Note: This document contains side effect information about cerivastatin. Some dosage forms listed on this page may not apply to the brand name Baycol.

Applies to cerivastatin: oral tablet.

General

Evaluations of adverse events in more than 3,000 patients during clinical trials have shown cerivastatin (the active ingredient contained in Baycol) to be well tolerated. Adverse effects that occurred were generally mild and transient and the percentage of patients discontinuing cerivastatin was similar to that of the placebo groups in U.S. placebo-controlled clinical trials.^[Ref]

Hepatic

Hepatic adverse effects of cerivastatin (the active ingredient contained in Baycol) consist primarily of elevations in liver function tests, however, hepatitis has been reported. Hepatic side effects reported with other HMG-CoA reductase inhibitors are hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in the liver, cirrhosis, fulminant hepatic necrosis and hepatoma.^[Ref]

According to the manufacturer, persistent elevations of serum transaminases to more than 3 times the upper limit of normal have been reported in less than 1% of U.S. patients given cerivastatin for an average duration of 11 months. Liver function test abnormalities generally occurred within the first 6 weeks of treatment, were asymptomatic, and resolved after withdrawal of the medication.^[Ref]

Gastrointestinal

Gastrointestinal adverse effects include dyspepsia (less than 6%), diarrhea, abdominal pain, or flatulence (less than 4%), nausea (less than 3%), and constipation (less than 2%). Other gastrointestinal side effects of HMG-CoA reductase inhibitors include pancreatitis, anorexia, and vomiting.^[Ref]

Musculoskeletal

HMG-CoA reductase inhibitors (statins) have been associated with rare cases of severe myopathy and rhabdomyolysis, accompanied by increases in creatine kinase, myoglobinuria, proteinuria, and renal failure. Concomitant use with gemfibrozil (fibric acid derivatives), niacin, cyclosporine, erythromycin (macrolides) or azole antifungals may increase the incidence and severity of musculoskeletal side effects. Other variables associated with an increased risk of statin-induced myopathy include, advanced age, small body stature, female gender, renal and/or hepatic dysfunction, perioperative periods, hypothyroidism, diabetes mellitus, and alcoholism.

Milder forms of myotoxicity (i.e., myalgia) are commonly reported and occur in approximately 5% to 7% of patients taking a statin drug.

Patients should be instructed to promptly report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured and if markedly elevated, cerivastatin (the active ingredient contained in Baycol) should be discontinued. The value of routine monitoring of creatine kinase is not known.^[Ref]

Musculoskeletal adverse effects include arthralgia (less than 7%) and myalgia (less than 3%). Myopathy manifesting as muscle aches or muscle weakness with increases in plasma creatine kinase values to greater than 10 times the upper limit of normal occurred in less than 0.2% of patients in U.S. clinical trials. Cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been associated with cerivastatin and other HMG-CoA reductase inhibitors.

In addition, some data have suggested that exposure to HMG-CoA reductase inhibitors is associated with a decreased risk of bone fractures in persons older than 50 years of age.^[Ref]

Hematologic

Hematologic side effects including hemolytic anemia, thrombocytopenia, and leukopenia have occurred with HMG-CoA reductase inhibitors. These effects may be manifestations of a hypersensitivity reaction.^[Ref]

Nervous system

Nervous system adverse effects are primarily headaches (less than 12%), dizziness (less than 3%) and insomnia (less than 3%). HMG-CoA reductase inhibitors as a class have been associated with cranial nerve dysfunction, tremor, vertigo, memory loss, anxiety, paresthesias, peripheral neuropathy, and peripheral nerve palsy.^[Ref]

Cardiovascular

Cardiovascular adverse effects of peripheral edema have been reported in 2% of patients in U.S. clinical trials.^[Ref]

Dermatologic

Dermatologic adverse effects of rash have been reported in less than 3% of patients in U.S. clinical trials. Other dermatologic side effects reported with HMG-CoA reductase inhibitors include pruritus and alopecia.^[Ref]

Endocrine

Endocrine adverse effects of HMG-CoA reductase inhibitors include gynecomastia and thyroid dysfunction.^[Ref]

Hypersensitivity

Hypersensitivity syndrome has been reported rarely with HMG-CoA reductase inhibitors. Manifestations include anaphylaxis, angioedema, purpura, urticaria, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis, photosensitivity, fever (including severe hyperthermia), chills, flushing, malaise and dyspnea. Urticaria and angioedema have occurred during cerivastatin (the active ingredient contained in Baycol) therapy.^[Ref]

Immunologic

Immunologic adverse effects of HMG-CoA reductase inhibitors include a lupus-like syndrome with positive ANA and elevated ESR, polymyalgia rheumatica, dermatomyositis and vasculitis. These effects may be manifestations of a hypersensitivity reaction.^[Ref]

Ocular

Ocular adverse effects occurring during cerivastatin (the active ingredient contained in Baycol) therapy include visual disturbances and blurred vision. Progression of cataracts and ophthalmoplegia has been associated with the use of other HMG-CoA reductase inhibitors.^[Ref]

Psychiatric

Psychiatric adverse effects of HMG-CoA reductase inhibitors include loss of libido and depression.^[Ref]

Genitourinary

Genitourinary adverse effects of erectile dysfunction have been reported with other HMG-CoA reductase inhibitors.^[Ref]

Halkin, et al report a case in which use of both lovastatin and pravastatin (different occasions in the same patient) led to reversible impotence. The impotence resolved within 2 weeks following discontinuation of the HMG-CoA reductase inhibitor.^[Ref]

Oncologic

Oncologic side effects including tumor growth in rodents has been associated with many lipid-lowering drugs. Cerivastatin (the active ingredient contained in Baycol) has been specifically associated with hepatocellular carcinomas and adenomas. Long-term clinical trials are needed to define the risk of cancer in humans.^[Ref]