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Statin labels will get new safety warnings
Mar 01, 12 FDA warningsAn entire class of statin drugs will get new labels that alert the public to safety concerns, the Food and Drug Administration announced Tuesday.
Statins, which treat cholesterol, now will come with labels that include a warning that the drugs, taken by almost 32 million Americans, can cause memory loss and confusion. The FDA says reports in general have not been serious, and the symptoms subsided when patients stopped taking the medications.
The new labeling will also warn doctors and patients that Statins can cause hyperglycemia, an increase in blood sugar levels and increase the risk of Type 2 diabetes.
The FDA will no longer recommend routine and periodic monitoring of liver enzymes of patients taking Statins. Instead, it said liver enzyme tests should be performed before a patient starts taking Statins, and then only when clinically indicated. That’s because according to the FDA, serious injury to the liver is rare, and routine monitoring doesn’t detect or prevent it. The new label will tell patients who experience fatigue, loss of appetite, dark urine, upper stomach pain or jaundice to notify their doctor immediately.
There also will be a label change specific to lovastatin (Mevacor). Certain medicines interact with this particular statin, increasing the risk of myopathy, or muscle damage. The agency says some drugs should never be taken with Mevacor including protease inhibitors, a class of HIV drugs and certain drugs used to treat bacterial and fungal infections.
“We want healthcare 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,” said Dr. Mary Parks, in the FDA’s Center for Drug Evaluation and Research.
Statins are used to prevent and treat Atherosclerosis, the build up of plaque on the inside of blood vessels causing them to become thick and hard. The result can be heart attacks and stroke. Statins help lower low-density lipoprotein cholesterol, or “bad” cholesterol. The products that will have these label changes include Lipitor (atorvastatin), Mevacor (lovastatin), Crestor (rosuvastatin) and Zocor (simvastatin). Labels for combination statin products like Advicor, Simcor and Vytorin will also change.
Lipitor, which became available late last year in generic form as atorvastatin, is the world’s all-time biggest selling prescription medicine with cumulative sales of over $130 billion.
The generic version of Zocor, simvastatin, in 2010 was the second most widely prescribed drug in the United States, according to IMS Health.
The FDA said it was aware of studies in which some patients taking Statins may have a small increased risk of higher blood sugar levels and of being diagnosed with type 2 diabetes.
Statins are a class of medicines that are frequently used to lower blood cholesterol levels. The drugs are able to block the action of a chemical in the liver that is necessary for making cholesterol. Although cholesterol is necessary for normal cell and body function, very high levels of it can lead to Atherosclerosis, a condition where cholesterol-containing plaques build up in arteries and block blood flow. By reducing blood cholesterol levels, Statins lower the risk of chest pain (angina), heart attack, and stroke.
Several types of Statins exist such as atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin. Atorvastatin and rosuvastatin are the most potent, while fluvastatin is the least potent. These medicines are sold under several different brand names including Lipitor (an atorvastatin), Pravachol (a pravastatin), Crestor (a rosuvastatin), Zocor (a simvastatin), Lescol (a fluvastatin) and Vytorin (a combination of simvastatin and ezetimibe). Mevastatin is a naturally occurring statin that is found in red yeast rice.
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