Popular diabetes treatment Avandia has been withdrawn from the market with immediate effect due to safety reasons.
The decision to remove this commonly used drug from the shelves was announced by the Department of Health yesterday, following strong evidence that the drug, which contains rosiglitazone, is associated with an increased risk of heart attack and heart failure.
Although European countries like the UK withdrew Avandia last year, South Africa only decided to follow suit on Sunday at a Medicines Control Council meeting.
The Council, which approves and registers all medicines permitted to be used in this country, then issued a directive on Tuesday for all medicines containing rosiglitazone to be taken off the shelves and that no diabetic patient should get an Avandia prescription.
Avandia is used to treat diabetes mellitus type 2 (formerly known as adult-onset diabetes or non-insulin dependent mellitus).
Department spokesperson Fidel Hadebe said: “No new prescriptions of Avandia will be allowed from now on.”
“Patients on rosiglitazone products should consult with their doctors about the management of their diabetes. While this change could happen at the next routine appointment, patients may wish to see their doctor sooner rather than later,” said Hadebe.
About three million South Africans have diabetes and an estimated 80% of them have the type 2 strain. While the majority of these people are not aware that they have diabetes, withdrawing products like Avandia and Actos will affect many and may even lead to some patients abandoning treatment.
Hadebe cautioned against this, saying: “Patients who are concerned about their safety risks should not stop their treatment abruptly but should contact a healthcare practitioner supervising their diabetic treatment.”
The European Medicines Agency took the decision to withdraw Avandia in September last year after it reviewed the findings of a 2007 study, which revealed that it increases the risk of heart failure. More than 78 000 people participated in the study that involved taking this drug, known to enhance insulin sensitivity.
The manufacturer of Avandia GlaxoSmithKline (GSK) was not available for comment but according to its website regarding this issue it says: “GSK has voluntarily ceased promotion of Avandia in all the countries in which it operates and continues to respond to requests for information and support from healthcare professionals and patients.”