Manufacturer: Bayer Pharmaceutical Division
Date approved: 1997
Status: Voluntarily withdrawn by manufacturer
Approved uses: Baycol is used to lower cholesterol (lipids)
Off-Label uses: N/A
• Fatal Rhabdomyolysis
• Skeletal Damage
• Kidney Damage
Related topics: Cholesterol, Zocor, Simvastatin, Zetia, Vytorin
Baycol is a member of the cholesterol-lowering family of lipid-lowering drugs called statins. In 2001, Bayer Pharmaceutical Division voluntarily withdrew Baycol from the market because of a severe, sometimes fatal side effect, rhabdomyolysis. Rhabdomyolysis is characterized by muscle cell deterioration and the release of those cells into the bloodstream. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. Fatal rhabdomyolysis related to Baycol is more common in older patients, when Baycol was taken in higher doses or when used with gemfibrozil, another lipid-lowering drug.
Baycol Lawsuits Exceed $1 Billion
When the Food and Drug Administration (FDA) gave Bayer Pharmaceuticals approval for Baycol in 1997, the company had only conducted drug testing on approximately 3,000 people. Before the approval and release of Baycol, similar other drugs known as statins had been seen to cause patients some heath problems and serious side effects. Baycol was prescribed to approximately 700,000 people prior to its removal from the market in 2002, with thousands of them claiming that the drug caused rhabdomyolysis or other serious illnesses.
Critics have stated that if the FDA had insisted on more extensive research prior to the approval of the medication, some of the serious side effects or the over 100 deaths linked or associated to the use of Baycol could have been avoided. Claims have also been made that had further tests been administered, it would have been discovered that elderly people appeared to be much more at risk for rhabdomyolysis from the drug than younger people. The FDA has since revised some of its processes and approval procedures and most new drug testing is now much more extensive. Additional reforms and changes are currently in process at the FDA or are under investigation.
In filings with the Securities and Exchange Commission (SEC) in March 2006, Bayer disclosed that it had recently received a subpoena in connection with an earlier federal subpoena over Baycol. Bayer stated in the filings that the company had exhausted its insurance coverage and that it could be subject to further payments in 5,900 pending lawsuits. To date, the company has paid approximately $1.138 billion to settle 3,017 personal injury cases worldwide stemming from Baycol with the individual settlements averaging about $375,000. The lawsuits contain claims for failure to warn, strict liability, negligence, and breach of warranty. The damages being sought against Bayer include compensation for physical and mental pain and suffering, medical expenses, and lost earnings and earning capacity. The company has stated numerous concerns over its significant financial exposure in the thousands of remaining cases in and outside of the country.
When Baycol was removed from the market, it accounted for 3.5% of the market share of anti-hypercholesterolemia or statin drugs in the U.S. These cholesterol limiting drugs are one of the fast-growing segments of the drug industry with sales of $20 billion anticipated when results have been completed for 2005 from $14 billion in 2000. Trend reports indicate that sales of these drugs will continue to climb. The seven statins currently on the U.S. market include Crestor, Vytorin, Zocor, Mevacor, Pravachol, Lipitor, and Lescol. The number one and two most popularly prescribed drugs in 2004 were Lipitor and Zocor with the others all maintaining or growing in numbers. All statins have been connected in some manner with rhabdomyolysis and other side effects that need to be monitored by those taking the medication and by their prescribing physician.
It is recommended that patients or family members of an individual who took Baycol first contact their physician about any serious side effects. Then any individual or family member that believes they may have been harmed or suffered adverse heath effects from the usage of Baycol should seek the advice of an attorney who specializes in unsafe drug litigation.
Serious Side Effects Associated with Baycol
Millions of Americans suffer from high cholesterol. High cholesterol is caused in part by genetics and may run in families; however, it is often caused by an unhealthy diet high in saturated fats and calories, accompanied by a lack of physical exercise. There are also reports that smoking can contribute to higher levels of cholesterol. The factors that contribute to high cholesterol are all inter-related.
Baycol, generically known as Cerivastatin, is a cholesterol-lowering drug manufactured by the Bayer Pharmaceutical Division. Baycol, initially approved in 1997, is a member of a class of cholesterol lowering drugs that are commonly referred to as Statins. Statins combat cholesterol by blocking a specific enzyme in the body that synthesizes cholesterol. While all statins are accompanied by some risk of Rhabdomyolysis, a disorder that causes the breakdown of muscle fibers, the use of Baycol carries a significantly higher risk of the disorder occurring. This is especially true when Baycol is taken in high doses and when used by the elderly.
Specifically, Rhabdomyolysis is a disorder that causes the breakdown of different muscle fibers, which then cause the broken-down muscle contents to release toxic cells into the blood stream. In very rare instances, Rhabdomyolysis may result in kidney damage and other organ damage that may be fatal.
Symptoms of Rhabdomyolysis include:
• Muscle pain, weakness and tenderness (often in calves and back). The pain may be more generalized.
• General feelings of debilitation or overall sickness
• Dark urine
According to the Food and Drug Administration (FDA), reports of 31 deaths due to severe rhabdomyolysis associated with the use of Baycol have been received. Twelve of these deaths were due to mixing Baycol with another cholesterol-lowering drug known as gemfibrozil. In 2001, because of these reports, Bayer Pharmaceutical removed Baycol from the market. Pharmacies were requested to return their stock of Baycol for a refund, and patients using the drug were advised to discontinue use immediately.
There have been various lawsuits and settlements associated with the use of Baycol and the resulting problems of Rhabdomyolysis. In 2004, a $69.9 million global settlement was made on behalf of 122 plaintiffs registering the complaint of pharmaceutical product liability. Additionally, another $68.5 settlement was made on behalf of 168 people who were injured by Baycol. These are only two examples of settlements that have been made by Bayer Pharmaceuticals. As of 2003, Bayer had reportedly spent upwards of $500 million to settle various claims of injury and illness associated with the use of Baycol.