Zocor 80mg fda warning
Zocor 80mg fda warning
FDA issues warning for high doses of Zocor. In 2008, the FDA cautioned against using doses of Zocor greater than 20 mg. Approval: 1991 -----RECENT MAJOR CHANGES -----Dosage and Administration Chinese Patients Taking Lipid-Modifying Doses (≥1 g/day Niacin) of Niacin-Containing Products (2. Food and Drug Administration warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg ZOCOR 80 mg daily dosage is restricted to patients who have been taking ZOCOR 80 mg daily chronically (e. In June 2011, the FDA placed restrictions on the use of 80 mg Zocor, which could include twice-a-day 40mg doses, due to the risk of myopathy and rhabdomyolysis, warning doctors that no new patients. Muscle injury is a known side effect for statins, but the FDA said its warning highlights increased risks for 80-milligram Zocor, in particular for a serious form of injury that can lead to severe. The agency singled out atorvastatin (Lipitor), rosuvastatin (Crestor), and simvastatin (Zocor) for the new warnings and restated a warning about mixing lovastatin (Mevacor) with HIV and HCV drugs. In June 2011, FDA restricted the use of the highest approved dose of simvastatin (80 mg) to. Requests to FDA for agency records zocor 80mg fda warning should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Simvastatin (Zocor) is used to treat high cholesterol and to reduce risk of heart disease. Warnings In rare cases, Zocor can cause a condition that results in the breakdown of skeletal muscle tissue, potentially leading to kidney failure [06-08-2011] The U. Last Update: May 13th 2017 Data sources: Label (May 13th 2017) , National Institutes of Health (June 8th 2015) , FDA (May 31st 2015) MyRx. Regulators warned on Friday The federal safety agency said Tuesday it plans to add the diabetes-risk language to the "warnings and precautions" sections of labeling for the statin drugs. You may report side effects to FDA at 1-800-FDA-1088 UPDATE: FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury [06-08-2011] The U. 1) ] There is an increased risk of myopathy associated with high-dose (80 mg) simvastatin. Treatment, use of the 80mg dose of ZOCOR should be restricted to patients who have been taking - simvastatin 80 mg chronically (e. 1) ] FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor, (simvastatin) and increased risk of muscle injury FDA Warns about Increased Risk of Muscle Injury with Zocor Statement to. Are not affiliated with the FDA or with Merck Sharp & Dohme Corp. Patients on the highest approved dose of the cholesterol-lowering drug Zocor may be at increased risk of muscle injury, U. Food and Drug Administration (FDA) is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin (80 mg) because of increased risk of muscle damage [ i. Food and drug administration (fda) is informing the public about an increased risk of muscle. 9%) and the FDA is urging patients to NOT stop taking Zocor, but to be aware of the risk and discuss the benefits and risks with their physician. Food and Drug Administration (FDA) is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin (80 mg) because of increased risk of muscle damage. Food and Drug Administration (FDA) is notifying the public that it has revised the dose limitation for the cholesterol-lowering drug simvastatin from 10 mg to 20 mg when it. Simvastatin is sold under the brand-name Zocor and as a single-ingredient generic product The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction. Learn about side effects, dosage, uses, and more ZOCOR: SIMVASTATIN: TABLET;ORAL: 80MG **Federal Register determination that product was not discontinued or Other Important Information from FDA. WASHINGTON (Reuters) - Patients on the highest approved dose of the cholesterol-lowering drug Zocor may be at increased risk of muscle injury, U. Food and Drug Administration (FDA) is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin (80 mg) because of. ZOCOR 80 mg daily dosage is restricted to patients who have been taking ZOCOR 80 mg daily chronically (e. , for 12 months or more) without evidence of muscle toxicity. • Tablets ZOCOR 40 mg are brick red, oval, film-coated tablets, coded MSD 749 on one side and plain on the other The risk at 80 MG is still under 1% (. [3-19-2010] based on review of data from a large clinical trial and data from other sources, the u. O For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving ZOCOR 40 mg daily, prescribe alternative LDL-C lowering treatment • Tablets ZOCOR 10 mg are peach, oval, film-coated tablets, coded MSD 735 on one side and plain on the other. O For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving ZOCOR 40 mg daily, prescribe alternative LDL-C lowering treatment Find how to get a pepcid prescription from your doctor everything you need to know about Zocor including what it is used for, warnings, reviews, side effects, and interactions. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient’s needs. , for 12 months or more) without evidence of muscle toxicity [see Warnings and Precautions (5. Very rarely, statins can cause life-threatening muscle damage called rhabdomyolysis (rab-doe-my-OL-ih-sis). In combination with the anti-arrhythmia drug amiodarone, sold under the brand names Pacerone and Cordarone ZOCOR 80 mg daily dosage is restricted to patients who have been taking ZOCOR 80 mg daily chronically (e. 2) ------------------------------ ADVERSE. ) and reports of increased blood sugar and.