(RxWiki News) The FDA gave new warnings for Ampyra. Some people taking this drug for Multiple Sclerosis may be at risk of having seizures in the first few days or weeks of taking the drug.
Patients taking Ampyra should talk to their doctors about any kidney problems or any history of seizures.
Doctors should be doing blood tests to watch kidney function while you are taking the drug.
"Talk to your doctor about your risk of seizure."
Ampyra (dalfampridine) was approved by the Food and Drug Administration (FDA) in 2010 to improve walking for people with Multiple Sclerosis.
The FDA looked over information they have been getting about seizures. On July 23 they issued an update to the warning label information.
The new label warns that people taking the drug may be at risk for seizures, especially during the first few days or weeks they are taking the drug.
It also warns that anyone with kidney problems is at higher risk for seizures.
Ampyra is processed by the kidneys, so any problems with kidney function can raise the levels of the drug in the blood. If the kidneys are not working properly, the drug cannot be cleared from the blood.
The FDA gave the following guidelines for patients taking Ampyra:
• Do not double-up on doses of Ampyra. If a dose is missed, talk to your doctor.
• Do not crush or chew Ampyra tablets or capsules.
• Tell your doctor about any history of kidney problems.
• Tell your doctor if you have ever had a seizure.
• Make sure your doctor is doing blood tests to watch your kidney function.
The new safety alert urged doctors to monitor kidney function while their patients are taking Ampyra. Blood tests at least once a year should be done to check for kidney problems.
Anyone with a history of seizures should not take Ampyra.
The FDA issued this new safety warning as part of their Safety and Adverse Event monitoring program.