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, an
'/>"/>

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

Page: 1 2 3

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:3/2/2015)... THE WOODLANDS, Texas , March 2, 2015 /PRNewswire/ ... ), a biopharmaceutical company focused on developing breakthrough treatments ... year end 2014 financial results on Wednesday, March 4, ... hold a conference call and webcast to discuss clinical ... and year end of 2014 at 10:00 a.m. Eastern ...
(Date:3/2/2015)... LOS ANGELES , March 2, 2015 ImmunoCellular Therapeutics, ... report financial results for the year ended December 31, 2014 on ... update conference call and webcast on Thursday, March 12, 2015, at ... Gengos , President and CEO.   , ... international dial-in: (631) 291-4544; conference code 92238648. , , , ...
(Date:3/1/2015)... , March 1, 2015 /CNW Telbec/ -   Ergoresearch ... Laval and known under the « Équilibre, ... for the second quarter Ended on December 31, 2014. ... Canadian currency. Revenues for the second ... 31, 2014 totaled $ 4 095 112 decreasing by 8,8 % compared ...
Breaking Medicine Technology:Lexicon To Report Fourth Quarter And Year End 2014 Financial Results On March 4, 2015 2ImmunoCellular Therapeutics to Report 2014 Financial Results on March 9, 2015; a Business Update Conference Call and Webcast is Scheduled for March 12, 2015 2Second Quarter results - Fiscal 2015 - Ergoresearch reports its results for the quarter ended December 31, 2014. 2Second Quarter results - Fiscal 2015 - Ergoresearch reports its results for the quarter ended December 31, 2014. 3Second Quarter results - Fiscal 2015 - Ergoresearch reports its results for the quarter ended December 31, 2014. 4
(Date:3/2/2015)... March 02, 2015 Robins & Morton ... conjunction with Women in Construction Week (March 1-7, sponsored ... NAWIC) and National Women’s History Month, Robins & Morton ... affect the company and the construction industry as a ... to the dozens of roles in between, each woman ...
(Date:3/2/2015)... The Workgroup for Electronic Data Interchange (WEDI), ... health IT to create efficiencies in healthcare information exchange, ... Providers.” The white paper by WEDI’s ICD-10 Testing Subworkgroup ... testing by focusing on primary considerations and steps for ... October 1, 2015 implementation date. Download the white ...
(Date:3/2/2015)... This year, the National Multiple Sclerosis Society’s annual ... for people across the country to unite, raise awareness, ... live their best lives. MS Awareness Week is a special ... join the Society’s vision of a world free of MS. ... of the central nervous system, interrupts the flow of information ...
(Date:3/2/2015)... March 02, 2015 Four Seasons Resort Maui ... its 25th anniversary this year, having officially opened its doors ... luxury resort is honoring over 70 employees who started on ... from amongst the approximately 400 original employees. The celebration ... Oceanfront Lawn. , This Four Seasons flagship resort, ...
(Date:3/2/2015)... March 02, 2015 What are the ... physicians request references? When are interviews scheduled, how can ... opportunities?, Both training and practicing physicians who are looking ... questions and more at the PracticeLink Physician Career Advancement ... drop-in Job Fair is from 5:30 to 8:30 p.m. ...
Breaking Medicine News(10 mins):Health News:Robins & Morton Recognizes Women In Construction 2Health News:WEDI Releases New White Paper on ICD-10 Testing for Small Providers 2Health News:Every Connection Counts During MS Awareness Week 2Health News:Every Connection Counts During MS Awareness Week 3Health News:Every Connection Counts During MS Awareness Week 4Health News:Celebrating Four Seasons Resort Maui’s 25th Anniversary 2Health News:PracticeLink to Host a Career Advancement Workshop and Job Fair in Houston 2
... , , Hospitals, ... , PRINCETON, N.J., Aug. 18 Twelve New ... federal government to test an innovative new incentive method that aims ... , The three-year trial program could serve as a ...
... KONG, Aug. 18 IBM (NYSE: IB M ... Life Insurance Company Limited (NYSE: CI ), has implemented ... continuity in the event of disasters or other incidents that could ... (Logo: http://www.newscom.com/cgi-bin/prnh/20090416/ I BMLOGO ) ...
... 18 EwingCole, a nationally recognized architectural, engineering, interior ... today announced that it will combine its practice with ... with a robust portfolio of healthcare projects. The ... September 1, 2009, will create the Delaware Valley,s largest ...
... , , ... systems for targeted, less-invasive medical treatments, today announced that Massachusetts ... iCT, making it second in the nation and third in ... successfully integrate intra-operative imaging -- from high-field MRI to multi-slice ...
... , ARLINGTON, Va., Aug. 18 "Proposed ... add billions of dollars of un-reimbursed cost to the Medicare ... K.C. McAlpin, executive director of ProEnglish, a national organization that ... the United States. , , The ...
... ELM GROVE, Wis., Aug. 18 Long wait times can ... safety . Many hospitals constantly struggle with moving patients in need of critical ... bed. Compirion Healthcare Soluti o ns is ... Improving Patient Flow - ED to Inpatient , free of charge ...
Cached Medicine News:Health News:Medicare Picks N.J. to Test Innovative Incentive System 2Health News:Medicare Picks N.J. to Test Innovative Incentive System 3Health News:Medicare Picks N.J. to Test Innovative Incentive System 4Health News:CIGNA Provides Peace-of-mind for APAC Customers by Ensuring Business Continuity and Resilience with IBM 2Health News:CIGNA Provides Peace-of-mind for APAC Customers by Ensuring Business Continuity and Resilience with IBM 3Health News:CIGNA Provides Peace-of-mind for APAC Customers by Ensuring Business Continuity and Resilience with IBM 4Health News:EwingCole, RDLA Join Together, Creating Architecture/Engineering Firm With Largest Healthcare Focus in the Delaware Valley 2Health News:EwingCole, RDLA Join Together, Creating Architecture/Engineering Firm With Largest Healthcare Focus in the Delaware Valley 3Health News:Massachusetts General Hospital is Second in Nation to Acquire Both BrainSUITE(R) iMRI and iCT 2Health News:Free Compirion Bed Flow Webinar Helps Improve Patient Flow From ED to Inpatient Units 2Health News:Free Compirion Bed Flow Webinar Helps Improve Patient Flow From ED to Inpatient Units 3
For the quantitative determination of Creatine Kinase in serum....
For the quantitative determination of creatine kinase in serum. Kinetic Reaction measured at 340 nm. Linearity: 1500 IU/L at 37C....
For the quantitative determination of total glucose in serum....
Intended for the quantitative determination of glucose in serum. Reaction: endpoint. Wavelength: 500 nm. Linearity: 500 mg/dL (27.8 mmol/L)....
Medicine Products: