FDA cites acid imbalance with epilepsy drug
WASHINGTON – Federal health officials warned doctors Monday that a
drug used in epilepsy patients can cause chemical imbalances in the
blood, leading to heart problems and other serious complications.
The Food and Drug Administration said recent data show patients taking
the antiseizure pill Zonegran face higher risk of metabolic acidosis,
which causes dangerously high levels of acid to accumulate in the
blood. The imbalance can cause breathing difficulties, irregular heart
rhythms and fatigue.
Left untreated, the condition can do long-term damage to the kidneys
and bones and slow growth in children.
FDA advised physicians to monitor patient's blood serum levels while
they are taking Zonegran, even if they don't have symptoms. The agency
said it will work with drugmakers to add new warning information
labels to the drug.
Zonegran is sold by Woodcliff, N.J.-based Eisai Inc.
"We've been in discussions with FDA regarding the issue and have
submitted a proposed label change for the agency to review and
approve," said company spokeswoman Judee Shuler.
The drug is also available under its generic name zonisamide from
various manufacturers.
Data reviewed by the FDA showed patients taking higher doses of the
drug were more likely to develop metabolism problems, though they were
also seen at low doses. Patients with kidney disease, diarrhea and
breathing problems are predisposed to suffer acid imbalances.
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