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/.
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Listing
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.
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.
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.
Pharmaforte wishes to update 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.
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