Materia Medica Malaysiana

June 22, 2007

Prescribers Of Avandia Advised To Adhere To Restrictions

Filed under: Uncategorized — malaysianmedicine @ 8:42 am

KUALA LUMPUR, June 21 (Bernama) — The Ministry of Health Thursday reminded prescribers of rosiglitazone (marketed as Avandia) to adhere to the restrictions for use in patients with cardiac disease as stated in the product information leaflet.
In a statement issued here today, its director of Pharmaceutical Services Datuk Che Mohd Zin Che Awang advised patients not to stop treatment with rosiglitazone, and to discuss the medication with their doctors.
A recently published article in the New England Journal of Medicine has raised concern over increased risk of myocardial infarction and cardiovascular death in patients with Type Two diabetes treated with Avandia.
However, Che Mohd Zin said the risk degree of Avandia related to ischaemic cardiovascular incidents was not yet positively confirmed because some of the studies in the journal included patients who were not treated for the indication approved in the European Union and Malaysia.
The Drug Control Authority (DCA) would continue to monitor the safety of rosiglitazone and any action taken by other regulatory agencies worldwide on this matter, he said.
The DCA will also review the labelling of Avandia and strengthen the warning section so that the risk of congestive heart failure associated with the use of this drug is prominently displayed.
Recently, the United States Food and Drug Administration (USFDA) has issued letters to the manufacturers of Avandia and other drugs in the same therapeutic class, requesting them to include a boxed warning.
Meanwhile, the USFDA has identified 14 brands of toothpaste from China containing diethylene glycol, which is used in antifreeze and as a solvent.
Che Mohd Zin said toiletries including toothpaste had to be registered with the DCA.
He advised consumers to ensure that the products they buy are safe by looking for the registration number on the packs of the products.

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