Egypt, Germany, Hungary and Sweden make decisions on rosiglitazone
This article was originally published in SRA
Regulators in Egypt, Germany, Hungary and Sweden have released statements on discontinuing the use of diabetes drugs containing rosiglitazone.
Their announcements follow the decisions of the European Medicines Agency to suspend marketing authorisation for all such products and of the US Food and Drug Administration to impose severe new restrictions on the use of GlaxoSmithKline's Avandia because of potential cardiovascular risks associated with the drug1. The EMA and FDA decisions were announced on 23 September.
The Egyptian Ministry of Health and Population has decided to cancel the registration of all products containing rosiglitazone and remove the drugs from the market2. As such, it has recommended that physicians consider alternate products for the treatment of type 2 diabetes mellitus. The ministry has also set up a pharmacovigilance hotline that physicians can ring if they have any questions regarding rosiglitazone. There are 14 rosiglitazone-containing products registered in Egypt, three of which are registered by GlaxoSmithKline (Avandia, Avandamet and Avaglim) and 11 of which are generics registered by local Egyptian companies.
The German Federal Institute for Drugs and Medical Devices (BfArM) has halted the distribution of drugs containing rosiglitazone3. The agency has granted a transition period until 31 October 2010 – so as not to change the treatment of diabetes patients too quickly – and the products will no longer be distributed in Germany as of 1 November. BfArM has also ordered the cessation of all clinical studies of rosiglitazone-containing drugs.
In Hungary, the National Institute of Pharmacy, the competent national authority for human medicinal products, has suspended the marketing of rosiglitazone products and pharmacies may no longer sell the drugs. The Hungarian Civil Service Procedures Act does not recognise "suspension of marketing authorisation", only "withdrawal of marketing authorisation" (which has not been advised by the EMA, as of yet) and "suspension of marketing". Thus, legally, the marketing authorisations of rosiglitazone preparations remain valid, but their marketing is suspended. However, the outcome is the same.
The sale of rosiglitazone-containing products in Sweden is to be discontinued in the next few months4. In Sweden around 5,000 patients are treated with Avandia or Avandamet. Patients are advised not to discontinue their treatment by themselves, but to discuss with their physician the choice of another medicine.
A number of other countries have also issued regulatory notices regarding rosiglitazone-containing products following the EMA and FDA decisions5. Use of such medicines has been significantly limited in Singapore and suspended in Norway. In the United Arab Emirates, Avandia has been withdrawn from the market.
References
1. Avandia gets suspended in the EU and severely restricted in the US, RAJ Pharma online, 24 September 2010
2. MOHP press release, 23 September 2010
3. BfArM, 23 September 2010, www.bfarm.de/SharedDocs/1_Downloads/DE/Pharmakovigilanz/stufenplverf/rosiglitazon_bescheid_20100923.pdf?__blob=publicationFile
4. Läkemedelsverket Medical Products Agency, 23 September 2010, www.lakemedelsverket.se/Alla-nyheter/NYHETER-2010/Lakemedel-som-innehaller-rosiglitazon-dras-in-tillfalligt-i-EU-/
5. EU, US rosiglitazone decisions spark action in other countries, RAJ Pharma online, 27 September 2010