Drug maker pulls cholesterol-lowering Baycol after reports of 40 deaths
August 8, 2001: 6:09 p.m. ET
NEW YORK (CNNfn) – Bayer pulled a cholesterol-lowering medicine taken by 700,000 Americans from shelves Wednesday after it was associated with 31 deaths in the United States and at least nine deaths in other countries.
Bayer said it recalled Baycol after it received reports that the drug caused deterioration in muscle tissue, a condition called rhabdomyolysis, which is known to cause severe pain and potential kidney failure.
Baycol is in a family of drugs called statins, which blocks an enzyme that creates cholesterol. Other drugs in the family, Mevacor, Pravachol, Zocor, Lescol, and Lipitor, remain on the market.
Out of the 31 deaths in the United States, 12 occurred when patients used Baycol in combination with gemfibrozil, another cholesterol-lowering drug. Baycol remains on shelves in Japan, where dosages are lower and gemfibrozil is not available.
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"We have decided on this action in the interest of patient safety," David Ebsworth, manager of Bayer Pharmaceuticals Business Group, said in a statement. "We continue to conduct further assessments over the next few months to evaluate the benefit/risk ratio of [Baycol]."
In addition, Bayer said earnings for the full year will fall "substantially short" of previous estimates and its target of a 20 percent return on sales can no longer be met.
The drug was expected to generate sales of 1 billion this year, Bayer said, up from 636 million last year. Chief Financial Officer Werner Wenning said on a conference call earnings would fall between 600 million and 650 million this year, and 250-300 million would be booked as an exceptional charge
"Baycol was Bayer's only real growth product…leaving the company with no visible sales growth over the next five years," analysts at J.P. Morgan wrote in a note to investors.
Bayer, which makes products ranging from Aspirin to chemicals for industry and fragrances for perfumes, also issued a profit warning in June, citing a slowdown in world economic growth.
The German company said then it expected second-quarter and full-year profits to decline, with 2001 operating profit before one-time items dropping to about 3 billion ($2.6 billion) from 3.3 billion last year.
The German company's shares plunged as much as 15.6 percent to a 20-month low of 38.29 after the announcement. The stock has fallen more than 28 percent from a year high of 58.00 on January 2.