Keep up to date on the latest medical news at MDLinx - FREE!


  • Stay current on the latest medical literature, research and clinical news
  • MD jobs and physician job search at our new medical job Career Center
  • Receive invitations to paid market research
  • Search Clinical Trials and Medical Conferences

register to view free medical at articles at MDLinx

Follow Us

Posts by category

MDLinx Blog - Medical News and more.

Current Articles | RSS Feed RSS Feed

FDA: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)

  
  
  
  
  

FDA issues drug safety annoucement for multiple sclerosis drug Gilenya (fingolimod).

The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod). The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes. FDA could not definitively conclude that Gilenya was related to any of the deaths (see Data Summary, below). However, based on its reevaluation of the data, FDA remains concerned about the cardiovascular effects of Gilenya after the first dose. Data show that, although the maximum heart rate lowering effect of Gilenya usually occurs within 6 hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose in some patients (See Data Summary).

For this reason, Gilenya is now contraindicated (FDA advises against its use) in patients with certain pre-existing or recent (within last 6 months) heart conditions or stroke, or who are taking certain antiarrhythmic medications. See CONTRAINDICATION section of the drug label2.

FDA continues to recommend that all patients starting Gilenya be monitored for signs of a slow heart rate (bradycardia) for at least 6 hours after the first dose. FDA is now recommending hourly pulse and blood pressure measurement for all patients starting Gilenya. Electrocardiogram (ECG or EKG) testing should be performed prior to dosing and at the end of the observation period. Cardiovascular monitoring should continue until any symptoms resolve.

Read full release here.

All Posts

Trending Medical Articles

Tuesday, Apr 8, 2014
International Journal of Cardiology, 04/08/2014 Tang E, et al. – AMS is a disease that occurs when accessing high altitude (HA) or upon exposure to a higher altitude after acclimatising over 3000m. Evidence shows that drugs can prevent AMS. The function of dexamethasone for preventing AMS is important. No systematic review has previously been published about the effect of dexamethasone....Read More
Tuesday, Mar 25, 2014
Indian Journal of Surgery, 03/25/2014 Liu J, et al. – Current techniques to reconstruct soft tissue of the fingers result in scarring and functional deficits. Perforator flaps raised on the posterior interosseous artery are thin and well vascularised, and cause minimal donor site scarring. The authors used modified innervated posterior interosseous perforator flaps to repair digital...Read More
Tuesday, Apr 1, 2014
Transplantation Proceedings, 04/01/2014 Hatakeyama S, et al. – The development of immunosuppressive techniques has helped overcome the ABO incompatibility barrier. However, the outcomes of ABO–incompatible (ABOi) kidney transplantation remain a controversial issue with the advent of the anti–CD20 chimeric antibody rituximab. These results suggest that the outcomes of ABOi...Read More
Tuesday, Apr 8, 2014
Epilepsy & Behavior, 04/08/2014 Peterson CL, et al. – The study aims to examine key determinants of anxiety and depression in a community sample of people with epilepsy. Understanding the mechanisms involved in anxiety and depression in a community sample of people with epilepsy requires the inclusion of opportunities for paid employment and the effects of psychosocial factors such as...Read More
Monday, Mar 24, 2014
Practical Diabetes, 03/24/2014 Raghavan RP, et al. – With the increasing emphasis on consultant delivered health care outside normal working hours, these researchers introduced structured seven–day working for consultants on a 28 bedded diabetes base ward and found that it is effective in facilitating increased discharges with reductions in length of stay (LoS) and readmissions,...Read More