An international pharmaceutical company has voluntarily withdrawn one of its products after it was linked to 31 deaths in the United States. The drug "Baycol", produced by Bayer, was aimed at lowering cholesterol.
The drug is sold as "Lipobay" in Ireland. However, chemists in Dublin say that it is not one of the more popular brands dealing with cholesterol. An information sheet with the product also identifies that anyone with a kidney condition or who drinks heavily should consult their doctor before using it.
A Bayer spokesman confirmed to RTÉ News that the product would be withdrawn immediately from the Irish market. He maintained that the difficulties arose with patients who used the Bayer product "Baycol" along with a Pfizzer product called "Gemfibrozil". The "Lipobay" information sheet warns against using the drug with the "Gemfibrozil".
The US regulatory agency, the Food and Drug Administration, said that "Baycol" was linked to a breakdown of muscle cells and could be fatal when used in combination with "Gemfibrozil". The illness, called rhabdomyolysis, involves injury to the kidneys caused by toxic effects of the contents of muscle cells, which break down and enter the bloodstream.
The symptoms, according to the FDA statement, include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The Agency added that: "Most frequently the involved muscle groups are the calves and lower back; however, some patients report no symptoms of muscle injury".
The statement also said that: "In rare cases the muscle injury is so severe that patients develop renal failure and other organ failure, which can be fatal." Baycol is classed as a "statin" drug, which lowers cholesterol by blocking an enzyme in the body involved in synthesising cholesterol, the FDA said.
Analysts at Dutch bank ABM Amro said that patients harmed by the drug could potentially file lawsuits against the group. This could prompt Bayer to consider merging or selling its pharmaceutical division. Bayer had targeted sales of roughly £877 million in 2001 from the product, but some analysts had expected the drug to eventually attain sales of £2.6 billion.
Bayer pharmaceutical division head David Ebsworth said that that Bayer would re-examine its current pharmaceutical strategy following the Baycol problems.
