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THE BAYCOL ® RECALL On August 8, 2001, the United States Food and Drug Administration (FDA) announced that Bayer Pharmaceutical Division voluntarily withdrew Baycol ®, which has been taken by approximately 700,000 Americans, from all markets (now including Japan). The FDA reports that over 480 cases of the potentially deadly condition rhabdomyolysis, including over 52 deaths, have been associated with patients who used Baycol ® (Lipobay ® outside the United States). Baycol ® is a medication commonly prescribed to lower patients cholesterol and triglycerides levels. Baycol ® lowers cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. WHAT IS "BAYCOL" ®? Baycol ® (Cerivastatin) is a prescription drug designed to lower cholesterol and reduce the risk of heart attack. Baycol ®, approved by the FDA in 1997, is a member of a class of cholesterol lowering drugs referred to as "statins." Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. According to the FDA, while all statins have been associated with reports of rhabdomyolysis, the number of reported cases of fatal rhabdomyolysis is significantly higher for patients who use Baycol ® than it is for patients taking other FDA approved statins. A majority of the reported fatal cases involve a high dosage of Baycol in elderly patients, particularly when Baycol ® is used in combination with a lipid lowering drug called gemfibrozil (Lopid ® and its generic). WHAT IS RHABDOMYOLYSIS? 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 muscles affected are the calves and lower back. However, some patients report no symptoms of muscle pain. In rare cases the muscle injury is so severe that patients develop renal (kidney) failure and other organ failure, which can be fatal. Rhabdomyolysis may also include damage to the kidneys caused by toxic effects from the contents of the muscle cells. Myoglobin is an iron-containing pigment found in the skeletal muscle. When the skeletal muscle is damaged, the myoglobin is released into the bloodstream. It is filtered out of the bloodstream by the kidneys. Myoglobin may occlude the structures of the kidney, causing damage such as acute tubular necrosis or kidney failure. Myoglobin breaks down into potentially toxic compounds, which also causes kidney failure. Also, necrotic skeletal muscle (dead tissue) may cause massive fluid shifts from the bloodstream into the muscle, reducing the relative fluid volume of the body and leading to shock and reduced blood flow to the kidneys. If you have taken Baycol ® and have experienced any of the following problems, you should contact your doctor immediately. SYMPTOMS OF RHABDOMYOLYSIS Abnormal urine color (dark, red, or cola colored) Muscle tenderness weakness of the affected muscle(s) Generalized weakness Muscle stiffness or aching (myalgia) Seizures Pain in the joints Unintentional weight gain Body fatigue Body weakness Muscle necrosis Weakness of the muscles Chills Shakes Trauma from fluid loss Heatstroke BAYCOL ® COMPLICATIONS Rhabdomyolysis Crush Syndrome Kidney Failure Liver Failure Organ Failure Acute Renal Failure Acute Tubular Necrosis KIDNEY FAILURE Rhabdomyolysis breaks down the muscle cells and releases the contents of the muscle cells into the blood stream. These cells contain myoglobin, an iron containing pigment. The kidneys try to remove this toxic substance from the blood stream. Kidney failure can result when the myoglobin blocks or occludes the kidneys creating a toxic reaction (Crush Syndrome). OTHER SIDE EFFECTS Baycol ® has also been linked to several other serious side effects, including: Peripheral neuropathy: A condition that involves loss of sensation in the hands and feet. Gastrointestinal side effects: Common and they can be so severe that 5 to10% of patients have stopped taking Baycol ®. Allergic or Hypersensitivity reactions: Common and create "lupus-like" symptoms in patients using Baycol ® for over six months. Liver enzymes: Baycol ® has been linked to a rise in liver enzymes which can cause hepatitis like conditions. HIGH RISK GROUPS There are three high-risk groups of Baycol ® consumers: Elderly patients High dosage Baycol ® patients (.8 milligram dose) Patients taking Baycol ® and gemfibrozil (Lopid ® and its generic) The greatest risk of developing rhabdomyolysis exists with Baycol ® users who take it in combination with Lopid ® (the trade name for gemfibrozil, a fibrate). The two drugs alter blood fats in different ways. WHAT IF I AM TAKING BAYCOL ®? You should consult with your physician as soon as possible. If you are taking Baycol ® and gemfibrozil (Lopid ®), discontinue the Baycol ® immediately (according to the FDA www.fda.gov/cder/drug/infopage/baycol/default.htm ) and contact your physician for further advice. Other cholesterol-lowering statins on the market include Lipitor ®, Lescol ®, Zocor ®, Pravachol ®, and Mevacor ®. Baycol ® has been found to be up to ten times more likely to have adverse side effects than the other five statins. REPORTS FROM AROUND THE US "Basically, my body was attacking my muscle cells, opening them and stripping out the protein. It was like that old Pac Man game, gobbling everything in sight. I don't think Baycol should have been on the market, I don't think it was properly researched." David Miller, Rochester Hills, MI The Detroit News, Aug. 24, 2001 The drop in her white blood cell count after ingesting Baycol was "scariest thing that has happened in my life. It really frightened me because I didn't know what it was and the doctors didn't know either. I know I'm a bit of an old lady, but I wanted to live to be a real old lady." Dolores Canter, Seffner, FL, The St. Petersburg Times, Aug. 23, 2001 Xyuen Tran began taking Baycol in the spring of last year. She began to feel weak and feverish and was hospitalized with kidney failure, joint pain, muscle degeneration and chronic fatigue. My mother's condition "was so terrible that everybody thought she wouldn't make it. She couldn't stand up at all." Phil Vo, Orlando, FL, The Orlando Sentinel, Aug. 22, 2001 WHAT SHOULD YOU DO? If you have been prescribed and taken the potentially deadly anti-cholesterol drug Cerivastatin, also known as Baycol ® (Lipobay ® outside the United States) and have experienced or are experiencing injuries from Baycol ®: First, follow the advice of your doctor regarding your injuries. Second, Contact us http://daviddanda.lawoffice.com/guest.htm regarding a review of your claim and possible compensation for your injuries. PRESERVING YOUR CLAIM All states have filing deadlines. If you have, or a family member has, taken Baycol® and want to consult with a lawyer and preserve your claim, please Click Here and complete the Questionnaire, or call 770.938.0977. David Danda is an attorney, comedian and national marketing coach and columnist who helps businesses market more effectively by leveraging technology. He can be reached at 770.938.0977, or through his website at www.daviddanda.com. You may reproduce and distribute this copyrighted© material provided the author is appropriately identified. Author PERSONAL INJURY FAQ | CONTACT US | RESOURCES | ARTICLES Any information you may obtain from this site is not, nor is it intended to be legal advice. You should consult an attorney for individual, specific advice regarding your own situation. You may reproduce any of the materials available on this site for your own personal use and for non-commercial distribution. All copies must include the following copyright notice. COPYRIGHT 2005 © David E. Danda, P.C. • Atlanta, GA 31141 |
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