European Medicines Agency Recommends Tighter Ipidacrine Medicine Restrictions

EMA Recommends Ipidacrine Medicine Restrictions

The European Medicines Agency (EMA) announced the conclusion of its review of ipidacrine-containing medicines on 18 September 2026. Its Committee for Medicinal Products for Human Use (CHMP) recommended narrower authorised uses in the Article 31 referral.

The benefits continue to outweigh the risks for defined uses, but the committee found that several existing indications were poorly defined or supported by limited and outdated evidence. EMA’s September announcement stated that the opinion would be forwarded to the European Commission for a legally binding decision. The committee opinion is not itself that decision.

Which Ipidacrine Uses Would Change

The CHMP recommends retaining symptomatic treatment of acquired mononeuropathies and polyneuropathies and adjunctive symptomatic treatment of myasthenia gravis. It also supports more specific uses during recovery from certain strokes or traumatic brain injury, symptomatic treatment of mild to moderately severe Alzheimer's disease with or without vascular dementia, and symptomatic treatment of intestinal atony.

Uses for neuritis, polyneuritis, polyradiculoneuropathy, myasthenic syndrome of various causes and demyelinating diseases would be removed. The committee said the available studies were often small, lacked suitable comparators or could have been influenced by their design. In some areas, standards of care had changed.

The committee recommended that ipidacrine be prescribed only by doctors experienced in diagnosing and treating the relevant conditions. Dosing recommendations for some uses would be revised. The committee found no new safety signal, but noted an increased risk of side effects at high doses and that liver toxicity could not be excluded. It recommends caution above 80 milligrams per day and in patients with current or previous abnormal liver function.