Cholesterol-Lowering Baycol:
What You Didn't Know

By David Fonvielle, Partner

As you may be aware, Bayer recently pulled its cholesterol-lowering medicine, known as Baycol, off the market. If you are taking Baycol, call your prescribing physician immediately.

Bayer pulled Baycol from the market in early August, announcing that the drug was associated with 31 deaths in the United States and at least nine deaths in other countries. Of the 31 deaths referred to by Bayer, 12 occurred when patients used Baycol in combination with gemfibrozil, another cholesterol-lowering drug. Bayer announced it received reports that Baycol caused deterioration in muscle tissue resulting in rhabdomyolysis, a condition known to cause severe pain and potential kidney failure.

Initial appearances can be deceiving. From reading the Bayer press releases, it certainly appeared Bayer was being vigilant and doing the right thing in light of the reports of death and rhabdomyolysis, which presumably were unanticipated by Bayer. Unfortunately, the more we research these issues, the less it appears that Bayer was ÒsurprisedÓ by the deaths and rhabdomyolysis experienced by patients taking Baycol.

Baycol is one of a group of drugs known as statins. These drugs include other cholesterol-lowering drugs such as lovastatin, simvastatin, pravastatin, fluvastatin, and atrovastatin. These drugs work by slowing down the cholesterol-manufacturing process in the liver by interfering with the helper enzyme that controls the rate of production of cholesterol. The higher the activity of this enzyme, the more cholesterol is made; the lower the activity, the less cholesterol is made. Over recent years the ability of these medications to control cholesterol in persons experiencing high cholesterol levels has been nothing short of miraculous.

The Side Effects of Statins

Since statins have been in use for many years, the side effects of these drugs are well documented and are well known to the medical community. The Physicians Desk Reference, a resource containing comprehensive information about prescription drugs, provides an overall picture of the known and established side effects of the drugs. Here are some of the details about statins:

• Statins are known to cause "marked persistent increases in serum tranaminases (liver enzymes)" in a small percentage of patients who took certain statins for a one-year period, sometimes resulting in severe liver damage.
• Statins are known to cause muscle destruction (rhabdomyolysis), especially when taken with gemfibrozil or lipid-lowering doses of niacin.
• Statins are known to cause acute kidney failure when combined with gemfibrozil.

If these side effects sound familiar, you are right. Looking back to the announcement by Bayer withdrawing Baycol from the market, the reasons were that Baycol could cause "severe muscle pain," "sometimes fatal rhabdomyolysis," and "deaths occurring when patients used Baycol in combination with gemfibrozil." It is puzzling why Bayer appeared surprised that Baycol (a statin) was causing the exact problems that may be caused by all statin drugs. Thus far Bayer has not provided a valid response to this issue.

Alerting the Public

While we were investigating the Baycol withdrawal, an attorney in Tallahassee referred a client to us who had taken Baycol combined with gemfibrozil and suffered severe rhabdomyolysis. After reviewing this client's situation, we realized the injuries might be much worse and more prevalent than we believed based on the announcement to withdraw Baycol from the market. We began to wonder how many people were similarly injured as the result of Baycol.

We discovered that there appears to be more people who died from kidney failure while taking Baycol than Bayer initially reported.

Over the years, we found the best method for determining what the effects of a defective product has on the public is to let them know we are available to assist them if they believe they were injured by the product.

Therefore, we initiated a public awareness campaign using TV and newspapers to advise the public that we are available to help anyone who believed they had been injured as the result of taking Baycol. As a result of our campaign, we discovered that there appears to be more people who died from kidney failure while taking Baycol than Bayer initially reported. Additionally, we talked with hundreds of people who suffered severe and, in many instances, disabling muscle pain (rhabdomyolysis), kidney failure and dialysis and liver problems while taking Baycol. Fortunately, for the majority of these patients, the adverse effects of the Baycol subsided when they discontinued using the drug. Regrettably a few continue to experience pain and weakness or have suffered

permanent kidney damage. We accepted many of these Baycol victims as clients and are proceeding with the necessary litigation.

Cases such as these are generally defended vigorously, but in this day and age, one would think Bayer, although sitting comfortably in Germany, probably realizes its size, status, wealth, and tactics do not translate in to an advantage in our court system. It shouldn't be long before depositions and productions of documents will begin and the facts will be revealed. Sadly for our many clients, even though we may win their case in litigation, we will not be able to restore the loss of health and quality of life that this dangerous drug has taken from them.

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Fonvielle Lewis Foote & Messer
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Telephone: 850-422-7773 | Fax: 850-422-3449
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