SIDE EFFECTS

Cerivastatin sodium has been evaluated for adverse events in more than 5,000 patients worldwide. In the U.S. placebo-controlled clinical studies, discontinuations due to adverse events occurred in 3.1% of cerivastatin sodium treated patients and in 2.0% of patients treated with placebo. Adverse reactions have usually been mild and transient.

Clinical Adverse Experiences

Adverse experiences occurring with a frequency ≥ 2% for marketed doses of cerivastatin sodium, regardless of causality assessment, in U.S. placebo-controlled clinical studies, are shown in Table 5 below:

Table 5: Adverse Experiences occurring in ≥ 2% Patients in U.S. Placebo Controlled Clinical Studies

The following effects have been reported with drugs in this class; not all effects listed below have necessarily been associated with cerivastatin therapy.

Skeletal: myopathy, muscle cramps, rhabdomyolysis, arthralgias, myalgia.

Neurological: dysfunction of certain cranial nerves (including alteration of taste, impairment of extra-ocular movement, facial paresis), tremor, dizziness, memory loss, vertigo, paresthesia, peripheral neuropathy, peripheral nerve palsy, anxiety, insomnia, depression, psychic disturbances.

Hypersensitivity Reactions: An apparent hypersensitivity syndrome has been reported that included one or more of the following features: anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.

Gastrointestinal: pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, and hepatoma; anorexia, vomiting.

Skin: alopecia, pruritus. A variety of skin changes, (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails), have been reported. Reproductive: gynecomastia, loss of libido, erectile dysfunction.

Eye: progression of cataracts (lens opacities), ophthalmoplegia.

Laboratory Abnormalities: elevated transaminases, creatine kinase, alkaline phosphatase, γ-glutamyl transpeptidase, and bilirubin; thyroid function abnormalities.

Post-Marketing Adverse Event Reports

The following events have been reported since market introduction. While these events were generally associated with the use of BAYCOL® (cerivastatin (removed from market 8/2001)) , a casual relationship to the use of BAYCOL® (cerivastatin (removed from market 8/2001)) cannot be readily determined due to the spontaneous nature of reporting of medical events, and the lack of controls.

Body as a Whole: Asthenia, fever, headache, anorexia, abdominal pain, epistaxis, edema.

Cardiovascular System: Hypertension, angina pectoris.

Digestive System: Colitis, constipation, diarrhea, duodenal ulcer, dyspepsia, flatulance, gastrointestinal disorder, gastrointestinal hemorrhage, hepatitis, nausea.

Hemolytic and Lymphatic System: Anemia, leukopenia.

Hypersensitivity Reaction: Allergic reaction, anaphylactoid reaction, angioedema, urticaria.

Nervous System: Paralysis, somnolence.

Musculoskeletal System: Myalgia, myasthenia, myopathy, myositis, rhabdomyolysis, hypertonia, hyperkinesia.

Respiratory System: Cough increase.

Urogenital System: Acute renal failure secondary to myoglobinuria.

Special Senses: Cataract specified, visual disturbance, blurred vision.

Laboratory Abnormalities

Amylase increase, elevated transaminases, laboratory tests abnormal, kidney function abnormal, creatine phosphokinase increase.

Concomitant Therapy

In studies where cerivastatin sodium has been administered concomitantly with cholestyramine, no adverse reactions unique to this combination or in addition to those previously reported for this class of drugs were reported. Myopathy and rhabdomyolysis (with or without acute renal failure) have been reported when HMG-CoA reductase inhibitors are used in combination with immunosuppressive drugs, fibric acid derivatives, erythromycin, azole antifungals or lipid-lowering doses of nicotinic acid. Concomitant therapy with HMG-CoA reductase inhibitors and these agents is generally not recommended (see WARNINGS: Skeletal Muscle). Concurrent treatment with gemfibrozil is contraindicated (see CONTRAINDICATIONS and WARNINGS: Skeletal Muscle).

Read the entire FDA prescribing information for Baycol (Cerivastatin (Removed from Market 8/2001)) »