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 QT interval prolongation prior to starting Gilenya or at any time during the cardiovascular monitoring period after they take the first dose.
  • Who are taking other drugs that prolong the QT interval and that can cause a serious and life-threatening abnormal heart rhythm called Torsades de pointes.

Patients taking Gilenya should seek immediate medical care if they develop dizziness, tiredness, irregular heartbeat or palpitations -- signs of a slowing heart rate, the FDA said. Patients should not stop taking Gilenya without talking to their doctor.

Gilenya is prescribed to prevent MS flare-ups and slow progression of the nervous system disorder.

More information

The National Multiple Sclerosis Society has more about MS treatments.

-- Robert Preidt

SOURCE: U.S. Food and Drug Administration, news release, May 14, 2012


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

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:7/2/2020)... ... July 02, 2020 , ... Allegheny Health Network (AHN) today ... Medical Information Officer (CMIO), effective immediately. Dr. Lee succeeds Robert White, MD, who ... through the end of the year to help support a seamless transition. , Dr. ...
(Date:7/1/2020)... , ... July 01, 2020 , ... ... Doug Salvador, MD, Associate Professor of Medicine at the University of Massachusetts Medical ... Safety Strategies, LLC have joined the SIDM Board of Directors. Dr. Salvador and ...
(Date:6/28/2020)... ... June 26, 2020 , ... Recovery from drug and ... addiction treatment center, proudly announces that it has reopened to serve new clients ... in a world affected by Covid-19. , When social-distancing guidelines changed the way ...
(Date:6/25/2020)... ... June 25, 2020 , ... Pivot ... KLAS Overall IT Services Firm, expanded its telehealth services to provide ... seasoned telehealth expert and a Consulting Magazine “2020 Women Leaders in Technology” award ...
(Date:6/24/2020)... ALPHARETTA, Ga. (PRWEB) , ... June 24, 2020 ... ... analytics and population health management, today announced that Wexford Physician Hospital Organization (PHO) ... its quality and cost goals within the framework of value-based care. Use of ...
Breaking Medicine News(10 mins):
(Date:6/19/2020)... ... 2020 , ... Evalueserve, a leading global analytics firm, has ... combines three sub-indices that COVID-19 has had the strongest impact on: healthcare, economic/work ... looking at these three areas at once –something that has been absent until ...
(Date:6/19/2020)... NEW YORK (PRWEB) , ... June 19, 2020 , ... ... PODD newsletter builds on the success of the company’s PODD: Partnership Opportunities in Drug ... meetings. , The newsletter is dedicated to highlighting different voices making an impact ...
(Date:6/19/2020)... ... ... A May 31 article on Yahoo Finance reports on a ... their health and begin to start scheduling in-person visits when needed now that protocols ... in Southern California never reached full capacity or experienced the surge in COVID-19 patients ...
Breaking Medicine Technology: