1 Dec 2008: Abacavir hypersensitivity reactions associated with HLA-B*5701 allele
HSA informs healthcare professionals that results from two studies, PREDICT-1 and SHAPE, have shown that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with the human leukocyte antigen (HLA) allele, HLA-B*5701. The strong association between HLA-B*5701 allele carriage and abacavir HSR and the recommendation to do pre-therapy HLA-B*5701 screening have been updated in the US and European package inserts for abacavir-containing products. Although our Asian population has a low prevalence of the HLA-B*5701 allele, it is important for prescribers to bear in mind the potential risk of abacavir HSR associated with this allele.
1 Dec 2008: Haemorrhagic or necrotizing pancreatitis associated with Byetta®
The US FDA issued a safety alert to warn healthcare professionals of the potential risk of acute pancreatitis associated with Byetta®, following its review of the 30 post-marketing reports of acute pancreatitis in patients treated with Byetta®. With the recent 6 cases of haemorrhagic or necrotizing pancreatitis, FDA has requested the company to add stronger and more prominent warnings in the package insert about the risk of acute haemorrhagic or necrotizing pancreatitis. Healthcare professionals are encouraged to advise their patients taking Byetta® to look out for signs and symptoms of acute pancreatitis and to seek prompt medical attention should they experience unexplained, persistent, severe abdominal pain, which may be accompanied by nausea and vomiting. If pancreatitis is suspected, Byetta® should be discontinued.
1 Dec 2008: Slimming health products (Relacore & Lami) adulterated with sibutramine
In recent months, the Pharmacovigilance Branch, HSA has received 3 reports of adverse drug reactions (ADR) associated with 2 slimming health products. On further investigation, the products namely, ‘Relacore' and ‘Lami', were found to contain sibutramine, an undeclared western drug ingredient used as an appetite suppressant in the management of obesity. Given the increasing trend of consumers turning to the Internet for purchase of health products, healthcare professionals are encouraged to ask patients about the consumption of such complementary medicines or health supplements.
1 Dec 2008: Fentanyl transdermal patch and overseas reports of fatality
HSA would like to update healthcare professionals on the overseas cases of life-threatening and fatal adverse events reported with the use of fentanyl transdermal patch. Reports of life-threatening adverse reactions and death have been received by the UK MHRA, Health Canada and US FDA associated with the inappropriate use, abuse and overdose (both unintentional and intentional) of the product. Due to the seriousness and occurrence of fatalities associated with the inappropriate use and abuse of the patch reported overseas, healthcare professionals are advised to be aware of the potential serious and fatal adverse effects associated with the use of fentanyl patches.
2 Jul 2008: Adulterated illegal sexual enhancement products
HSA's recent investigations involving Power 1 Walnut and several other illegal sexual enhancement products found adulterated with toxic doses of glibenclamide is the most serious case of adverse dug reactions to illegal health products that we have encountered, involving 47 cases of adverse drug reactions (e.g. hypoglycaemia) confirmed to be due to the products and 98 suspect cases. In addition to Power 1 Walnut, the other three illegal health products found to contain glibenclamide are counterfeit Cialis, Santi Bovine Penis Erecting Capsule and 中華牛鞭 (Zhong Hua Niu Bian).
HSA looks forward to continue working together with healthcare professionals to ensure that drugs and health products on the market are safe for the local population.
2 Jul 2008: Tumor necrosis factor-alpha antagonists (adalimumab, etanercept and infliximab) and serious skin reactions
HSA informs healthcare professionals about adverse drug reaction reports of serious cutaneous adverse reactions associated with the use of adalimumab, etanercept and infliximab received by the US Food and Drug Administration (FDA). The adverse reactions, from both domestic and overseas reports include erythema multiforme (EM), Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The local package insert will be updated to reflect these recent post-marketing findings.
2 Jul 2008: Update on aprotinin (Trasylol®)
HSA has suspended the local sales of aprotinin in November 2007 and restricted its access to patients based on interim findings of the the Blood Conservation Using Antifribinolytics Randomized Trial (BART) that compared the use of aprotinin against lysine analogues, tranexamic acid and aminocaproic acid, conducted by the Ottawa Health Institute in Canada on 2,331 high risk cardiac surgery patients from August 2002 to October 2007. Recently, the evaluation of this trial has concluded and the findings revealed that high-risk cardiac surgery patients using aprotinin had fewer incidents of massive bleeding as defined by the investigators but had a higher 30-day mortality when compared with the other patients given tranexamic acid or aminocaproic acid. HSA reminds physicians to discuss the risks associated with the use of aprotinin and obtain written consent from the patient or next of kin before prescribing aprotinin.
2 Jul 2008: Withdrawal of indication of primary nocturnal enuresis for all desmopressin nasal preparations
HSA informs healthcare professionals of the recent request by UK Medicines and Healthcare products Regulatory Agency and the US Food and Drug Administration (FDA) to the companies marketing desmopressin products in their respective countries to remove the indication for the treatment of primary noctural enuresis (PNE) from all their nasal preparations. This was due to concern of a higher incidence of hyponatraemia reported with desmopressin nasal preparations compared to oral preparations when used for the treatment of primary nocturnal enuresis. HSA will also be working with the product lincence holders of desmopressin to ensure the prescribing information is updated to highlight this safety information.
2 Jul 2008: Clozapine-induced gastrointestinal hypomotility
HSA brings to the attention of healthcare professionals, a study recently published (online ahead of print) in the Journal of Clinical Psychiatry, to raise awareness of a rare but potentially lethal clozapine-induced gastrointestinal hypomotility (CIGH). Even though it is known that clozapine can affect the entire digestive system causing esophageal to rectal hypomotility, the authors emphasized the need to prevent and manage CIGH-related constipation as it can result in bowel obstruction, ischaemia and necrosis, perforation, and aspiration pneumonia.
2 Jul 2008: PDE5 inhibitors (sildenafil, vardenafil and tadalafil) associated sensorineural hearing loss
There has been a recent warning released by the US FDA of a reasonably plausible temporal relationship of sudden sensorineural hearing loss (SSHL) with the use of sildenafil, tadalafil and vardenafil. This warning was based on 29 post-marketing cases that occurred with patients on sildenafil (19 cases), tadalafil (5 cases) and vardenafil (5 cases). In approximately one-third of the cases, the hearing loss was temporary, with majority of the cases reporting onset of SSHL within 24 hours of PDE5 inhibitors use. The local package inserts are being revised to reflect the warning on hearing loss. Physicians should advise their patients to seek prompt medical attention if they experience sudden decrease or loss of hearing.
2 Jul 2008: Updates on the mycophenolate group of drugs
Based on a publication by Sifontis et al, post-marketing data from the US National Transplant Pregnancy Registry (NTPR), and mycophenolate mofetil MMF worldwide adverse event reporting, use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations. External ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, oesophagus, and kidney were the main congenital malformations observed.
2 Jul 2008: Varenicline (Champix®) and neuropsychiatric adverse events
The US Food and Drug Administration (FDA) and Health Canada has received post-marketing adverse event reports describing serious neuropsychiatric symptoms, including changes in behaviour, agitation, depressed mood, suicidal ideation and suicide since varencline was introduced to US and Canada in May 2006 and April 2007 respectively. The product label for varenicline in the US, Canada and Europe have been updated to include warnings on these neuropsychiatric adverse events. Although HSA has not received any local adverse reaction reports associated with Champix® since it was launched locally in April 2008, we are working with Pfizer (Singapore) to develop a patient medication guide for patients taking the medication with the aim of providing information on possible adverse reactions associated its use so that patients can identify these reactions and seek medical help if they experience these effects.
25 Mar 2008: Update on rosiglitazone and cardiovascular risks
Based on the available data to-date, there is insufficient evidence at this point to conclude that the risks of myocardial infarction and cardiovascular death is higher for rosiglitazone compared to other type 2 diabetes treatments. However, to enhance safer use of this drug, the prescribing information in the package inserts of Avandia® and Avandamet® will include information on cardiac ischaemia in the adverse reactions and clinical studies sections of the package insert, and the initiation of rosiglitazone will be contraindicated in patients with NYHA Class III and IV heart failure.
25 Mar 2008: Strontium (Protos®) - A safety update
There has been a concern of reports of drug rash with eosinophilia and systemic symptoms (DRESS) associated with the use of Protos®. As of November 2007, 16 cases of DRESS were reported to the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP). The latency period between the first ingestion of Protos® and the display of symptoms of DRESS is about 3 to 6 weeks. All of the cases were classified as severe and required hospital treatment. Two of the patients died.
In light of the post-marketing reports described above, the CHMP concluded that the use of Protos® is linked to an increased risk of DRESS and recommended that warnings on severe hypersensitivity syndromes, including DRESS and Stevens Johnson syndrome be included in the product and patient information for Protos®.
25 Mar 2008: Suicidality associated with antiepileptic drugs
HSA would like to inform healthcare professionals about the recent findings of the US Food and Drug Administration (FDA) on the increased risk of suicidal thoughts and behaviour associated with antiepileptic drugs (AEDs) from the analysis of 199 placebo-controlled clinical trials. This analysis was triggered by a preliminary finding in March 2005 that several drugs in this class were associated with an increased risk of suicidality.
25 Mar 2008: Update on suspension of sales of nimesulide in Singapore
In June 2007, HSA suspended the local sales of nimesulide-containing oral preparations pending the safety review of nimesulide following both local and overseas signals of liver toxicities.
HSA completed the review of available data, which comprised of local adverse drug reaction reports, the WHO international adverse drug reactions database, literatures, EMEA's review and local consumption data of the product in December 2007. The review concluded that the risks versus benefits profile of nimesulide is unfavourable thus the sales of oral preparations containing nimesulide will remain suspended and the product licences of Nidol® tablet, Nidol® satchet, Nimotas-CD® Ttablet, Nise® tablet and Qnim MD® tablet will not be renewed upon expiry.
25 Mar 2008: Update on Evra® and thromboembolism
This is an update on the further findings from the recently completed studies reviewing the relative risk of venous thromboembolism (VTE) associated with use of Ortho Evra® compared to combined oral contraceptives (COC). The package insert of Evra® has been amended to include the findings of the latest epidemiology studies on Ortho Evra®.
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