Bayer decides to withdraw cholesterol lowering drug

The side effects from the cholesterol lowering drugs may offset their benefit.

19 August 2001

To withdraw cerivastatin (Lipobay®, Baycol®) because of 31 fatal side effects in the US is a wise decision, but why has the Federal Drug Administration and Bayer Corporation not reacted before? Did they consider 30 deaths as a rare, but acceptable side effect? The benefit from statin treatment is rare also, in particular when “treating” healthy people. In the WOSCOP trial, for instance, the odds of escaping a fatal heart attack in five years for healthy people with high cholesterol was 98.4 %, which improved non-significantly to 98.8 % after pravastatin treatment.1 As the effect of the statins on mortality is trivial, fatal side effects may easily counteract their benefit. Bear in mind that the reported number of side effects is the top of the iceberg; few doctors report side effects of their treatment, or they may view them as natural manifestations of old age.

It is therefore praiseworthy that the European Agency for the Evaluation of Medicinal Products has announced a review of all cholesterol lowering drugs. For instance, the agency should ask for the final result of the first statin trial, EXCEL, where total mortality probably was significantly higher in the lovastatin group (0.5% versus 0.2%; no other figures were given) already after one year.2 They should also ask why recurrence of breast cancer, the only side effect noted significantly more often in the pravastatin trial CARE,3 is not mentioned on the drug label.

Such unfortunate results are particularly worrying considering that the new guidelines for treating high cholesterol, recently published by the US National Cholesterol Education Program, recommend treatment with cholesterol lowering drugs for a considerable part of mankind.4

Uffe Ravnskov

1. Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, McKillop JH, Packard CJ. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med 1995;333:1301-7.

2. Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA, Langendorfer A, Stein EA, Kruyer W, Gotto AM. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA 1998;279:1615-22.

3. Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, Brown L, Warnica JW, Arnold JM, Wun CC, Davis BR, Braunwald E. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med 1996;335:1001-9.

4. Ravnskov U. New cholesterol guidelines for converting healthy people into patients. 2001; http://www.ravnskov.nu/ncep_guidelines.htm

Competing interests: None declared

Uffe Ravnskov

Magle Stora Kyrkogata 9, S-22350, Lund, Sweden

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