FDA NEWS: "Cholesterol-Lowering Drug Baycol Being Withdrawn"
fda.gov
"BAYER VOLUNTARILY WITHDRAWS BAYCOL"
fda.gov
"Cholesterol Drug Taken Off Market--Numerous Deaths Linked to Baycol"
washingtonpost.com
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August 8, 2001 Broadcast Media: 301-827-3434
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BAYER VOLUNTARILY WITHDRAWS BAYCOL
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 recall 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.<<<
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Cholesterol Drug Taken Off Market
Numerous Deaths Linked to Baycol
By David Brown
Washington Post Staff Writer
Thursday, August 9, 2001; Page A01
The maker of cerivastatin, a popular cholesterol-lowering drug used by about 700,000 Americans, voluntarily pulled the medicine off the market yesterday because of numerous deaths associated with its use.
Officials at the Food and Drug Administration said 31 people have died of complications of severe muscle breakdown, a rare but well-recognized side effect of many cholesterol-lowering drugs. In about one-third of the cases, the person was on a second cholesterol drug, gemfibrozil, known to especially increase the risk of problems.
Cerivastatin is one of six "statins," a popular family of drugs prescribed to about 12 million Americans to treat, and possibly prevent, coronary heart disease. Reports of severe side effects, including death, are at least 10 times more common for cerivastatin than for other drugs in the class.
"We are not considering any regulatory action with regard to the other approved statins," said John Jenkins, director of the FDA's office of drug evaluation. The other statins are lovastatin (Mevacor), pravastatin (Pravachol), simvastatin (Zocor), fluvastatin (Lescol) and atorvastatin (Lipitor).
Bayer AG, the German company that makes cerivastatin, introduced the drug under the trade name Baycol in January 1998. The first death was reported in January 2000, with the number of complications rising markedly when a high-dose pill was introduced last August.
Before and after the first death, Bayer officials warned doctors against prescribing cerivastatin with gemfibrozil and strongly advised that patients be started on a low dose. That advice, and changes in cerivastatin's official labeling, appeared to change prescribing behavior to some extent, but not enough to eliminate the problem.
"We had options of keeping the lower doses on the market, but we took this decision in the interest of patient safety," said Paul MacCarthy, vice president of medical science for Bayer's U.S. operations.
Drug recalls are rare. From 1981 to 2000, the FDA approved 543 new drugs for use. Fourteen, or 2.6 percent, were subsequently recalled -- either voluntarily, or by FDA action -- for safety reasons.
Cerivastatin is fifth out of the six statins in number of prescriptions written, according to data provided by IMS Health, a pharmaceutical monitoring company in Pennsylvania. But the drug's market share was growing. It was 6.7 percent at the end of June, up from 2.5 percent at the end of 2000.
The drug is the third biggest selling prescription drug in Bayer's portfolio. Worldwide, it accounted for $560 million in sales last year, and was expected to grow to about $880 million this year, said Gunter Forneck, spokesman at the company's German headquarters.
Cerivastatin, which is used worldwide by about 6 million people, is also being taken off the market in Europe. It will remain available only in Japan, where gemfibrozil is unavailable.
Physicians have known since the first statin was introduced in 1987 that a few patients develop muscle inflammation, experienced as soreness or tenderness, while taking the drug. Occasionally, that progresses to whole-scale muscle breakdown, a condition called rhabdomyolysis. That, in turn, can lead to kidney failure, as the bloodstream is flooded with relatively toxic proteins released by the dissolving tissue. Jenkins said 29 of the 31 people who died had kidney failure.
People at increased risk for the complication are those taking both cerivastatin and gemfibrozil (sold under the trade name Lopid), and those taking the 0.8 milligram cerivastatin dose. The FDA advised people in those groups to stop taking cerivastatin and consult their doctors about alternative medicines.
Some deaths have also occurred with use of the 0.4 milligram pill, and when the drug is taken alone. The elderly, and possibly women, also appear to be at higher than usual risk for the complication.
Combination use of statins and fibrates -- the family to which gemfibrozil belongs -- isn't necessarily a mistake. The two types of drugs alter blood fats in different ways, and are sometimes intentionally prescribed to patients with severe cholesterol problems despite the rare risk of rhabdomyolysis, which generally reverses itself if the drugs are stopped immediately.
Because of the signs that the cerivastatin-gemfibrozil interaction was more common, Bayer put in the drug's labeling a specific prohibition against using them together. When the deaths began appearing, the company sent a letter to all doctors and prohibited its salesmen from giving away samples of the 0.8 milligram dose, said Tig Conger, Bayer's vice president for cardiovascular marketing.
The company recently presented the FDA data from a managed-care plan showing the education campaign had reduced "concomitant dispensing" of the drugs a little. Eliminating it altogether is nearly impossible, Jenkins said.
"There are just too many factors -- patients seeing multiple physicians or going to multiple pharmacies; patients forgetting to tell their doctors what medicines they're on or using leftover medication," he said.
The difficulty is clear from a case seen last year by Roberto Lufschanowski, a cardiologist at the Texas Heart Institute in Houston. A man in his seventies appeared with rhabdomyolysis so severe he was too weak to lift his head off the bed. He had been prescribed gemfibrozil and another statin but had recently switched to cerivastatin when a non-physician friend gave him some samples. He survived.
Lufschanowski, who reported the case in a medical journal, said he expects cerivastatin's withdrawal will have no effect on statin use overall.
"The beneficial effects of statins are so overwhelming. They are a part of our routine care of patients with coronary artery disease," he said.
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