"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
Baycol Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Baycol (cerivastatin sodium) blocks the production of cholesterol (a type of fat) in the body and is used to reduce the amounts of LDL (bad) cholesterol and total cholesterol in your blood. It also reduces the amounts of triglycerides (another type of fat) and apolipoprotein B (a protein needed to make cholesterol) in your blood and increases the amount of HDL (good) cholesterol in your blood. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include gas, bloating, nausea, stomach upset, heartburn, abdominal pain, constipation, diarrhea, dizziness, headache, or rash.
The starting-dose of Baycol is 0.4 mg once daily in the evening regardless of previous lipid therapy. Baycol may interact with cyclosporine, gemfibrozil, fenofibrate, niacin, erythromycin, clarithromycin, itraconazole, fluconazole, or ketoconazole. Tell your doctor all medications and supplements you use. Baycol causes birth defects if it is taken during pregnancy. Do not take Baycol if you are pregnant or are planning a pregnancy. This drug passes into breast milk and can harm a nursing infant. Do not take Baycol while breastfeeding.
Our Baycol (cerivastatin sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Baycol FDA Prescribing Information: 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
|Adverse Event|| BAYCOL®
(n = 2231)
(n = 702)
The following effects have been reported with drugs in this class; not all effects listed below have necessarily been associated with cerivastatin therapy.
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.
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.
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.
Hemolytic and Lymphatic System: Anemia, leukopenia.
Hypersensitivity Reaction: Allergic reaction, anaphylactoid reaction, angioedema, urticaria.
Respiratory System: Cough increase.
Urogenital System: Acute renal failure secondary to myoglobinuria.
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)) »
Additional Baycol Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.