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RecallDrugs.com Latest News | Product Info | Patient Info | Links | Latest Lawsuit Info Home | Why Drugs Get Recalled | Buying Drugs Online | Drugs To Watch FDA Talk Paper - August 08, 2001 Baycol - Questions and Answers Bayer Letter to Health Care Professionals - August 08, 2001 Bayer Letter to Health Care Professionals - May 21, 2001 FDA today announced that Bayer Pharmaceutical Division is voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from this cholesterol-lowering (lipid-lowering) product. The FDA agrees with and supports this decision. Baycol (cerivastatin), which was initially approved in the U.S. in 1997, is a member of a class of cholesterol lowering drugs that are commonly referred to as "statins." Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins. Fatal rhabdomyolysis reports with Baycol have been reported most frequently when used at higher doses, when used in elderly patients, and particularly, when used in combination with gemfibrozil (LOPID and generics), another lipid lowering drug. FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with use of Baycol, 12 of which involved concomitant gemfibrozil use. Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The pain may involve specific groups of muscles or may be generalized throughout the body. Most frequently the involved muscle groups are the calves and lower back; however, some patients report no symptoms of muscle injury. In rare cases the muscle injury is so severe that patients develop renal failure and other organ failure, which can be fatal. Bayer Pharmaceutical Division has announced plans to withdraw Baycol to the pharmacy level. Pharmacies will be instructed to return the product to the manufacturer for a refund. Patients who are taking Baycol should consult with their physicians about switching to alternate medications to control their cholesterol levels. Patients taking Baycol who are experiencing muscle pain or are also taking gemfibrozil should discontinue Baycol immediately and consult their physician. There are five other statins available in the U.S. that may be considered as alternatives to Baycol. They are: lovastatin (Mevacor), pravastatin (Pravachol), simvastatin (Zocor), fluvastatin (Lescol), and atorvastatin (Lipitor). For further information regarding the withdrawal of Baycol, patients and physicians can contact Bayer Customer Service 1-800-758-9794 or the FDA's Drug Information Office at 301-827-4573 or 1-888-INFO-FDA, or go to "Baycol Information" on FDA's Website. 1. What should I do if I am taking Baycol? If you are taking Baycol, contact your physician to discuss alternative medications. If you are taking Baycol and experience muscle pain, discontinue Baycol immediately and contact your physician for further advice. 2. What should I do if I am taking Baycol and gemfibrozil (Lopid)? If you are taking Baycol and gemfibrozil (LOPID), discontinue the Baycol immediately and contact your physician for further advice. 3. What is rhabdomyolysis? Rhabdomyolysis is a very rare condition where serious muscle damage results in release of muscle cell contents into the bloodstream. On very rare instances, rhabdomyolysis may result in kidney damage and other organ damage which may be fatal. 4. How do I know if I am having this serious reaction (rhabdomyolysis) to Baycol? Patients who develop rhabdomyolysis often have muscle aches involving their calves, back, or their entire body. The pain may be accompanied by weakness, fever, nausea, vomiting, and passing of dark urine. 5. What should I do if I think I’m having this reaction (rhabdomyolysis) to Baycol? Stop the drug immediately and call your physician. 6. What is Baycol used for? Baycol is a cholesterol-lowering drug belonging to a class of drugs known as “statins”. It is prescribed to reduce your cholesterol and to reduce your risk of heart disease. 7. Will I have any problems if I stop Baycol? If you were prescribed Baycol to lower your cholesterol, these levels may go back to where they were before you received the drug. These changes will not occur immediately but will most likely occur over a couple of days to weeks. If you stop Baycol, be sure to consult your physician to discuss alternative therapies for lowering your cholesterol. 8. Are there any alternatives to Baycol? There are five (5) other drugs in the same class (statins) available in the U.S. market. They are atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor). There are also other drugs approved for lowering cholesterol that are not statin drugs. You should consult you physician to determine which treatment is right for you. 9. Do the other statins have the same safety concerns as Baycol? All statins have been associated with very rare reports of rhabdomyolysis. These rare cases can occur when the drugs are used alone or in combination with another lipid-lowering drug such as gemfibrozil. However, cases of fatal rhabdomyolysis in association with Baycol use have been reported more frequently than other approved statins. Bayer Letter to Health Care Professionals - August 08, 2001 August 8, 2001 RE: Market withdrawal of Baycol® (cerivastatin) Dear Healthcare Professional: I am writing to inform you of very important new safety information about Baycol (cerivastatin) and rhabdomyolysis. Rhabdomyolysis is a serious, potentially fatal, adverse effect of all statin drugs, including Baycol. It can occur with statin monotherapy, though the risk appears to be increased significantly by concomitant use of gemfibrozil (Lopid). Our ongoing scrutiny of post marketing reports of rhabdomyolysis, including fatalities, has revealed an increased reporting rate of rhabdomyolysis with Baycol relative to other statins, especially when gemfibrozil is co-prescribed. These data also suggest an increased reporting rate of rhabdomyolysis at the 0.8 mg dose of Baycol alone. Bayer Corporation has already placed a contraindication in the Baycol product prescribing information sheet against co-prescription with gemfibrozil and issued letters to healthcare professionals warning against co-prescription of these two drugs. Despite these and other actions, Bayer has continued to receive reports of rhabdomyolysis when gemfibrozil is prescribed as a co-medication. Since the co-prescription of Baycol and gemfibrozil has continued despite communications by Bayer against this practice, the company has decided to take the following voluntary action to prevent further cases of rhabdomyolysis: Effective immediately, Bayer has discontinued the marketing and distribution of all dosage strengths of Baycol. Patients who are currently taking Baycol should have their Baycol discontinued and be switched to an alternative therapy. Bayer is taking this action as part of an ongoing commitment to patients and their healthcare providers to ensure patient safety. It is important to you forward any adverse event information associated with the use of Baycol to Bayer Corporation at 1-800-288-8371. You can also report the information directly to the FDA via the MedWatch system at 1-800-FDA-1088, by mail (using a postage paid form), or the Internet at www.fda.gov/medwatch. If you have further questions regarding this action on Baycol, please contact Bayer customer service at 1-800-758-9794. Yours sincerely, E. Paul Mac Carthy, MD Vice President, Head U.S. Medical Science Bayer Letter to Health Care Professionals - May 21, 2001 May 21, 2001 RE: Prescribing Information Changes Regarding Baycol® (cerivastatin sodium tablets) Dear Health Care Professional: This letter provides important information on the prescribing of Baycol® for the treatment of hyperlipidemia. Recently, Bayer Corporation has voluntarily made changes to the prescribing information for Baycol® in order to provide prescribers and patients with more specific guidance on initiating therapy with the product. These changes are: The "Dosage and Administration" section has been revised to highlight that 0.4mg is the starting dose for Baycol®. "The starting-dose of Baycol® is 0.4mg once daily in the evening regardless of previous lipid therapy. Since the maximal effect of cerivastatin sodium is seen within 4 weeks lipid determinations should be performed at this time and the dose adjusted based upon patient response. Only patients requiring further lipid adjustment should be titrated to 0.8mg. The dosage range is 0.2mg to 0.8mg. In patients with significant renal impairment (creatinine clearance £60 mL/min/1.73m2) lower doses are recommended. Cerivastatin sodium may be taken with or without food."Bayer Corporation has made these revisions because we have received reports of muscle weakness and rhabdomyolysis during the post-marketing period. A substantial number of these cases occurred in patients receiving Baycol® in a manner inconsistent with product labeling: e.g. patients were treated with concurrent gemfibrozil therapy and/or received Baycol® 0.8mg as a starting dose. Rhabdomyolysis has been reported with all statins and is reflected in the corresponding prescribing information for all statins. In December 1999, Bayer Corporation changed the Baycol® prescribing information to include a contraindication with gemfibrozil. The combined use of cerivastatin and gemfibrozil is contraindicated due to a risk for rhabdomyolysis and concurrent use should not occur under any circumstances. Patients taking Baycol® or any other statin should be advised to report promptly to their physician unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. We are making the above-mentioned prescribing revisions because appropriate use of Bayer products and patient safety are the primary concerns of Bayer Corporation. When used as directed, Baycol® effectively and safely treats patients with hyperlipidemia. Please refer to the enclosed prescribing information or Bayer Corporation website at http://bayerpharma-na.com for the prescribing information. If you have further questions regarding this change to the prescribing information, please contact Bayer Clinical Communications at 1-800-288-8371. Sincerely, Richard K. Goodstein, MD Vice President, Scientific Relations 
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