BAYCOL

On August 8, 2001, the Bayer Corporation, with headquarters in Pittsburgh, PA, withdrew the prescription cholesterol lowering drug BAYCOL from the United States market, citing ever increasing "reports of side effects involving muscle weakness (rhabdomyolysis)...." (See, Bayer Statement of August 8, 2001).
Also (See, FDA Talk Paper). 

The drug appeared to be responsible for 31 deaths connected to its use. (See "Bayer Pulls its Cholesterol-Lowering Drug Baycol Off the Market". 

Rhabdomyolysis is, according to the United States Food and Drug Administration, "...a very rare condition where serious muscle damage results in release of muscle cell contents into the bloodstream. On very rare instances, rhabdomyolysis may result in kidney damage and other organ damage which may be fatal." (See, "FDA/Center for Drug Evaluation and Research", August, 2001 Question and Answers Regarding BAYCOL). 

Rhabdomyolysis is a disorder involving injury to the kidney caused by toxic effects of the release of myoglobin (an iron containing pigment found in skeletal muscle). Rhabdomyolysis can cause:

• occlusion of the structures of the kidney

• Death, from kidney failure

• Kidney damage, sometimes irreversible

• acute tubular necrosis

• shock (toxic)

     (See, Brown & Szaller’s Questions and Answers Regarding BAYCOL)

     The signs and symptoms of rhabdomyolysis can include, inter alia:

• Muscle pain, weakness or tenderness, most frequently in the calves or low back (although sometimes there is no sign of muscle weakness)

• Fever, rapid heart beat, nausea, and vomiting

• Dark or red urine

BACKGROUND: BAYCOL (cerivastatin) was approved by the FDA for marketing by Bayer in the United States on June 26, 1997. A 1998 press release (See, Feb.18, 1998 Press Release) hailed the statin class drug as a:"...new cholesterol-lowering agent...indicated as an adjunct to diet for the reduction of elevated total and low-density lipoprotein cholesterol (LDL-C) levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson types IIa and IIb) when response to dietary restriction of saturated fat and cholesterol and other non-pharmacological measures alone have been inadequate..."

On July 24, 2000, the FDA approved new dosages and indications. (See, July 24, 200 Press Statement). Prescribing information changes were advised (See, May 21, 2001 Bayer letter to health professionals), but about a year later, Bayer informed health professionals that because of the adverse effect of rhabdomyolysis the drug was being removed from the market. (See, August 8, 2001 letter from Bayer to health professionals).

TODAY: It is known that the drug has caused a much higher incidence of rhabdomyolysis than other statin cholesterol-reducing drugs. But what is not known (yet) is: (1), why it is more dangerous than other statin drugs; (2), how many people using the drug actually have become severely ill, or died: (3), what the manufacturer knew (or should have known) about the drug’s propensity to cause disease; (4), whether the manufactuer’s testing, and pre and post-marketing surveillance, have been adequate: and(5), whether others involved in the development, marketing, sales and distribution share responsibility for the illnesses and deaths apparently related to use of the drug. The answers to these questions will be determined by the investigations of lawyers retained by people injured by BAYCOL.

If you or a family member took BAYCOL and were injured, or died, contact Brown & Szaller (click here to email Brown & Szaller, or call 1-888-517-2249) for information. We are experienced in complex product liability and medical litigation (See, Verdicts and Settlements). We will determine if the drug caused injury or death to our clients and their families, and whether they are entitled to compensation. We can help, without putting you at risk-- unless we recover money for you, you owe us nothing.