Criticism of the way long-established drugs are being withdrawn from the Irish market has been rejected by the Irish Medicines Board (IMB), which processes drug authorisations. Doctors have claimed that the withdrawal of drugs with a proven record of effective treatment is causing difficulties for patients and for the medical profession. The recent withdrawals had followed a routine request by the IMB to renew product registration. One doctor who spoke to The Irish Times said the recent indication by a drugs company that it was to withdraw three products was "very upsetting" for many of his patients. "They are familiar with these drugs. It is intensely annoying when they are withdrawn like this."
The Dublin doctor claimed that requests by the IMB to extend research on the drugs to evaluate their effects had been rejected by drug companies on cost grounds. As they were on the market for a long time and were relatively cheap, the drugs companies prefer to simply withdraw the product. This interpretation was rejected by the company responsible for the most recent withdrawals. Schering confirmed it recently withdrew three well-known drugs and had written to alert the country's 2,200 doctors. The withdrawal was because the products had come to the end of their commercial life. Some had come on the market during the 1950s, according to the company.
The drugs involved are: Microlut, a progesterone-only contraceptive pill used by older women; a hormonal control drug called Cycloprogynova; and Testovirondepo, a drug on the market for more than 40 years which is used in impotence treatment, though not promoted by the company for such a purpose.
The general manager of Schering (Ireland), Mr Conn Clissman, said the products had outlived their usefulness and suitable alternatives were on the market.
The recent withdrawals had followed a routine request by the IMB to renew product registration - as applies to all drugs every five years - and to have up-to-date information on the drug. As products became older, however, there was little opportunity to do clinical studies of their performance.
"We gave advance warning to doctors. We are very conscious of trying not to upset patients and doctors," Mr Clissman said. The withdrawals had also to be put in the context of Schering having 108 formulations on the Irish market at present, Mr Clissman said. Schering had received only one complaint from a doctor following the recent withdrawals.
Dr John G. Kelly, chief executive of the Irish Medicines Board, said the Schering drugs in question still had active product authorisations. "The IMB has not requested or required them to be withdrawn."
The doctors' criticism was not justified, he said. They were incorrect in their supposition about the manner of their withdrawal. "We believe the company has simply decided not to market them."
