FDA warns of potentially harmful statins

The U.S. Food and Drug Administration is warning consumers of potentially harmful statins found to be adulterating three red yeast rice products being sold on the web as all-natural dietary supplements to lower cholesterol. A laboratory analysis by the FDA found the products contained significant levels of the prescription drug lovastatin.

It issued Warning Letters to companies selling them: Swanson Health Products, Inc. and Sunburst Biorganics, for marketing unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act.

In a media release, Dr. Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research, said: “This risk is even more serious because consumers may not know the side effects associated with lovastatin and the fact that it can adversely interact with other medications.” According to their media release:

These red yeast rice products are a threat to health because the possibility exists that lovastatin can cause severe muscle problems leading to kidney impairment. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.

The adverse effects of prescribed statins can be significant enough, but there is even greater danger for special groups of people who might take these all-natural health supplements unsuspecting that they contain a statin. Statins are especially risky for women of childbearing age who may become pregnant. Among 48 cases in a postmarketing study, there was a reported:

Three (6.3%) spontaneous abortions, one (2.1%) stillbirth, four (8.3%) infants with congenital anomalies (atrial or ventricular septal defects, cerebral dysfunction, VATER complex, spina bifida, and holoprosencephaly), 39 (81.2%) normal outcomes, and one case of pedal edema.

As previously reported in reviews of the risks and benefits, lovastatin has been found to be among those cholesterol medications carrying the highest propensity to cause myopathy, according to Dr. Eliot A. Brinton, M.D., Director of the Metabolism Section of Cardiovascular Genetics, and Associate Professor at the University of Utah School of Medicine, Salt Lake City, Utah. Statins hold special considerations not only for women, but for kids, the elderly, and when prescribed population-wide.

The Statin Effects Study at the University of California, San Diego, offers more detailed information on the most well-known problems experienced by patients, beyond the muscle problems and kidney problems noted by the FDA in its announcement. These side effects aren’t always recognized by doctors, though, which is why patient education is so important. On man recently released a YouTube video of the side effects he and other men have experienced with statins, along with what he and his wife have learned, in hopes that others can benefit from his experience. You may view it here: http://uk.youtube.com/watch?v=7KD7omFDAKo

The FDA cautions consumers who use any red yeast rice product to consult their doctors if they experience any problems.