A LEADING anti-diabetes medicine is to be pulled from pharmacy shelves after a European review of the drug concluded that it could pose an increased risk of heart attack and stroke.
The Irish Medicines Board (IMB) move follows a European Medicines Agency (EMA) recommendation that Avandia (also called Avandamet and Avaglim) be withdrawn from usage. The Irish Medicines Board has advised doctors not to issue any new or repeat prescriptions and asked patients to consult with their doctor about a review of treatment.
After analysing safety data, the EMA decided yesterday that “the risks of rosiglitazone-containing medicines outweighed their benefits”.
Avandia is used to control blood sugar levels in type 2 diabetes patients. It is one of a number of treatments used when patients have struggled to get their condition under control through changes to their lifestyles, such as improving their diet and physical activity levels.
The tablets – given in two doses a day – work by helping to lower blood sugar levels by increasing the sensitivity of liver, fat and muscle cells to insulin.
When the drug was first authorised, it was stated that patients with heart failure or a history of heart failure should not be prescribed rosiglitazone and that the medicine was only to be used in patients whose diabetes did not respond satisfactorily to other anti-diabetes medication.
In June 2010, two further articles became available suggesting that rosiglitazone may be linked to an increased risk of heart problems. This triggered a formal EU review to assess the new information.
The drug was the top-selling diabetes pill in the world but use plummeted after a 2007 analysis linked it to heart attack risks.
GlaxoSmithKline (GSK), which produces the drug, said the company continued to believe it was an important treatment.
GSK’s chief medical officer, Dr Ellen Strahlman said the company’s primary concern was type 2 patients.
“We are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients,” she said.
Patients are advised not to abruptly stop their medication but to first consult with their doctor.
IMB director Dr Joan Gilvarry last night said that users should not panic. “Rosiglitazone has been monitored closely and continually evaluated at European level since it was first licensed. The IMB was actively involved in this and all reviews of rosiglitazone through its membership of the European Medicines Agency’s scientific committees,” she said.
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