The company that makes the anti-cholesterol drug withdrawn from the Irish market last week, has said 52 deaths linked to it may have been caused by doctors prescribing the product in conjunction with other medicines.
German pharmaceutical and chemical firm Bayer, which manufactures Baycol - marketed in Ireland as Lipobay - said it was aware of the possibility of a reaction to the drug among some patients but says there were specific warnings against using the treatment with other products, particularly other anti-cholesterol drugs.
The company said that despite an absence of conclusive proof the drug caused the deaths and that warnings accompanied the product, it has been withdrawn because some doctors were ignoring the company’s advice.
"Since, in spite of all our warnings, we could not be certain that the product would not be prescribed contrary to our recommendations, thus having potentially serious repercussions, we decided to stop marketing the product in the interest of the safety and health of the patients using it," said Dr David Ebsworth, head of Bayer's Pharmaceuticals Business Group.
Most of the deaths have been in the US, but there have also been claims relating to five deaths in Germany, three in Spain and one in France.
The Irish Medicines Board Last week advised patients using Lipobay to contact their doctors. It stressed however, that there had not been reports in Ireland of adverse effects from using the drug.
Further controversy was generated late last week when it emerged the markets were told of the decision to withdraw the treatment before doctors were informed.
In a statement today Bayer chairman Dr Manfred Schneider said regulations demanded any announcement with the potential to significantly affect the share price must first be made available to all investors.
"We were not allowed to notify specific groups of people – such as physicians or pharmacists – in advance, as that would have made them 'insiders'," Dr Schneider said.
"We extend our sincere sympathy to the relatives and friends of any person whose death may have been connected with the use of our product. I must again stress, however, that there is currently no proof that this has been the case," Dr Schneider said.