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Dear Healthcare Professional Letters (DHCPL) in 2010

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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
 
30 December 2010: Voluntary recall of Medisense® OptiumTM Blood Glucose Test Strips and OptiumTM Point-of-Care Blood Glucose Test Strips
Abbott Diabetes Care, a division of Abbott Laboratories (S) Pte. Ltd., in consultation with Health Sciences Authority (HSA), announces a voluntary recall of 24 lots of 2 different presentations of blood glucose test strips sold in Singapore - MediSense® Optium™ and Optium™ Point-of-Care Blood Glucose Test Strips. This recall was initiated as the test strips
were found to give a falsely low blood glucose reading. Healthcare professionals are advised to stop the use or supply of affected strips.
 
 
29 December  2010:  Voluntary Recall of Care Wipes, Trihexid Chlorhexidine Mouth Rinse & Pearlie White Fluorinze Fluoride Mouth Rinse
The Health Sciences Authority (HSA) would like to alert healthcare professionals on the voluntary consumer level recall by the companies of the following health products which were  found to be contaminated with Burkholderia cepacia (B. cepacia), a gram-negative bacillus.
• “Care Wipes” (a disposable skin cleansing wipe)
• “Trihexid Chlorhexidine 0.2% Mouth Rinse”
• “Pearlie White Fluorinze Fluoride Mouth Rinse”                                                             
The contamination of the 3 products was detected following HSA's stepped up quality compliance testing of health products. For further information or clarification on the recall of the affected products, please refer to the contact details made available in the Dear Healthcare Professional Letter.
 
 
7 December  2010:  Recall of Aqualift™ Dermal Filler
The Medical Device Branch (MDB) of the Health Science Authority (HSA) would like to inform healthcare professionals on the recall of Aqualift™ Dermal Filler by Celeste (S) Pte. Ltd. HSA has been informed of a probable adverse event suspected to be related to the dermal filler. While investigations are still on-going, physicians who have existing stocks of the Aqualift™ Dermal Filler are advised to stop using it immediately and to monitor any patients who have received such treatment. HSA has instructed Celeste (S) Pte Ltd to recall the product from the market.                                                                                                                                                                                                                                                                                                                      
In addition, the Medical Device Branch of HSA will be updating the list of medical devices applications that have been rejected due to safety concerns on the HSA website.     
       
 
29 November 2010: Caution against use of quinine in nocturnal leg cramps
Beacons Pharmaceuticals would like to inform healthcare professionals about labelling updates for Quinine Sulphate 300mg Tablets. Due to the potential risk of serious haematological reactions associated with the use of quinine sulphate, the product insert has been updated to include warnings and precautions against the off-label use of quinine in the treatment or prevention of nocturnal leg cramps as the potential risks outweigh the benefit of this treatment. Other labelling updates include additional warnings on the risk of quinine-induced thrombocytopenia, development of hypersensitivity and an updated list of possible adverse reactions associated with use of quinine sulphate.
 
 
16 November 2010: Voluntary Recall of “Oral Guard Antiseptic-Antiplaque Mouthwash”
The Health Sciences Authority (HSA) would like to update healthcare professionals on the voluntary consumer level recall of all batches of “Oral Guard Antiseptic-Antiplaque Mouthwash” which was found to be contaminated with Burkholderia cepacia (B. cepacia), a gram-negative bacillus. The recall was initiated as a precautionary measure as the contaminated product may pose a health risk to susceptible individuals. Healthcare professionals are advised to stop prescribing “Oral Guard Antiseptic-Antiplaque Mouthwash” to patients and encouraged to be vigilant to possible adverse effects which may arise from the use of the contaminated mouthwash, especially in individuals who are immunocompromised or have chronic lung diseases.
 
 
19 October 2010: Recall of Velocity™ Injection Port and Applier (PT2XV), SAGB Quick Close Swedish Adjustable Gastric Band including Velocity™ Injection Port and Applier (BD2XV) and SAGB VC Swedish Adjustable Gastric Band including Velocity™ Injection Port and Applier (BD23XV)
Ethicon Endo-Surgery, is initiating a voluntary recall of the SAGB Quick Close Swedish Adjustable Gastric Band including Velocity™ Injection Port and Applier AND the SAGB VC Swedish Adjustable Gastric Band including Velocity™ Injection Port. The recall of the Swedish Adjustable gastric band is due to reports of the band's Strain Relief sliding out of its intended position. When this happens, the Strain Relief no longer aids in preventing kinking at the point where the tubing connects to the port. If the catheter tube becomes separated from the Injection Port, it is possible that there could be saline leakage through the tubing and the Strain Relief component could become a free foreign body within the abdomen, which may require additional surgical intervention.Surgeons are recommended to check for the patency of the tube and positioning of the Strain Relief component in existing patients
 
 
14 October 2010: Rhinathiol 2% (carbocisteine) Children and Infant Syrup - Contraindication in children below 2 years old 
Sanofi-Aventis Singapore Pte Ltd is informing healthcare professionals that they will be adopting the French authorities' decision to contraindicate the use of Rhinathiol 2% Children and Infant syrup in children below 2 years of age. This decision arose from the French Regulatory Agency's (Afssaps) evaluation of pharmacovigilance data which indicated the risk of aggravation of respiratory symptoms in connection with the use of mucolytic products to treat bronchial secretion in children below 2 years old. This led the French authorities to conclude that the benefit risk ratio of mucolytic products in children less than 2 years of age is no longer favourable and the contraindication of these products in this group of children is required as a precautionary measure. The local package insert for Rhinathiol 2% Children and Infant syrup will be updated to reflect this new contraindication. The packaging will subsequently be changed and renamed as Rhinathiol 2% Children Syrup. The new packaging with the revised package insert is estimated to be implemented in Singapore in February 2011.
 
 
13 October 2010: Suspension of sales of Reductil®, Ectiva® and Reduxade® in Singapore
Abbott Laboratories (S) Pte Ltd is informing healthcare professionals of the suspension of sales of Reductil®, Ectiva® and Reduxade® from the Singapore market at the request of HSA. HSA's decision to suspend sibutramine took into consideration the results of the SCOUT (Sibutramine Cardiovascular Outcomes) study, the use of sibutramine in the local context and the developments in other international jurisdictions. SCOUT study is an approximately 10,000 patient, six-year study requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients. Patients treated with sibutramine experienced a 16% increased risk of a primary outcome event of non-fatal myocardial infarction, non-fatal stroke, resuscitated cardiac arrest, or cardiovascular death compared with placebo-treated patients. This result was attributed to an increased risk of non-fatal myocardial infarction and stroke.
 
 
11 October 2010: Suspension of  sales of  Sibutramine
The Vigilance Branch of HSA would like to update healthcare professionals on its regulatory decision to suspend the sales of sibutramine products with effect from 11 October 2010 following a benefit-risk assessment, which took into consideration the findings from the Sibutramine Cardiovascular Outcomes (SCOUT) study, the use of the product in the local context and developments in other international jurisdictions. The Vigilance Branch had consulted with its Pharmacovigilance Advisory Committee and a panel of external experts before arriving at this regulatory decision.
 
 
30 September 2010: Product Recall: Peg-Intron® REDIPEN Injection
SOL Limited (Singapore Branch), a subsidiary of Merck& Co. Inc, is conducting a voluntary recall, to the pharmacy/retailer level, of all strengths of Peg-Intron® REDIPEN Injection as a precautionary measure due to a potential defect in the glass cartridge component of the product delivery system.  As a result of this defect, a limited number of REDIPEN units may have a potential risk for contamination since the container seal may be compromised.  With effect from 18 Sept 2010, all sales of Peg-Intron® REDIPEN Injections have been suspended and all existing stocks of all the affected batches will be recalled. Until unaffected units of Peg-Intron ® REDIPEN become available, healthcare professionals are advised NOT to initiate Peg-Intron ® treatment on NEW patients and to consider switching existing patients to alternative therapies.
 
 
24 September 2010: HSA's advisory on the use of rosiglitazone
The Health Sciences Authority (HSA) has reviewed the  recent scientific analyses conducted to determine the cardiovascular (CV) risk associated with the use of rosiglitazone (Avandia®) and concluded on its recommendations on the use of rosiglitazone. Based on the data reviewed and the recommendations of the Pharmacovigilance Advisory Committee and the expert panel of endocrinologists and cardiologists, HSA has assessed that a possible increased risk of myocardial ischaemic events associated with rosiglitazone cannot be excluded. However, for a group of patients who cannot effectively control their blood sugar using alternative medications, the benefits of rosiglitazone may exceed these risks. Hence, additional contraindications and restrictions would be implemented to mitigate any possible CV risks associated with the use of rosiglitazone.
 
 
6 September 2010: Important safety information regarding Actemra® (Tocilizumab) and anaphylaxis
Roche would like to inform healthcare professionals of a post-marketing case of fatal anaphylaxis reported in the USA, in a patient with rheumatoid arthritis treated with Actemra®. The patient was a 67-year old woman who died from an anaphylactic event after her fifth infusion of Actemra® despite prompt medical intervention. This is the first reported case of fatal anaphylaxis in a patient treated with Actemra®. The diagnosis of hypersensitivity or anaphylaxis should be considered in any patient experiencing an infusion reaction during or following Actemra® administration. If an anaphylactic or other serious hypersensitivity reaction occurs, administration of Actemra® should be stopped immediately. Appropriate medical management should be initiated, and Actemra® should be permanently discontinued. 
 
 
31 August 2010: The recall of the DePuy ASR™ Articular Surface Replacement and ASR™ XL Acetabular System
DePuy Othopaedics, a subsidary of Johnson&Johnson is initiating a voluntary recall of the DePuy ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System. The recall was initiated due to recent data from the National Joint Registry (NJR) of England and Wales showed that the 5 year revision rate for the ASR™ Hip Resurfacing System was approximately 12% and for the ASR™ XL Acetabular System was approximately 13%. These revision rates were across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patients.Because these recent findings, DePuy has decided to issue a voluntary recall of all ASR products. Clinicians are advised NOT to implant the ASR devices.
 
 
2 July 2010: Recall of a defective batch of Implanon implant containing Etonogestrel
SOL Limited (Singapore Branch), a subsidiary of Merck & Co., is recalling all unused units of Implanon units from batch No.: 476471/434216 with effect from 2 July 2010 due to a manufacturing defect that  lead to increased resistance in retracting the applicator cannula. The product defect is a mechanical deficiency in the applicator and has no effect on the implant itself. In the affected units, difficulties or inconvenience may be experienced during the insertion procedure. The risk to patient is assessed to be minimal. Prescribers are advised to immediately cease the use of this affected batch. Arrangements will be made by the company for the replacement of the Implanon units from the defective batch.
 
 
7 June 2010: Important update regarding imiglucerase (Cerezyme®)
Genzyme informs healthcare professionals of trace amount of 2,4-dichlorobenzoic acid (2,4-DCBA) in some vials of Cerezyme® filled at the Waterford, Ireland facility. Investigations and root cause analysis identified the source to be a leachable from the peroxide-cured silicone tubing used at the Waterford filling line. Through investigations and safety database review, Genzyme concluded that the likelihood of 2,4-DCBA being present in Cerezyme® is extremely low and risk to patient safety is low. As part of Genzyme's corrective action plan, the peroxide-cured tubing was replaced with new tubing that does not contain 2,4-DCBA on 25 Feb 2010. While prior lots of Cerezyme® shipped to Singapore may have traces of 2,4-DCBA, future patient exposure to 2,4-DCBA has been eliminated by replacing lots of Cerezyme® with lots manufactured using the new tubing.
 
 
7 June 2010: Important update regarding anti-thymocyte globulin (Thymoglobuline®)
Genzyme informs healthcare professionals of the potential presence of trace amount of 2,4-dichlorobenzoic acid (2,4-DCBA) in some vials of Thymoglobuline® injection filled at the Waterford, Ireland facility. Investigations and root cause analysis identified the source to be a leachable from the peroxide-cured silicone tubing used at the Waterford filling line. Through investigations and safety database review, Genzyme concluded that the likelihood of 2,4-DCBA being present in Thymoglobuline® is extremely low and risk to patient safety is low. As part of Genzyme's corrective action plan, the peroxide-cured tubing was replaced with new tubing that does not contain 2,4-DCBA on 25 Feb 2010. Affected batches of Thymoglobuline® available locally will be replaced with product manufactured using the new tubing by mid Jun 2010.
 
 
31 May 2010: Updates on the Colleague Infusion Pumps in Singapore
Baxter is updating healthcare professionals on the status of the Colleague Infusion Pumps in Singapore.  The US FDA has recently recalled all Colleague Infusion Pumps currently in use in the US due to a continuing failure to correct the deficiencies with this class of pumps. However, the Colleague Infusion Pumps marketed in Singapore have device configurations that are 1 to 2 versions ahead of the models recalled in the US. Baxter is currently developing the latest P1.7 configuration software and hardware upgrade for all Colleague Infusion Pumps marketed locally and expects its deployment in the fourth quarter in 2010. In the meantime, healthcare professionals are advised to report all failures, problems and adverse events associated with the use of these pumps to Baxter Healthcare.
 
 
27 May 2010: Association of WinRho® SDF (Rho(D) Immune Globulin (Human) with Intravascular Hemolysis (IVH) in the treatment of Immune Thrombocytopenic Purpura (ITP)
Pharmaforte updates healthcare professionals on the risk of IVH and its complications with WinRho® SDF when used in ITP. IVH can lead to severe anaemia and multi-organ failure including acute respiratory distress syndrome. From March 1995 to March 2009, 180 cases of IVH with WinRho® SDF have been reported worldwide. A disproportionate number of IVH cases were reported in patients with ITP secondary to hematological malignancies (leukemia or lymphoma) or active viral infections with HCV and EBV. Elderly patients with co-morbidities are more likely to experience renal and cardiovascular complications including fatal outcomes, from hemolysis. Physicians are encouraged to discuss the risks and benefits of WinRho® SDF and to alert patients about the signs and symptoms of IVH.
 
   
18 May 2010 : Recommendations on the use of rotavirus vaccines- Rotarix® and RotaTeq® in Singapore
The Health Sciences Authority (HSA) has earlier informed healthcare professionals on the findings of DNA fragments of porcine circovirus 1 (PCV1) in Rotarix® and PCV1 and porcine circovirus 2 (PCV2) DNA fragments in RotaTeq®. HSA, in consultation with the MOH and its Expert Committee on Immunisation (ECI), would like to update healthcare professionals that they can continue to use Rotarix® and RotaTeq® as the benefits of vaccination outweigh the risk of PCV infectivity. Healthcare professionals can continue to use Rotarix® in patients who have previously deferred vaccination. Patients who have started or have been switched to the RotaTeq® vaccination schedule may wish to complete their course of vaccination with RotaTeq®. Parents should be made aware of the presence of the PCV DNA in these vaccines so that they can make an informed decision before their child is vaccinated.


11 May 2010 : Inappropriate use of and medication errors associated with Exelon® Patch (rivastigmine transdermal patch)
Novartis would like to remind healthcare professionals of the importance of the proper use and application of Exelon® Patch (rivastigmine transdermal patch). Medication errors and inappropriate use of Exelon® patch have been reported, some of these resulting in rivastigmine overdose. Symptoms of overdose include nausea, vomiting, diarrhoea, hypertension, and hallucinations. The most frequent reported causes are lack of patch removal and application of more than one patch at the same time. Serious medical outcomes, including death, may occur if the medication errors and misuse are not corrected in a timely manner and properly managed. In case of overdose, all Exelon® patches should be immediately removed. Healthcare professionals are advised to refer to the product information for the use of the product and to educate patients/ caregivers on the proper use of Exelon® Patch prior to initiating therapy. A copy of the updated product information will be made available on HSA website.
 
 
14 Apr 2010 : The association of isotretinoin (Roaccutane®) with severe skin reactions (erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN))
Roche would like to inform healthcare professionals about post-marketing reports of severe skin reactions (e.g., erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN)) associated with isotretinoin (Roaccutane®) use. These events may be serious and result in hospitalization, disability, life threatening events, or death. Patients should be monitored closely for severe skin reactions and discontinuation of Roaccutane® should be considered if warranted.
 
 
1 Apr 2010 : Post-marketing reports of renal impairment associated with zoledronic acid 5mg solution for infusion (Aclasta®)
Novartis would like to update healthcare professionals on post-marketing reports of renal impairment following administration of Aclasta®. As of 14 Aug 09, there have been 139 reports of renal impairment, corresponding to a reporting rate of 18 cases per 100,000 patient-years. Majority of the cases were reported in patients with pre-existing medical conditions, risk factors (advanced age, renal impairment, concurrent or preceding dehydration), or with concurrent exposure to nephrotoxic agents. Rare cases of renal failure requiring dialysis or with fatal outcomes have also been reported. Physicians are advised to consider thoroughly their patient's renal function before initiating Aclasta® and not to use it in patients with severe renal impairment (CrCl < 35ml/min). Physicians are encouraged to consult the updated Aclasta® package insert available on HSA website before prescribing it to patients.
 
 
23 Mar 2010 : Update on the recent finding of porcine circovirus-1 (PCV-1) DNA fragment in rotavirus vaccine (Rotarix®)
The Health Sciences Authority (HSA) would like to update healthcare professionals on the recent findings by researchers from the University of California, San Francisco regarding the presence of DNA fragment of porcine circovirus (PCV-1) found in the rotavirus vaccine, Rotarix® (GSK) and HSA's interim position on this matter.
 
An independent research team from the University of California, San Francisco, has identified a DNA fragment of porcine circovirus 1 (PCV-1) in Rotarix®. The PCV-1 DNA fragment has been incorporated into the vaccine during  the manufacturing process. Based on the available information from clinical trials and  the post-marketing surveillance data, there is no evidence at this time that this finding poses a safety risk.The Vigilance Branch has also not received any local adverse event  reports associated with rotavirus vaccines which appear to be related to this issue. While HSA is reviewing the significance of this finding, healthcare professionals are advised to consider deferring  immunisation with Rotarix® or consider an alternative vaccine till more information becomes available.
 
 
18 Mar 2010 : The association of bevacizumab (Avastin®) with hypersensitivity reactions and infusion reactions
Roche would like to update healthcare professionals on the risk of patients experiencing hypersensitivity reactions or infusion reactions after receiving bevacizumab (Avastin®). From the review of 13 controlled clinical trials involving more than 8,400 patients, Roche noted imbalances in hypersensitivity and infusion reactions among patients treated with Avastin® and chemotherapy in some clinical studies. A cumulative search of Roche's safety database also identified seven cases of positive re-challenge and two cases with positive cutaneous test amongst 273 reports of hypersensitivity retrieved, though it has been noted that majority of the cases were confounded by concomitant chemotherapy. Physicians are advised to closely monitor patients during and after Avastin® infusion and to stop the infusion and administer appropriate therapies if a reaction occurs.
 
 
20 Jan 2010 : Changes to the prescribing recommendation for therapeutic drug monitoring of Rapamune®  (sirolimus)
Wyeth would like to inform healthcare professionals that switching between platforms for therapeutic drug monitoring of sirolimus, whether between immunoassay platforms or between immunoassay and HPLC, can produce differing results that may be clinically significant. Hence, if different assays are used in monitoring a single patient without the knowledge of the prescriber, the dose of Rapamune might be adjusted improperly with potential consequences, such as allograft rejection if drug exposure is too low or toxic side effects if exposure is too high. Wyeth is working with HSA to update the prescribing recommendation for therapeutic drug monitoring of Rapamune ® (sirolimus), based on the above findings. Wyeth is also advising all healthcare professionals involved in the management of patients taking Rapamune to determine the type of assay used in their laboratory(ies) and to note any changes to the assay and corresponding reference range used.
 


Last updated on 03 Dec 2013 16:24:15
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