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

Friday, Apr 11, 2014
Annals of Rheumatic Diseases, 04/11/2014 Banka S, et al. – Leri’s pleonosteosis (LP) is an autosomal dominant rheumatic condition characterised by flexion contractures of the interphalangeal joints, limited motion of multiple joints, and short broad metacarpals, metatarsals and phalanges. Scleroderma–like skin thickening can be seen in some individuals with LP. The authors...Read More
Friday, Mar 28, 2014
The Journal of Heart and Lung Transplantation, 03/28/2014 Nair N, et al. – Cancers in post–transplant patients exhibit the same molecular and cellular properties as those in their non–transplanted counterparts and arise secondary to uncontrolled/sustained growth, apoptosis resistance, inhibition of tumor suppressors, immortalization of cells with invasion, and metastasis. The...Read More
Thursday, Apr 10, 2014
European Journal of Nuclear Medicine & Molecular Imaging, 04/10/2014 Hesse S, et al. – Modulation of the immune system by the CNS may involve serotonergic regulation via the brain serotonin transporters (SERT). The objective of the study was to assess the availability of SERT in antidepressant–naive patients with MS by means of PET. Serotonergic neurotransmission in MS patients is...Read More
Friday, Apr 11, 2014
Biological Psychiatry, 04/11/2014 Hajek T, et al. – Type 2 diabetes mellitus (T2DM), but also prediabetes, may be risk factors for prefrontal neurochemical alterations in bipolar disorder (BD). These changes were associated with poor psychosocial functioning and could indicate impaired energy metabolism. The findings emphasize the importance of improving diabetes care in BD and suggest...Read More
Thursday, Apr 10, 2014
Critical Care, 04/10/2014 Ruan SY, et al. – The study aimed to explore the grounds for the inconsistent results in previous studies and update the evidence. The effects of corticosteroids on the mortality of ARDS differed by duration of outcome measures and etiologies. Corticosteroids did not improve longer–term outcomes and may cause harm in certain subgroups. Current data do not...Read More