Navigation Links
FDA Issues Multiple Sclerosis Drug Alert

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:
Related Image:
FDA Issues Multiple Sclerosis Drug Alert
(Date:12/1/2015)... ... 01, 2015 , ... PYA’s latest white paper, “ PYA ... main “pain point” for merging or aligning healthcare provider organizations—when mergers and other ... This quick-read guidance suggests that failing to recognize the power of an ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... and SACC-USA through membership and leadership since 2008. Gary Bruce, President of ... SACC-USA . Gary has spent a significant amount of time in Sweden since ...
(Date:12/1/2015)... ... , ... Nurotron Biotechnology Co., Ltd., maker of cochlear implant systems, has won ... order will be from the China Disabled Persons’ Federation, a central government association, for ... for children and adults suffering from severe and profound hearing loss . The ...
(Date:12/1/2015)... , ... December 01, 2015 , ... ... on receiving the 2015 HSJ Acute Sector Innovation Award on November 18th. This ... patient care experience, and propose exciting enhancements to the medical landscape. , The ...
(Date:11/30/2015)... ... 2015 , ... Third Molar SEO , one of ... launched a sleek, mobile-ready and user-centric redesigned website. , Vivek Srivastava, founder and ... the benefits that its SEO services provide to dentists and why Third Molar ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... , Nov. 30, 2015  The ... norm in U.S. medical imaging is on ... popular accountable care payer-provider contracts are set ... in their wake, alter provider-vendor relationships. The ... will push forward new purchasing frameworks in ...
(Date:11/30/2015)... , Nov. 30, 2015 Oramed Pharmaceuticals Inc. ... on the development of oral drug delivery systems, announced ... valued at up to $50,000,000 with Hefei Tianhui Incubator of Technologies Co., ... insulin capsule, ORMD-0801, in China , ... Macau . The agreements were signed at the ...
(Date:11/30/2015)... Nov. 30, 2015 iCAD, Inc. (Nasdaq: ... feature its latest solutions for advanced image analysis ... cancer at the Radiological Society of North American ... from November 29 to December 4, ... including iReveal®, an automated breast density assessment solution, ...
Breaking Medicine Technology: