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Bayer decides to withdraw cholesterol lowering drug

BMJ 2001; 323 doi: http://dx.doi.org/10.1136/bmj.323.7309.359/a (Published 18 August 2001) Cite this as: BMJ 2001;323:359

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

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: No competing interests

19 August 2001
Uffe Ravnskov
Magle Stora Kyrkogata 9, S-22350, Lund, Sweden
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