Cerivastatin (Baycol): Withdrawn Statin Due to Fatal Rhabdomyolysis

Cerivastatin (brand Baycol, Lipobay) — synthetic HMG-CoA reductase inhibitor (statin) withdrawn globally (2001) except China.

Withdrawal Cause

• Disproportionately high rate of rhabdomyolysis (muscle breakdown → myoglobinuria → acute kidney injury)
• ≥52 deaths attributed; risk amplified with gemfibrozil combination, renal impairment, elderly, high dose (0.8 mg)
• FDA requested voluntary withdrawal; Bayer complied.

Context

• Approved 1997; 0.2–0.3 mg doses initially.
• Other statins (atorvastatin, simvastatin, rosuvastatin) have better safety profiles.
• Case study in post-marketing surveillance, drug-drug interactions (CYP2C8/CYP3A4), and risk-benefit monitoring.