FDA MedWatch - Ampyra (dalfampridine): Drug Safety Communication - Seizure Risk for Multiple Sclerosis Patients

[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]

 



Title: FDA MedWatch - Ampyra (dalfampridine): Drug Safety Communication - Seizure Risk for Multiple Sclerosis Patients
MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

Drug Safety Communication - Seizure Risk for Multiple Sclerosis Patients

AUDIENCE: Neurology, Internal Medicine

ISSUE: FDA is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine). Using information received from post-market adverse event reports, FDA recently evaluated seizure risk in MS patients taking Ampyra (dalfampridine).  The majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures. The FDA is updating the Ampyra drug label to clarify recommendations.

BACKGROUND: Ampyra was approved to improve walking in patients with MS. Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug.  Ampyra is eliminated from the body through the kidneys, and patients with kidney impairment may develop higher blood levels of the drug, thereby increasing their seizure risk.  

RECOMMENDATION: FDA reminds health care professionals that there are age-related decreases in renal function, and mild renal impairment is common after age 50, even when serum creatinine is normal.  Renal function should be assessed by estimating creatinine clearance. Ampyra should not be used in patients with a history of seizures or who have moderate to severe renal (kidney) impairment (measured as creatinine clearance [CrCl] less than or equal to 50 mL/min).

Additional information for Patients includes:

Additional information for Health Care Professionals includes:

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch

Safety Information and Adverse Event Reporting Program:

Read the MedWatch safety alert, including links to the Drug Safety Communication at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm313055.htm

 

 


This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery

[Index of Archives]     [CDC News]     [NIH News]     [USDA News]     [Steve's Art]     [Camping in Yosemite]     [PhotoForum]     [SB Lupus]     [STB]

  Powered by Linux