Medicines board contacts hospitals across State to advise them of decision that drug is unsafe
Martin Wall
The Irish Medicines Board (IMB) said last night that supplies of the drug, Vioxx, which has been linked to increased risk of heart attack and stroke, will be withdrawn from pharmacies around the country from Monday.
On Thursday, Merck & Co, the manufacturer of Vioxx, which is used to treat pain associated with arthritis, withdrew the drug from circulation worldwide after clinical trials showed the heightened risks.
In a statement last night, the IMB, which oversees drug safety in Ireland, said that it had already quarantined stocks of Vioxx.
The IMB has advised thousands of people in Ireland who have been taking Vioxx to contact their doctor or pharmacist about discontinuing treatment and discussing options for alternative medication.
The agency has also contacted doctors and hospitals across the State advising them that the drug was being recalled.
The drug has been licensed in Ireland since 1999 and the IMB has said that it had received eight reports of "cardiovascular-type adverse effects" associated with it. The agency has stressed that these adverse effects were not deaths.
The decision of Merck to withdraw Vioxx from the market followed a three-year clinical trial in the US which showed that use of the drug beyond 18 months increased the risk of cardiovascular events such as heart attack and stroke by between 300 and 400 per cent.
The trial, involving 2,600 people, was attempting to show whether the drug could reduce the risk of colon cancer.
The trial has now been suspended.
Doctors last night reported that patients had contacted their surgeries following the recall of the drug.
The office of one of the country's leading consultant rheumatologists told The Irish Times last night that up to a dozen patients had been in touch seeking information about Vioxx.
The chairman of the Irish Medical Organisation's GP Committee, Dr Martin Daly, said that some GP practices were contacting patients taking the drug directly and advising them of the withdrawal.
The Irish Patients' Association (IPA) last night also urged all patients taking Vioxx to contact their GP.
IPA spokesman Mr Stephen McMahon told The Irish Times last night that it would be discussing the recall of Vioxx at forthcoming meetings with the IMB and the Department of Health.
Mr McMahon said that hoped that a meeting of European drug regulatory bodies scheduled to be held in the days ahead would allow people to be certain of the safety of the entire COX-2 inhibitors class of drugs to which Vioxx belongs.
Meanwhile, in a statement last night another multinational drug manufacturer, Pfizer, said that three long-term studies involving its COX-2 inhibitor, which is known as Celebrex, had not shown any increased risk of heart attack or stroke in patients with arthritis and pain.
"Each COX-2 inhibitor has a distinct chemical structure and we would not expect them to have the same side-effect profile," Dr Joe Feczko, Pfizer's president of worldwide development said in a statement last night.
He said that the data accumulated over time by the company demonstrated that Celebrex did not increase the risk of serious cardiovascular events in patients with arthritis and pain, even at higher than recommended doses.
Pfizer said that there were three ongoing Celebrex studies, involving more than 6,000 patients, being conducted by the National Cancer Institute and the National Institutes of Health in the US and the company itself.
These were assessing Celebrex as a potential preventive treatment in both Alzheimer's Disease and colorectal cancer.