Safety Alerts & Recalls

What does this mean?

For most patients, the benefits of zonisamide (Zonegran) will outweigh the risk of metabolic acidosis. If you take zonisamide (Zonegran), you should speak to your physician about your risk for metabolic acidosis at your next appointment. This is particularly important if you have a condition that puts you at a higher risk for metabolic acidosis, such as kidney problems, severe lung problems, diarrhea, or if you are planning to have surgery. If you notice any unexplained difficulty breathing, fatigue, loss of appetite, or confusion, please follow up with your doctor as soon as possible.

New Safety Warning for Zonisamide/Zonegran

The FDA has announced that zonisamide (Zonegran), a treatment for seizures, can cause metabolic acidosis and is recommending that all patients taking zonisamide (Zonegran) receive periodic blood work to monitor for this condition. Metabolic acidosis is a rare, but serious condition that causes increased acidity of the blood and can result in difficulty breathing and other symptoms such as fatigue, loss of appetite, or confusion. Long-term metabolic acidosis may cause problems with the kidneys and bones.

Patients with certain conditions such as kidney problems, severe lung problems, diarrhea, surgery, ketogenic diet, or certain other drugs may be at greater risk for developing metabolic acidosis following treatment with zonisamide. The risk of zonisamide-induced metabolic acidosis appears to be more common and severe in younger patients.

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Source: FDA
Publication Date: 2009-02-24
Last Updated: 2009-12-05

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