Cholesterol Drugs Warning Label

March 1, 2012 by staff 

Cholesterol Drugs Warning Label, The Food and Drug Administration has added new warnings to the statin class of cholesterol-lowering drugs and one longstanding precaution has been removed.

New Safety Warnings for Statin Drugs

Anti-cholesterol medications such as lovastatin and simvistatin — classified as statin drugs — and combination medications such as Vytorin that include a statin component, will be required to include warnings about the potential risks of confusion and/or memory loss and elevated blood sugar levels, according to the FDA.

Both of these risks are considered to be small, reports the federal agency, and the confusion/loss of memory generally go away once the statin drug is discontinued. The slight risk of blood sugar levels being adversely affected may lead to the development of Type 2 diabetes.

Precaution Removed

For people taking statin drugs, it has long been recommended by the FDA they receive periodic liver function tests to prevent or detect serious liver injury. But the agency has determined that such injury is rare and unpredictable; the blood tests were not helpful in either detection or prevention of the condition.

The agency now recommends that a liver function test is performed before a statin drug is prescribed so that any concern about liver condition can be determined before initiating therapy.

Widespread Use of Cholesterol-Reducing Medications reports Lipitor leads the world in prescription sales of more than $130 million; Zocor was the second most frequently prescribed drug in the U.S. in 2010.

The popularity of the statin drugs among physicians and patients likely correlates to the fact that heart disease and stroke remain the leading causes of death in the United States, according to the Centers for Disease Control and Prevention.

Baby boomers and their seniors are a large portion of the statin-taking public, with more than 150,000 people under the age of 65 dying from cardiovascular disease in 2007, as reported by the CDC. Reducing cholesterol levels is an important factor in the prevention of both heart attacks and strokes.

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