Epilepsy Drug Zonegran Linked to Blood Imbalance, Heart Problems

Zonegran, an anti-seizure pill used to treat epilepsy in adults, can cause dangerous chemical dangerous imbalances in the blood and result in life-threatening heart problems, among other serious problems, the Food and Drug Administration said.

Recent FDA data shows that Zonegran can cause metabolic acidosis, a condition which involves high acid levels in the blood and has been linked to an increased risk of heart attacks, hyperventilation, irregular heart rhythms, fatigue, and difficulty breathing.

If not detected and treated properly, metabolic acidosis can also result in permanent damage to the kidneys and bones and slow growth in children, according to the FDA.

Zonegran is made by Eisai Inc. of Woodcliff, N.J. and is available in generic form as zonisamide from manufacturers including Teva Pharmaceutical Industries Ltd., Mylan Inc., Novartis AG’s Sandoz unit, and Watson Pharmaceuticals Inc.

New Warning Labels Ordered

Federal drug-safety officials are advising physicians to monitor blood serum levels in Zonegram patients even if symptoms of increased blood acid levels are not present. Changes to the labeling of Zonegram are also in the works, with stronger new warnings to be added about the risks of high blood acid levels, the FDA said.

Other Risks of Zonegran Use

The FDA said studies have found that patients taking higher doses of the drug were more likely to develop metabolism problems. However, lower doses of Zonegran did not produce the same complications. Patients with kidney disease, diarrhea, and breathing problems are more likely to suffer complications caused by acid imbalances.

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