Posts Tagged ‘Diabetes’

FDA Cautions On Memory, Diabetes Side Effects In Cholesterol-Lowering Drugs

Saturday, March 17th, 2012

The Food and Drug Administration just add

ed new language telling consumers about potential memory problems and an increased risk of high blood sugar for patients on statin cholesterol-lowering medicines. These medicines, including Lipitor, Zocor, and Crestor, are the most-prescribed class of drug in the country. According to drug data firm IMS Health, 255 million prescriptions for cholesterol-lowering drugs were written in 2010.

According to the FDA, the changes to the statin labels are:

* 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 anyone you know has been hurt by Lipitor, Zocor or Crestor; call us at 877 882 0095

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Feds Slap New Warnings on Cholesterol-Lowering Statins, Including Diabetes Risk

Friday, March 9th, 2012

U.S. health officials will be adding new safety warnings of memory loss, confusion, high blood sugar, and type II diabetes as possible side effects to popular cholesterol-lowering drugs called statins, the U.S. Food and Drug Administratio

n anno

unced on Tuesday.

The FDA on Tuesday also removed the requirement that health care providers must monitor patients’ livers because serious liver injury is “rare” with statins, the agency said in a statement.

The new safety labels of statins like Pfizer’s Lipitor, AstraZeneca’s Crestor and Merck & Co. Inc.’s Zocor, must now contain information that warns patients of the risk of cognitive impairment, mental confusion, risk of high blood sugar and risk of being diagnosed with type II diabetes.

The health agency also singled out lovastatin, sold under the brand name Mevacor, with an additional warning for risk of muscle damage. All statin medications have a small risk for muscle injury, but the FDA said that this risk is especially high for patients taking lovastatin along with certain other drugs for HIV and some antibiotics.

“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,” Mary Parks, MD, director of the FDA’s Division of Metabolism and Endocrinology Products, said in a news release.

The products subject to FDA’s new labeling requirements include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).

However, the FDA stresses that the new information should not “scare people off” statins.

Statins have been shown to significantly reduce the risk of heart attack and heart disease, said the deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products, Amy Egan, and that “their benefit is indisputable” but patients need to know about the drugs side effects and that statins “need to be taken with care”.

If you or anyone you know has been hurt by Statin, call us at: 877 882 0095

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