NEWS - FDA cites acid imbalance with epilepsy drug

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FDA cites acid imbalance with epilepsy drug

WASHINGTON (AP) — 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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