Bayer AG pulls Cholesterol Drug Baycol

Reuters news service reports on August 8, 2001 that German drug company Bayer AG has taken its controversial cholesterol drug Baycol off the market after 31 people taking the drug died from a rare muscle-cell disorder.

The FDA reports that it agreed with the decision. Baycol (chemical name cerivastatin), is in a class of cholesterol drugs called statins, and was approved for use by the FDA in the United States in 1997.

The muscle-cell disorder is called rhabdomyolysis and causes muscle-cell breakdown, muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea and vomiting. In extreme cases rhabdomyolysis is so severe that patients can develop kidney and other organ failure leading to death.

In a related story on August 20, 2001, Reuters Health news service reported that the Washington DC-based consumer advocacy group Public Citizen has filed a petition with the FDA urging them to require a 'black box warning' on all statin drugs. 'Black box warnings' are the strongest labeling caution the FDA can require.

The statin drugs that Public Citizen wants labeled are Pravachol (pravastatin), Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin) and Zocor (simvastatin).

Oddly after Bayer pulled Baycol, the FDA suggested that doctors switch their patients to these other statin drugs, but they have also been associated with hundreds of recent reports of rhabdomyolysis as well. 772 cases of rhabdomyolysis associated with all of the statins were reported between October 1997 and December 2000, accounting for a total of 81 deaths.

By way of commentary, we seriously question the wisdom of the FDA who first approves the drug, then agrees that it needs to be taken off the market, then tells doctors to substitute other drugs for the drug that was taken off the market with ones that are similar but are causing the same type of problems that gave reason for the original drug to be withdrawn in the first place. Does any of this make any sense to anyone?

You could consider Cod Liver Oil (or Flax oil) taken daily.  You might also  consider exercise and dietary modification long before you even think about drugs. I think most doctors, if asked, would agree with this.  But on a busy day at the clinic it may be easier for them to just write a prescription.