thioridazine is unfavourable because of the increased risk of serious cardiac arrhythmias, and the availability of alternative antipsychotics. Physicians are advised not to prescribe the drug to new patients and to consider switching patients currently on thioridazine to alternative medications.

14 Mar 2005: Safety concerns associated with use of erythropoietins (EPOs) in cancer patients
There are two EPOs currently registered in Singapore: epoetin alfa (Eprex®, Johnson & Johnson) and epoetin beta (Recormon®, Roche). Recent emerging safety concerns of the possibility that some clinical uses of EPOs in patients with cancer may be associated with unanticipated risks, including an increased risk of thrombotic vascular events and/or an adverse effect on tumour progression and duration of survival. Based on the risk-benefit assessment of EPOs in cancer patients, the Pharmacovigilance Advisory Committee recommended that the licensed indication of EPOs for prevention of anaemia in cancer patients is no longer appropriate.
 
07 Mar 2005: Changes to Seroxat® (paroxetine) labeling [by GlaxoSmithKline]
Product labelling of Seroxat® (paroxetine) was updated following recent reviews of selective serotonin reuptake inhibitors. The changes include warnings on adverse events related to suicidality (suicide attempts and suicidal thoughts) and hostility in paediatric patients treated with paroxetine.