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Cerivastatin
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| 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 | |
| ATC code | C10 |
| PubChem | |
| DrugBank | |
| 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 |
Withdrawn from market |
| Routes | ? |
In pharmacology, cerivastatin (Baycol, Lipobay) was 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 It was withdrawn from the market in 2001 because of the high rate of serious side-effects.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 atorvastatin (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. Bayer A.G. added contraindication about the concomitant use of cerivastatin and gemfibrozil to the package 18 months after the drug interaction was found.[2] Frequency of deadly incidents of rhabdomyolysis with cerivastatin was 16 to 80 times higher than with other statins.[3] 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. Cerivastatin also induced myopathy in a dose-dependent manner when administrated as monotherapy, but that was revealed only after producer of cerivastatin was sued and unpublished company documents were opened.[4]
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 the reports of fatal Rhabdomyolysis.
References
- ^ Furberg CD, Pitt B. Withdrawal of cerivastatin from the world market. Curr Control Trials Cardiovasc Med 2001;2:205-207. PMID 11806796.
- ^ Psaty BM, Furberg CD, Ray WA, Weiss NS (2004). "Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis". JAMA 292 (21): 2622–31. doi:. PMID 15572720.
- ^ Zeitlinger M, Müller M (2003). "[Clinico-pharmacologic explanation models of cerivastatin associated rhabdomyolysis]" (in German). Wien Med Wochenschr 153 (11-12): 250–4. PMID 12879633.
- ^ Saito M, Hirata-Koizumi M, Miyake S, Hasegawa R (2005). "[Withdrawal of cerivastatin revealed a flaw of post-marketing surveillance system in the United States]" (in Japanese). Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku (123): 41–5. PMID 16541751.
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Wikipedia content modification information:
- This page was last modified on 12 June 2008, at 00:30.
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