Here are some safety advisory and news for your speed update.
•    Recall of Panvax® Junior H1N1 Vaccine in Singapore
•    Recall of 1 Day Acuvue® TruEye™ Brand Contact Lenses
•    Bupivacaine (Marcain®) & reports of lack of efficacy
•    Zoledronic acid (Aclasta®) & reports of renal impairment
•    Orlistat and reports of severe liver injury
•    Haemolysis associated with WinRho® SDF injection

•    Recall of Panvax^® Junior H1N1 Vaccine in Singapore
On 27-Aug, the MOH and HSA have jointly issued an update to the public on the voluntary recall of Panvax® Junior H1N1 vaccine (CSL Limited) in Singapore with immediate effect. The recall is a precautionary measure taken as a result of the findings by the Australia Therapeutic Goods Administration (TGA) on the decline in the potency of this product in Australia based on ongoing stability tests. Full info can be found here .

•    Recall of 1 Day Acuvue^® TruEye™ Brand Contact Lenses
On 20-Aug, the HSA is overseeing the voluntary market recall of affected lots of of 1•DAY ACUVUE® TruEyeTM Brand Contact Lens by Johnson & Johnson Vision Care. This recall was initiated on Thursday 19 August 2010, due to overseas reports of eye irritation or discomfort as a result of using this product. For details about affected batches & advice for patients, please read the full press release issued by HSA here .

•    Bupivacaine (Marcain^®) and reports of lack of efficacy
The HSA has from September 2009 to March 2010, received a clustering of reports on the lack of efficacy associated with the use of bupivacaine preparations (Marcain® 0.5% and Marcain® Spinal 0.5% Heavy Injection, AstraZeneca, AZ) when used during spinal anaesthesia. Analytical test results conducted on the affected batches indicated that the products were within the registered product specifications and that the products were stable during the specified shelf-life. Based on available literature and investigations conducted to date, HSA has assessed that the causes of failed spinal anaesthesia could be a combination of many factors. Global estimates on the incidence of failed spinal anaesthesia range from 0.5 – 17%. HSA will continue to monitor this situation and update our healthcare professionals when new information arises. More info here.

•    Zoledronic acid (Aclasta^®) and rare reports of renal impairment
On 16-Aug, HSA would like to bring to the attention of healthcare professionals, post-marketing reports of renal impairment and renal failure associated with the use of intravenous zoledronic acid (Aclasta®). As of 14 August 2009, 139 post-marketing reports of renal impairment following Aclasta® infusion have been received by Novartis worldwide. Majority of these cases have been reported in patients with pre-existing medical conditions or risk factors or who had concurrent exposure to nephrotoxic agents. Rare cases of renal failure requiring dialysis or with a fatal outcome have been reported in patients with pre-existing renal impairment and concomitant risk factors. To date, HSA has received two reports of renal-related adverse reactions following Aclasta® infusion. One patient experienced acute renal failure and another patient on multiple concomitant medications developed renal impairment nine months after receiving Aclasta® infusion. Physicians are advised to consider their patient's renal function and assess their patient's serum creatinine before treatment with Aclasta® in view of the above safety information. More info here.

•    Orlistat and reports of severe liver injury
On 16-Aug, HSA is updating healthcare professionals on the post-marketing reports of liver injuries associated with the use of orlistat. Orlistat is registered in Singapore under the trade names of Alli® (GSK) and Xenical® (Roche). US FDA recently reviewed 13 reports of severe liver injury, which occurred over a period of 10 years, associated with the use of these orlistat-containing medicines. Of these 13 patients, two died from liver failure while three patients required liver transplantation. FDA reported that a causal relationship between severe liver injury and the use of orlistat has not been established. Moreover, some of these patients were on concomitant medications and have confounding medical conditions. A Europe-wide review also concluded that there was insufficient evidence to show that either Xenical® or Alli® was associated with serious liver disorders. Since 2000, HSA has received a case of jaundice and fulminant liver failure with massive hepatocellular necrosis and another case of elevated liver enzymes associated with the use of Xenical®. In view of the potential for rare but severe liver injuries, healthcare professionals are advised to consider the benefits and risks associated with the use of orlistat before prescribing orlistat and to advise patients to stop the use of orlistat and seek prompt medical attention if they experience symptoms associated with liver injury. For more info, please click here .

•    Haemolysis associated with WinRho^® SDF injection
HSA would like to bring to the attention of healthcare professionals the potential risk of intravascular haemolysis (IVH) associated with Rho (D) Immune Globulin (Human) (WinRho® SDF) when used to treat Immune Thrombocytopenia Purpura (ITP). From March 1995 to March 2009, the manufacturer reported a total of 180 serious post-marketing reports of suspected and/or confirmed cases of IVH associated with the use of WinRho® SDF worldwide. Seventeen of the 58 definite IVH cases (29%) reported fatal outcomes. A disproportionate number of IVH cases has also been reported in patients with ITP secondary to haematological malignancies or active viral infections. The local package insert (PI) for WinRho® SDF has been updated to include new contraindications and monitoring information. Physicians are advised to be vigilant for signs and symptoms of IVH, including back pain, shaking chills, fever, and discoloured urine or haematuria in patients being treated with WinRho® SDF. For full info, please click here .

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