Baycol Recall
Baycol is a cholesterol-lowering prescription drug that was voluntarily removed from the market in August, 2001 by its manufacturer, Bayer Corporation. The company’s decision was based on studies that found the drug increased the risk of fatal rhabdomyolysis, a severe, adverse muscle reaction.
The FDA approved the use of Baycol in 1997. Prior to its removal from the shelves, the drug was widely prescribed. It is part of a group of drugs called statins, which includes brand names such as Lipitor and Vytorin. Statins help lower cholesterol in people with or at risk of developing cardiovascular disease by blocking a liver enzyme that is involved in cholesterol production. Other statins have been linked to rhabdomyolysis, but the occurrence of this reaction in Baycol users is significantly higher.
The actions of Bayer Corporation during the time Baycol was in use may provide evidence it was aware of the drug’s dangerous side effects. Two years after Baycol’s approval, Bayer issued a warning stating the drug could not be used with gemfibrozil, a drug also used to reduce cholesterol, due to the risk of a drug interaction. In May, 2001, Bayer altered the label to change the prescribing directions again. This time it recommended a reduced dosage and also included a warning that Baycol may increase a patient’s risk of rhabdomyolysis. Though Bayer did include a warning on Baycol’s label, the FDA recommended removing the drug after a study found more than 30 people had died from rhabdomyolysis.
Rhabdomyolysis
Rhabdomyolysis is a condition in which muscle cells break down and release toxic chemicals into the bloodstream. Symptoms include:
- Muscle weakness
- Fever
- Dark Urine
- Nausea
- Localized muscle pain in the calves and lower back
Extreme and untreated cases of rhabdomyolysis can lead to fatal muscle toxicity, which can result in severe kidney or other organ failure and, potentially, death.
Bayer’s inability or unwillingness to properly protect its consumers and immediately remove the drug from the market once it was aware of the increased risk of rhabdomyolysis is an act of extreme negligence. Patients assume the medications they are prescribed are designed to solve certain problems – not add to them. Bayer’s failure to properly warn and protect the public may make it liable for any illness or death caused by individuals who have taken Baycol.
If you or someone you know has suffered the effects of rhabdomyolysis as a result of taking Baycol, contact the lawyers of Levin, Simes, Kaiser & Gornick at (800) 901-4001 to learn more about your legal rights and the possibility of compensation.
Levin Simes Kaiser & Gornick, LLP
44 Montgomery Street, 36th floor
San Francisco, CA 94104
Ph: 1.800.901.4001
Fax: 415.981.1270
