Ampyra (dalfampridine) Update on Seizure Risk in Patients with Multiple Sclerosis

FDA updates neurology, internal medicine healthcare professionals and the public of the seizure risk in patients with multiple sclerosis starting Ampyra (dalfampridine). The drug label is updated to clarify recommendations.

Background of Ampyra (dalfampridine)

Ampyra (dalfampridine), by Acorda, is approved to be used for the improvement of walking in patients with multiple sclerosis. Higher blood levels of Ampyra increase seizure risk which is a known side effect of the drug.

FDA Alert on Ampyra (dalfampridine)

Post-market adverse events report information was evaluated by the FDA concerning the seizure risk in patients taking Ampyra (dalfampridine). Patients with kidney (renal) impairment may develop higher blood levels of the drug increasing the risk of seizure because the drug is eliminated from the body through the kidneys.

FDA Recommendation on Ampyra (dalfampridine)

“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:

• Tell your health care professional if you have kidney problems.
• Your health care professional should order blood tests periodically to evaluate your kidney function.
• Do not take Ampyra if you have ever had a seizure.
• Ampyra tablets should be taken whole and not divided, crushed, chewed, or dissolved.
• Do not take double or extra doses of Ampyra if a dose is missed.  Side effects, including seizures, are more frequent at higher doses.

Additional information for Health Care Professionals includes:

• Ampyra is contraindicated in patients with a history of seizures or with moderate to severe renal impairment (CrCl < 50 mL/min).
• The potential benefits of Ampyra treatment should be carefully considered against the risk of seizures before using Ampyra in patients with mild renal impairment (CrCl 51-80 mL/min).
• A patient’s CrCl (calculated using the Cockroft-Gault equation) should be known before initiating Ampyra treatment and monitored at least annually whileAmpyra treatment continues, even when serum creatinine levels appear to be normal.
• Tell patients they should not take double or extra doses of Ampyra if a dose is missed.  Adverse effects, including seizures, are more frequent at higherdoses.
• Ampyra should be discontinued permanently if a seizure occurs.”

Contacting the FDA to report cases with Ampyra (dalfampridine)

In case of detection of adverse events or side effects related to the use of Ampyra (dalfampridine), healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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