How Safe are Statins?
Excerpt from the January 2002 issue of The Newsletter of The American Institute of Stress
Last August, the Public Citizen's Health Research Group petitioned the FDA to add a "black box" warning to all statin packaging that would be in bold type surrounded by a black box to make it stand out. The agency should also require that additadditional warnings in bold type be added to the package inserts of these products. In addition, they should require that a medication guide be distributed to all patients filling statin prescriptions advising them to immediately stop using the drug if they experience muscle pain, tenderness, weakness or tiredness. Finally, drug companies should be required to send "dear doctor" letters to all health care professionals about the risk of muscle damage due to statins.
According to the group's director, "labeling on statins is inconsistent and dangerously inadequate. Most people taking these drugs aren't aware that they could sustain serious muscle damage and could even die from taking these drugs." These warnings are particularly necessary in light of the recent government report recommending that 23 million more people take cholesterol-lowering drugs, including many with normal cholesterol and LDL values. One day after Baycol was banned the European Medicines Evaluation Agency announced they would establish an Advisory Panel composed of one representative from each European union member state to conduct a safety review of other statin drugs. This panel has no authority to enact any changes and can only make recommendations.
There is evidence that statin side effects are increased and are more severe in older patients as well as those who also take other drugs to lower cholesterol and triglycerides, like Lopid (gemfibrozil). It also seems quite clear that side effects are directly related to dosage, which could prove to be a serious problem. The goal of therapy is to lower LDL to an arbitrary level despite overwhelming evidence that statin cardioprotective benefits are not related to effects on any lipid concentrations. This means that the dosage and duration of treatment will be steadily increased if the desired result is not achieved.
Paul J. Rosch, M.D., F.A.C.P.
President, The American Institute of Stress
Clinical Professor of Medicine and Psychiatry
New York Medical College
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