Statins Labels Changed By FDA Due To More Side Effects

Editor's Choice
Main Category: Statins
Article Date: 28 Feb 2012 - 17:00 PST


A recent announcement released by the Food and Drug Administration (FDA), claims that statins, drugs taken to lower cholesterol, may cause various health problems. According to IMS Health, over 20 million Americans were taking some type of statins last year.

The following drugs are statins:

• Lipitor (atorvastatin)
• Lescol (fluvastatin)
• Mevacor (lovastatin)
• Altoprev (extended release lovastatin)
• Livalo (pitavastatin)
• Crestor (rosuvastatin)
• Livalo (pitavastatin)
• Zocor (simvastatin)
• Simcor (simvastatin/niacin extended release combo)
• Advicor (lovastatin/niacin extended release combo)
• Vytorin (simvastatin/exetimibe combo)

Mary Parks, M.D., director for the Division of Metabolism and Endocrinology Products at the Office of Drug Evaluation ll in FDA's Center for Drug Evaluation and Research said:

" 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. "

Previously, statin labels recommended that patients consuming the drugs should be receiving regular liver enzyme monitoring tests. However, the FDA has changed this part of the label, stating that a patient should be tested before they start the medication, and if necessary, after, as well. This is because the FDA has come to the conclusion that random liver enzyme monitoring has not worked in the past, due to the fact that uncommon, serious liver injury from statins is unpredictable and dangerous.

The following are symptoms of liver problems, and as recommended by the FDA, should be reported immediately to a doctor:

• upper stomach pain
• weakness
• tiredness
• change in appetite
• dark urine
• yellowing of the eyes or skin

In addition to liver damage, cognitive effects (having to do with the memory and thinking), have become a problem, due to statin use as well. The FDA has also added wording on the label of statins containing key information in relation to the reports of memory loss and confusion. The FDA claims that no serious problems related to memory loss and confusion have occurred with the use of statins, and the problems ceased when the patient stopped the statin treatment, but patients should be cautious if they start and immediately report the symptoms to their doctor.

The FDA has added other warnings on the label, including increased blood sugar levels, or hyperglycemia, and the risk of type 2 diabetes mellitus.

In particular, the lovastin label has been changed with regard to combining it with other medication. The FDA says that HIV drugs (protease inhibitors) or medicine for fungal and bacterial infection, should not be taken while the patient in also taking lovastatin, because of the high risk of injury of the muscles.

The FDA urges anyone who is having problems with statins to immediately notify their doctor.

Written By Christine Kearney


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Not to be reproduced without permission of Medical News Today

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