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Author Topic: EMA and USFDA concern on the use of Rosiglitazone:NAFDAC takes stricter measures  (Read 2834 times)
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Francis Umeoguaju
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« on: December 25, 2010, 03:58:50 pm »


The recent regulatory actions by the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA) regarding Rosiglitazone-containing medicines marketed by GlaxoSmithKline (GSK) have raised concerns on its continued use in Nigeria. While the EMA has suspended the marketing authorizations for the rosiglitazone-containing medicines Avandia, Avandamet and Avaglim, the USFDA has significantly restricted the use of rosiglitazone to Type 2 diabetic patients who cannot control their diabetes on other medications.
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These disparate actions follow recent reviews of outcomes of new studies which question the cardiovascular safety of rosiglitazone. Since it was first granted marketing authorization, the medicine has been associated with fluid retention and increased risk of heart failure, thus its cardiovascular safety has always been kept under close review.
 
Rosiglitazone is marketed in Nigeria by GSK as Avandia tablets containing 8mg, 4mg and 2mg rosiglitazone (RSG) maleate and avandamet tablets containing 2mg RSG + 500mg metformin and 4mg RSG + 500mg metformin.  Rosiz-Mt which is the brand name for 2mg RSG + 500mg metformin previously marketed by Fil Pharmaceuticals is no longer being imported by the company.
In Nigeria, only one ADR report involving bilateral leg swelling and peri-orbital swelling has been reported to the NPC since the product was first granted marketing authorization in 2002. Consequently, after interaction between the MAH in Nigeria – GloxoSmithKline (GSK), NAFDAC and members of NAFDAC’s National Drug Safety Advisory Committee, the Agency has deemed it necessary to take the following preliminary immediate
steps to forestall unwarranted exposure of Nigerians to rosiglitazone-containing medicines:
GSK which is currently the only company marketing rosiglitazone-containing products is to obtain comprehensive information on patients exposed to the products and subsequent use of the products should be on a named-patient basis
-          All patients currently on the product should be immediately evaluated by their physicians and any ADR should be reported to NAFDAC. Where there is no benefit for the patient, a switch to a safer alternative should be made immediately. Patients who do not wish to continue with the treatment should be allowed to opt out without prejudice
-          The company is to submit to NAFDAC a compiled report of patients’ evaluation by physicians 6 months from the date of notification by NAFDAC after which a final pronouncement on continued marketing or otherwise of the products  will be made
-          No new patient should be placed on the products unless the benefits far outweigh the risks compared to safer alternatives as determined by the managing physician
-          The Company(GSK) is to develop and forward to NAFDAC a comprehensive risk management plan for the product as a means of ensuring restricted access to the product
-          The distribution of rosiglitazone-containing drugs should be restricted to specialist hospitals where specialist care including safety monitoring can be provided to diabetic patients
-          GSK is to ensure that PSURs submitted in the future to NAFDAC have local content.
-          The company is to ensure safety surveillance for all its products now available in the Nigerian Pharmaceutical market and those to be registered in future.
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