FDA Warns of Seizure Risk with Ampyra
On July 23, 2012, the Food and Drug Administration (FDA) issued a statement warning patients taking the multiple sclerosis (MS) drug Ampyra about an increased risk of seizures associated with medication.
“Ampyra can cause seizures, even if you have never had a seizure before,” FDA Safety Communication.
Details about the Ampyra Warning
The FDA conducted an evaluation of MS patients taking Ampyra and found that patients with no history of seizures were having seizures within days or weeks of starting the recommended dose of the drug. Although seizures are a known side effect of Ampyra, the risk increases with higher blood levels, which can be caused by Ampyra when it is eliminated through the kidneys.
For this reason, the FDA recommends that all patients have their kidney function tested before taking Ampyra and receive annual kidney function tests while on the drug. Additionally, the FDA discourages patients who miss a dose from taking an extra dose at a later time because the extra dose may severely increase the risk of seizures.
Facts about Ampyra
Information below provided by the FDA
- Ampyra was designed to improve walking in patients with multiple sclerosis.
- It was developed and manufactured by Acorda Therapeutics Inc. and was approved by the FDA in 2010.
- Between March 2010 and March 2011 approximately 46,000 patients received prescriptions for Ampyra.
- The maximum recommended dose of Ampyra is 10 mg twice daily (taken 12 hours apart).
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