No reports of heart disease linked to use of the anti-obesity drug, Adifax, have been notified in the State, according to the Irish Medicines Board. However, people receiving treatment or who have taken the drug in the past have been advised to contact their doctors. The withdrawal of Adifax (dex fenfluramine), which works by suppressing the appetite, and another anti-obesity drug, Ponderax (fenfluramine), because of "new evidence about significant side-effects", was requested by the US Food and Drug administration. The drugs, which were developed by the French company, Servier, are also to be withdrawn from all other markets worldwide.
The Irish Medicines Board said it was liaising with the pharmaceutical manufacturer on the withdrawal of the products and notification of healthcare professionals. "To date, no reports of valvular heart disease from the use of fen fluramine or dexfenfluramine either alone or in combination with any other anorectic agents have been notified in Ireland," the board said.
Research at the Mayo Clinic, published in the New England Journal of Medicine last month, showed a higher-than-expected percentage of abnormal heart valve readings among patients taking the drugs. Before Monday's action, the FDA had already warned of potential dangers and requested additional labelling.
Servier Laboratories (Ireland) Ltd said yesterday that as a precautionary measure, it would withdraw the drugs voluntarily. Wyeth Ayerst and Interneuron, which market the drugs in the US, have made a similar announcement. They have also launched research programmes "to establish the facts".
In a statement yesterday, Servier said reports citing cardiac valve anomalies l did not permit any conclusion to be made, in particular with reference to a causative link between the drugs and the development of valvular lesions.
"Since these drugs were first made available - 35 years ago for fenfluramine and 12 years ago for dexfenfluramine - more than 60 million patients have been treated with fenfluramine and more than 10 million with dexfen fluramine, without any report of valvulopathy being directly attributed to them," according to the statement. Servier managing director, Dr Jean Holohan, was returning from abroad yesterday and there was no one available for further comment.
The IMB statement said patients who were receiving treatment or who had received treatment with the drugs in the past were advised to contact their doctors. A Dublin GP, Dr Edmond O'Flaherty, said the drugs were generally prescribed by GPs for very obese people and were usually requested by women.
Dr O'Flaherty said the Mayo Clinic had only found 24 people with valvular heart disease as a result of using the drugs. "The FDA tested this drug very thoroughly. It is not a common problem. However, it does happen and can be serious," he said.