Navigation Links
FDA Issues Multiple Sclerosis Drug Alert
Date:5/14/2012

MONDAY, May 14 (HealthDay News) -- The multiple sclerosis drug Gilenya (fingolimod) should not be given to patients with certain pre-existing or recent heart conditions or stroke, or those taking certain medications to correct heart rhythm problems, says a U.S. Food and Drug Administration safety announcement issued Monday.

The warning follows the FDA's evaluation of a report of a patient who died within 24 hours after receiving the first dose of Gilenya. The agency also reviewed additional clinical trial and post-approval data for the drug, including reports of patients who died of cardiovascular or unknown causes.

While it couldn't definitively conclude that Gilenya was related to any of the deaths, the FDA said it has concerns about the cardiovascular effects of the drug after the first dose. The data analysis showed that even though the maximum heart rate-lowering effect of the drug usually occurs within six hours of taking the first dose, this effect can occur as late as 20 hours after the first dose.

Along with the other recommendations, the FDA said that all patients starting Gilenya should be monitored for signs of a slow heart rate for at least six hours after the first dose and have hourly pulse and blood pressure measurements.

Patients should undergo electrocardiogram testing before receiving the drug and at the end of the observation period. In addition, extended cardiovascular monitoring should continue overnight in patients who are at higher risk for, or who may not tolerate, a slow heart rate (bradycardia).

These high-risk patients include those:

  • Who develop severe bradycardia after receiving the first dose of Gilenya.
  • With certain pre-existing conditions in whom bradycardia may be poorly tolerated.
  • Receiving therapy with other drugs that slow the heart rate or electrical impulses that regulate the heartbeat.
  • Who have a heart rhythm abnormality called
    '/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Page: 1 2

Related medicine news :

1. Genetic abnormalities in benign or malignant tissues predict relapse of prostate cancer
2. Radiologists rank themselves as less than competent on health policy issues
3. UCSF chancellor issues call-to-arms to patient advocates
4. Snoring Tots May Develop Behavioral Issues Later
5. U.S. Soldiers Face Host of Mental Health Issues
6. Younger breast cancer patients have more adverse quality-of-life issues
7. ATS issues joint statement on key issues and recommendations for critical care research
8. CDC Issues New TB Treatment Guidelines
9. American Society of Clinical Oncology issues annual report on progress against cancer
10. AAOS issues new clinical practice guideline for treating common elbow fractures in children
11. Experts Design Toolkit to Help Spot Teens With Mental Health Issues
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Issues Multiple Sclerosis Drug Alert
(Date:8/2/2014)... On July 21, 2014, the Johns Hopkins Health System ... the class action lawsuit filed October 24, 2013, ... MM, on behalf of thousands of women who allegedly were ... According to The Baltimore Sun , the $190 million ... physician accused of sexual misconduct. , An investigation prompted by ...
(Date:8/1/2014)... August 02, 2014 Although most people ... their teeth and gums, it is particularly important for ... gum disease in two different ways. Hormones can affect ... difficult for these tissues to receive nutrients essential to ... the body responds to toxins produced by plaque bacteria, ...
(Date:8/1/2014)... The Judicial Panel on Multidistrict Litigation (JPML) ... caused strokes, heart attacks, and other injuries in men ... Kennelly as the transferee judge and ordered what could ... court. , As one of his first organizing acts, ... attorneys who will move the litigation forward on behalf ...
(Date:8/1/2014)... (PRWEB) August 01, 2014 Parker Waichman ... rights of victims injured by defective medical devices and ... be recalling its Ethicon surgical power morcellator devices used ... sited concerns involving the spread of cancer associated with ... dated July 31, 2014. , Johnson & Johnson ...
(Date:8/1/2014)... Almost 140 people die every year in accidents ... But there are several simple ways to ... coordinator at Cincinnati Children,s Hospital Medical Center,s Comprehensive ... news release. "As families begin to prepare ... parents and children to go over school bus ...
Breaking Medicine News(10 mins):Health News:Baltimore Lawyer Steven H. Heisler Urges Victims of OB/GYN Misconduct to Speak Out 2Health News:Baltimore Lawyer Steven H. Heisler Urges Victims of OB/GYN Misconduct to Speak Out 3Health News:Midtown Dentistry Renews Call for Women to Look After Their Dental Health 2Health News:Judge Kennelly Appoints Attorney Michelle Kranz to the Plaintiffs’ Executive Committee in the Testosterone Replacement Therapy MDL 2Health News:J&J's Ethicon Unit Recalls its Power Morcellator Devices After Warnings by Federal Regulators and Concern About Risk of Spreading Occult Cancer, Parker Waichman Comments 2Health News:J&J's Ethicon Unit Recalls its Power Morcellator Devices After Warnings by Federal Regulators and Concern About Risk of Spreading Occult Cancer, Parker Waichman Comments 3Health News:J&J's Ethicon Unit Recalls its Power Morcellator Devices After Warnings by Federal Regulators and Concern About Risk of Spreading Occult Cancer, Parker Waichman Comments 4Health News:Expert Offers School Bus Safety Tips 2
... had been in the forefront, monitoring the Herculean task of ... the documentation of the dealers. // This is being done ... is still in safe custody. 20 teams comprising of officials ... with local civic officials. ,The teams will be ...
... in Hong Kong and China have identified the deadly H5N1 ... markets of Southern China, sparking fears of bird flu pandemic//. ... hosts of the bird flu virus. This however is the ... detected among seemingly healthy chickens. Infected chickens usually die within ...
... 'in'? A new report by the American Medical Association has ... wild (s) ways!// ,A survey of 644 female college ... berserk is their take on having fun in life. Three out ... for outrageous behavior- spring break drinking meant bingeing on booze, getting ...
... for a probable influenza pandemic, and its effects on 2.6 ... concern and at a press conference , Health Minister Philippe// ... the beginning of the epidemic we're able to limit the ... plan ready, to face a worst-case possibility, of the initial ...
... It's been a long haul from a medical college here ... becoming the only Indian-born radiologist// licensed to privately practise in ... in his specialty along the way., ,He sees up ... p.m. and then writes up the reports, a task that ...
... means just tough whole-grain products. The movement has burst out ... are available that would have been unthinkable a few years ... whole-grain muesli, rubbery tofu and tasteless vegetarian cutlets, but times ... of Europe today, you will find organic ice cream and ...
Cached Medicine News:Health News:Healthy, Bird Flu Infected Chickens In Chinese Markets 2Health News:Indian-Born Doctor Diddy Shines In Germany 2Health News:Organic food loses its whole-grain image 2
(Date:7/31/2014)... July 31, 2014 Tandem Diabetes Care®, Inc. (NASDAQ: ... of the t:slim® Insulin Pump, today reported its financial results ... In comparing the second quarter of 2014 to the same ... $10.3 million from $5.5 million , t:slim Pump shipments ... In comparing six months ended June 30, 2014 to ...
(Date:7/31/2014)... SUNNYVALE, Calif., July 31, 2014 Pharmacyclics, Inc. (the ... and recent developments for the quarter ended June 30, 2014. ... Ended June 30, 2014 Revenue Total revenue for the ... $54.7 million for the quarter ended June 30, 2013 primarily ... $109.5 million. Total revenue for the six ...
(Date:7/31/2014)... SAN FRANCISCO, July 31, 2014 Nektar Therapeutics (Nasdaq: ... the second quarter ended June 30, 2014. ... were $301.4 million as compared to $309.1 million at March ... time for Nektar as we look forward to significant milestones ... W. Robin, President and Chief Executive Officer of Nektar. "The ...
Breaking Medicine Technology:Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 2Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 3Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 4Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 5Tandem Diabetes Care Reports Second Quarter 2014 Financial Results 6Pharmacyclics Reports Second Quarter 2014 Results 2Pharmacyclics Reports Second Quarter 2014 Results 3Pharmacyclics Reports Second Quarter 2014 Results 4Pharmacyclics Reports Second Quarter 2014 Results 5Pharmacyclics Reports Second Quarter 2014 Results 6Pharmacyclics Reports Second Quarter 2014 Results 7Pharmacyclics Reports Second Quarter 2014 Results 8Pharmacyclics Reports Second Quarter 2014 Results 9Pharmacyclics Reports Second Quarter 2014 Results 10Pharmacyclics Reports Second Quarter 2014 Results 11Pharmacyclics Reports Second Quarter 2014 Results 12Pharmacyclics Reports Second Quarter 2014 Results 13Pharmacyclics Reports Second Quarter 2014 Results 14Pharmacyclics Reports Second Quarter 2014 Results 15Pharmacyclics Reports Second Quarter 2014 Results 16Pharmacyclics Reports Second Quarter 2014 Results 17Pharmacyclics Reports Second Quarter 2014 Results 18Pharmacyclics Reports Second Quarter 2014 Results 19Pharmacyclics Reports Second Quarter 2014 Results 20Pharmacyclics Reports Second Quarter 2014 Results 21Pharmacyclics Reports Second Quarter 2014 Results 22Pharmacyclics Reports Second Quarter 2014 Results 23Pharmacyclics Reports Second Quarter 2014 Results 24Pharmacyclics Reports Second Quarter 2014 Results 25Pharmacyclics Reports Second Quarter 2014 Results 26Pharmacyclics Reports Second Quarter 2014 Results 27Pharmacyclics Reports Second Quarter 2014 Results 28Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 2Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 3Nektar Therapeutics Reports Financial Results for the Second Quarter of 2014 4
... ANDOVER, Mass., June 23, 2011 Smith & Nephew, Inc., ... SNN ) (London Stock Exchange: SN) announced today ... found in Smith & Nephew,s favor that Arthrex, Inc., (Naples, ... exclusively licensed to Smith & Nephew. The ...
... Mr. Ronald L. Chez, a private investor, filed an amended ... RGEN ) with the SEC. RepliGen Corporation ... integrated company by developing and marketing innovative drugs that deliver ... and gastroenterology.  RepliGen has a core competency in the development ...
Cached Medicine Technology:Smith & Nephew Endoscopy Awarded $85 Million in Patent Infringement Case Against Arthrex, Inc. 2Smith & Nephew Endoscopy Awarded $85 Million in Patent Infringement Case Against Arthrex, Inc. 3
Lacrimal Cannulas, 19 g. shaft tapering to 23 g. curved cannula. Overall length 37.7 mm. 5/box....
Anterior Chamber Needle, 27 g. Angled. 5 mm angled tip. Overall length 20 mm. 5/box....
Anterior Chamber Needle, 20 g. Angled. 7 mm angled tip. Overall length 23 mm. 5/box....
Retinal Hydrodissection Cannula. 20 gauge shaft tapers to 41 gauge I.D. flexible tip. Packaged sterile. 5/Box....
Medicine Products: