Microsoft word - dear healthcare provider letter on rosiglitazone.docx

This letter is intended to alert health care providers particularly physicians on the elevated risk of cardiovascular events such as myocardial infarction, heart attack and stroke in patients treated with rosiglitazone-containing medicines for type 2 diabetes. Due to cardiovascular concerns, the EMA has suspended the marketing authorizations for rosiglitazone- containing medicines (Avandia, Avandamet and Avaglim) while the USFDA has significantly restricted the use of rosiglitazone to Type 2 diabetic patients who cannot control their diabetes on other medications. These actions follow recent reviews of outcomes of new studies which question the cardiovascular safety of rosiglitazone which has always been kept under close review since it was first granted marketing authorization. The medicine has been associated with fluid retention and increased risk of 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. A search of the WHO global database on ADRs which contains about 5 million reports revealed several cases of ADRs due to the use of rosiglitazone. The reported reactions are myocardial infarction with a frequency of 3828, weight gain (1855), peripheral oedema (1472), death (1203) and dyspnoea (1176). On the other hand, only one ADR report involving bilateral leg swelling and peri-orbital swelling has been reported to the NPC since the product was granted marketing authorization in Nigeria in 2002. This may not reflect the true picture of the morbidity from the use of roseglitazone-containing medicines considering the very low reporting rate of ADRs in Nigeria and other peculiarities of our healthcare Consequently, NAFDAC in collaboration with its National Dug Safety Advisory Committee and after interaction with the MAH has reviewed the facts/data available to it and has put the following interim - 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 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 is to be restricted to specialist hospitals where specialist care including safety monitoring can be provided to diabetic patients Please revert to the undersigned for necessary clarification.

Source: http://www.nafdac.gov.ng/images/PUBLICATIONS/Dear%20healthcare%20provider%20letter%20on%20rosiglitazone.pdf