Posted by: Salvatore J. Zambri, founding member and partner
The Food and Drug Administration (FDA) has now officially linked cholesterol-reducing drugs to cognitive problems, diabetes and muscle pain. Some important safety labeling changes are now to be included on these drugs, generally known as statins, including Lipitor, Lescol, Mevacor, Altoprev, Livalo, Pravachol, Crestor, and Zocor, as well as several combination products.
According to the director for the Division of Metabolism and Endocrinology Products in the Office of Drug Evaluation II in FDA’s Center for Drug Evaluation and Research, “We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol."
Currently, more than 20 million Americans take some form of statin medication. While the benefits of these drugs are certainly not disputed, the FDA’s ongoing review of medical literature, clinical trial data and reports of adverse events prompted the new cautions.
Listed below are the specific labeling changes that will be required:
- "The drug labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect. Patients should notify their health care professional immediately if they have the following symptoms of liver problems: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes.
- Certain cognitive (brain-related) effects have been reported with statin use. Statin labels will now include information about some patients experiencing memory loss and confusion. These reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin. However, patients should still alert their health care professional if these symptoms occur.
- Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus. The labels will now warn healthcare professionals and patients of this potential risk.
- Health care professionals should take note of the new recommendations in the lovastatin label. Some medicines may interact with lovastatin, increasing the risk for muscle injury (myopathy/rhabdomyolysis). For example, certain medicines should never be taken (are contraindicated) with Mevacor (lovastatin) including drugs used to treat HIV (protease inhibitors) and drugs used to treat certain bacterial and fungal infections."
If you or a member of your family are currently taking any of the listed statin medications for the reduction of cholesterol, please consult with your personal physician to determine the potential risks of these drugs. Patients should report any side-effects to their physician. As with any medications, do not attempt to quit taking your prescriptions without consulting a medical professional first. Doing so often causes unintended medical complications.
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About the author:
Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year". He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington’s best–most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)–a national publication that honors the top lawyers in the country.
Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.
If you have any questions about your legal rights, please email Mr. Zambri at firstname.lastname@example.org. You may also reach him at 202-822-1899.