cerivastatin

Cerivastatin
Systematic (IUPAC) name
(E,3R,5S)-7-[4-(4-fluorophenyl) -5-(methoxymethyl) -2,6-dipropan-2-yl-pyridin-3-yl] - 3,5-dihydroxy-hept-6-enoic acid
Identifiers
CAS number	145599-86-6
ATC code	C10AA06
PubChem	446156
DrugBank	APRD00102
Chemical data
Formula	C26H34FNO5
Mol. mass	459.55 g/mol
Pharmacokinetic data
Bioavailability	?
Metabolism	?
Half life	2-3 hours
Excretion	?
Therapeutic considerations
Pregnancy cat.	?
Legal status
Routes	?

In pharmacology, cerivastatin (Baycol®, Lipobay®) is a synthetic member of the class of statins, used to lower cholesterol and prevent cardiovascular disease. It was withdrawn from the market in 2001 because of the high rate of serious side-effects.

Cerivastatin was marketed by the pharmaceutical company Bayer A.G. in the late 1990s as a new synthetic statin, to compete with Pfizer's highly successful Lipitor®.

During post-marketing surveillance, 52 deaths were reported in patients using cerivastatin, mainly from rhabdomyolysis and its resultant renal failure.^[1] Risks were higher in patients using fibrates (mainly gemfibrozil/Lopid®) and in patients using the high (0.8 mg/day) dose of cerivastatin. Another 385 nonfatal cases of rhabdomyolysis were reported. This put the risk of this (rare) complication at 5-10 times that of the other statins.

In 2001, Bayer announced the voluntary withdrawal of the drug from the market.

Important Note

On August 8, 2001 the U.S. Food and Drug Administration (FDA) announced that Bayer Pharmaceutical Division voluntarily withdrew Baycol from the U.S. market, due to reports of fatal Rhabdomyolysis, a severe adverse reaction from this cholesterol-lowering (lipid-lowering) product.^[2] The FDA agrees with and supports this decision. All patients taking Baycol should contact their healthcare providers to discuss alternative treatments.

References

1. ^ Furberg CD, Pitt B. Withdrawal of cerivastatin from the world market. Curr Control Trials Cardiovasc Med 2001;2:205-207. PMID 11806796.
2. ^ FDA Statement About Baycol: http://www.fda.gov/cder/drug/infopage/baycol

Further reading

• World Health Organization - Alert: Voluntary withdrawal of Cerivastatin – Reports of Rhabdomyolysis.

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