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Clinical Psychiatry News - Drug combination for migraines deemed too risky for approval.(Pain Medicine)

ROCKVILLE, MD. — At a meeting last month, members of the Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee agreed that the risk of tardive dyskinesia associated with the metoclopramide component of a fixed-dose combination pill outweighed the product’s benefits for treating migraines.

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All 12 panel members found that there was not enough evidence to assume that the intermittent chronic use of the product, which combines metoclopramide with naproxen, did not cause tardive dyskinesia (TD) and that it was not possible to determine a maximum …

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