Baycol
My drug of choice for this research paper is Cerivastatin sodium, more commonly known as Baycol. Cerivastatin is a synthetic member of the statin drug class and is used to lower cholesterol and prevent cardiovascular disease (Wikipedia.com). I would like to inform you today about the downfall of Baycol and help you to understand why this was taken off the market. Baycol was originally prescribed to help total Cholesterol levels and as we have learned in class, Cerivastatin is part of the “statin” drug class and the dangers of prolonged use.
As I will explain later, the continued use of this statin has led to rhabdomyolysis, or breakdown of the muscle tissue.
“Baycol won FDA approval in 1997 and became the fastest-growing drug in Bayer’s history. By the time it was pulled, it was Bayer’s No. 3 seller, expected to earn some $720 million that year with 6 million patients worldwide, including 700,000 in the United States (apnews.com) “. It was later discovered that Bayer knew about the dangerous side effects but chose to ignore it due to tremendous profit potential.
Baycol accounted for 60 % of worldwide statin sales in early 1998. Needless to say, Bayer took a huge profit loss when Baycol was taken off the market. Within the span of ten years, Bayer had introduced several forms of Statins within the United States market, some are still in use today, some like Baycol is not. Some studies have associated higher level of Baycol taken with Gemfibrozil, has shown to increase the risks of Rhabdomylosis, as well as kidney failures.
What does it do to the body?
Cerivastatin was originally prescribed to help lower cholesterol, as you know having high cholesterol can lead to many health issues such as coronary heart disease. How does it do that exactly? Well I’m glad you ask, in general, Baycol helps to lower total cholesterol levels. It does this by reducing the good bad and the ugly decreases LDL (bad) increases HDL (good) and helps to reduce triglycerides (fats) in the blood. These essential components are important in reducing the hardening of arteries. As we have studied in previous chapters, the hardening of arteries can lead to heart attack, stoke and other vascular diseases. This medicine alone does not do all the work, we are still to follow a healthy diet and exercise to keep cholesterol levels close to normal as we possibly can.
What are the long-term effects on the body?
Rhabdomylosis, as defined by medlineplus.gov, is the breakdown of muscle tissues. As we have studied in previous chapters, myoglobin is produced when muscle fibers are broken down and is released into the bloodstream. More about this process in my next point, There are some cases where kidney failure can lead to death, as such the case of Baycol.
Why was it recalled?
One of the main reason Baycol ( cerivastatin ) was recalled from the market is that leads to death. After myoglobin enters the kidneys and is processed in the kidney tubules if the tubules are blocked nothing is allowed to enter the kidney. Once in the bloodstream, and is filtered by the kidneys, can lead to acute renal failure. The kidney cannot process the high concentration of urine and properly remove wastes, once this occurs the kidneys will simply shut down completely. Kidney failure occurs and if left untreated leads to death. 52 deaths were reported due to use of Baycol. A lot of these deaths were attributed to the strength of the drug taken,
Bayer the company that makes Baycol has been sued many times due to their ignorance is not telling the public about the dangerous side effects of the drug. Bayer was found on numerous occasions that they withheld vital warnings and necessary test for the regulatory committee. In this case, Bayer was more interest in profit than the public’s health. Following a class action lawsuit, Bayer took a huge financial hit, in 2007 they agreed to pay out $ 8 million to people in thirty states who in some form suffered ill effects of Baycol.
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