Death of MS patient prompts FDA Gilenya review

Gilenya, or Fingolimod, is the first approved oral disease modifying drug for MS.

Death of MS patient prompts FDA Gilenya review

Postby MSUK » Thu Dec 22, 2011 2:02 am

Image

The death of a multiple sclerosis patient shortly after a first dose of fingolimod (Gilenya) is under review by the FDA, the agency said.

No specific cause of death has been determined in the case, which occurred on Nov. 23, and the FDA emphasized that it had not ascertained that the drug was related to the fatal outcome.

Fingolimod's prescribing information includes a warning about bradycardia and/or atrioventricular conduction block in the first hours after starting the drug. Clinicians are advised to monitor patients for six hours following the first dose.

In the fatal case, the patient was also taking the beta-blocker metoprolol and the calcium channel antagonist amlodipine. These drugs are associated with increased risk for bradycardia and heart blocks, the FDA noted.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1309
MS-UK - http://www.ms-uk.org/
User avatar
MSUK
Family Elder
 
Posts: 2092
Joined: Wed Oct 14, 2009 3:00 pm

Advertisement

Re: Death of MS patient prompts FDA Gilenya review

Postby CureOrBust » Thu Dec 22, 2011 5:38 am

No specific cause of death has been determined in the case, which occurred on Nov. 23, and the FDA emphasized that it had not ascertained that the drug was related to the fatal outcome.
Really? I find it hard to believe that this is the first case of someone who is taking Gilenya to have died, its only the first within 24hrs? The only reason this case is being reported is because there is some known link to the medication. I also find it hard to believe that no autopsy has been completed with a cause of death. I am not normally one for conspiracy theories, but I am thinking Novartis are blocking the release of this information somehow.
User avatar
CureOrBust
Family Elder
 
Posts: 2883
Joined: Wed Jul 27, 2005 3:00 pm
Location: Sydney, Australia


Return to Gilenya

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users