Navigation Links
FDA Announces New Safety Recommendations for High-Dose Simvastatin
Date:6/8/2011

SILVER SPRING, Md., June 8, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today is announcing safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose--80 milligram (mg)--has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The agency is recommending that simvastatin 80 mg be used only in patients who have been taking this dose for 12 months or more and have not experienced any muscle toxicity. It should not be prescribed to new patients. There are also new contraindications and dose limitations for when simvastatin is taken with certain other medications.

Simvastatin is used together with diet and exercise to reduce the amount of "bad cholesterol" (low-density lipoprotein cholesterol or LDL-C) in the blood. High levels of LDL-C are linked to a higher risk of heart attack, stroke and cardiovascular death. In 2010, about 2.1 million patients in the United States were prescribed a product containing simvastatin 80 mg.

"The FDA has completed its review of the safety of high-dose simvastatin and is making label changes to reduce the risk of statin-associated muscle injury," said Eric Colman, M.D., deputy director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. "We want to ensure that patients and health care professionals are aware of the new labeling changes to simvastatin, including the increased risk of myopathy when using the 80 mg dose of simvastatin."

The changes to the label for simvastatin-containing medications are based on the FDA's review of the results of the seven-year Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine clinical trial, other clinical trial data, and analyses of adverse events submitted to the FDA's Adverse Event Reporting System. All showed that patients taking simvastatin 80 mg daily had an increased risk of muscle injury compared to patients taking lower doses of simvastatin or other statin drugs. The risk of muscle injury is highest during the first year of treatment with the 80 mg dose of simvastatin, is often the result of interactions with certain other medicines, and is frequently associated with a genetic predisposition for simvastatin-related muscle injury.

Simvastatin is sold under the brand-name Zocor and as a single-ingredient generic product. It is also sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor.

The FDA has revised the drug labels for simvastatin and Vytorin to include the new 80 mg dosing restrictions. The agency also revised the labels for simvastatin, Vytorin and Simcor to include new dosing recommendations when these drugs are used with certain medications that interact to increase the level of simvastatin in the body, which can increase the risk for myopathy. Patients who are unable to adequately lower their level of LDL-C on simvastatin 40 mg should not be given the higher 80 mg dose of simvastatin;  instead, they should be placed on an alternative LDL-C-lowering treatment(s).

For more information:

FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury
http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm

Previous FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm204882.htm

FDA Warns about Increased Risk of Muscle Injury with Zocor
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm205215.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Anthera Pharmaceuticals Announces Completion of Public Offering of Common Stock
2. Morphotek, Inc. Announces That Two Investigational Drugs Have Received Orphan Drug Designations
3. Otonomy Announces Preclinical Results Supporting Intra-operative Use of OTO-201 for Common Childhood Procedure
4. Pharmasset Announces the Expansion of the ELECTRON Trial in Chronic Hepatitis C
5. Grifols Announces Combined Operations With Talecris to Begin a New Era as a Global Leader of Life-Saving Plasma Therapeutics
6. Edison Pharmaceuticals Announces FDA Grants EPI-743 Orphan Drug Designation
7. Boston Scientific Announces Favorable Appellate Court Ruling Affirming Invalidity of J&J Patents
8. Alere Inc. Announces Extension of Consent Solicitations Related to its 9.0% Senior Subordinated Notes Due 2016, 8.625% Senior Subordinated Notes Due 2018 and 7.875% Senior Notes Due 2016 and Increased Consent Fees
9. ImaginAb, Inc. Announces Availability of Custom Protein Radiolabeling Services for Molecular Imaging
10. Topaz Pharmaceuticals Announces New Drug Application for the Treatment of Head Lice Accepted by FDA
11. Ore Pharmaceutical Holdings Announces Name Change and Reverse/Forward Stock Split to be Effective June 10, 2011
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... , Feb. 11, 2016 ... Companion Diagnostics in Personalized Medicine and Cancer Therapy. ... - High-Growth Diagnostic Testing Markets. - Key Diagnostic ... - Molecular Diagnostics in Genetic Testing. - ... Diagnostics Markets. - Over-the-Counter Diagnostic Products World Markets. ...
(Date:2/11/2016)... 2016  Kindred Biosciences, Inc. (NASDAQ: KIN ), ... lives of pets, today announced the submission to FDA ... Drug Application (NADA) for Zimeta™ (dipyrone injection, KIND-012).  Positive ... Zimeta for the control of pyrexia (fever) in horses ... --> --> The Chemistry, Manufacturing, and ...
(Date:2/11/2016)... 2016  NOIT™ Research LLC, a private, leading-edge autism ... campaign to assist needy families in obtaining one of ... between February 10, 2016 and March 31, 2016, the ... The NOIT is an auditory stimulus that plays a ... skills. Beth Shier , NOIT Research ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... Fixed ... p.m. – 3:00 p.m. EST, http://www.fdanews.com/fixeddosecombination , Fixed ... pharmaceutical products, garnering increased attention from all stakeholders in the development of new ...
(Date:2/12/2016)... ... February 12, 2016 , ... T.E.N., a ... closed for the ISE Southeast Awards 2016. Finalists and winners of the ISE® ... Southeast Executive Forum and Awards Gala on March 15, 2016 at the Westin ...
(Date:2/12/2016)... ... ... Fisher House Foundation Chairman and CEO Kenneth Fisher joined Governor Brian Sandoval, ... Scott Bensing, and Peggy Kearns Director, VA Southern Nevada Healthcare System yesterday to dedicate ... be the first Fisher House in Nevada, and will provide free lodging for families ...
(Date:2/12/2016)... ... , ... Erlanger Agency has announced a new partnership in its ongoing community ... on the fight against breast cancer, fundraising for a local woman named Carmen, who ... Carmen is a loving single mother of two boys who also serves as caregiver ...
(Date:2/12/2016)... ... February 12, 2016 , ... For Coast Dental dentist Everet ... RDH, and dental assistant Terrell Moore shortly before 7 a.m. to volunteer at Friday’s ... professionals, donating their time and skills to help hundreds of uninsured and underinsured people ...
Breaking Medicine News(10 mins):