Oral medicines containing almitrine, once a go-to therapy for chronic respiratory failure in several European countries, will be withdrawn there because the drug's benefits no longer outweigh the risk for long-lasting peripheral neuropathy and significant weight loss, European Union (EU) drug regulators announced.

 

Almitrine (Vectarion, Armanor, Servier), a respiratory stimulant, had been approved to treat chronic respiratory failure associated with chronic obstructive pulmonary disease (COPD) in France, Portugal, and Poland. It has not been approved by the US Food and Drug Administration (FDA) in the United States.

 

The European Medicines Agency (EMA), the EU equivalent of the FDA, said in a news release that the standard of care for managing COPD has changed because almitrine was originally authorized in the 3 European countries. Current clinical guidelines do not recommend the drug for COPD, "and the available evidence does not support a clinical benefit for long-term oral treatment with the medicine," according to the EMA.

 

French drug regulators asked the EMA to review almitrine in light of weight loss and neuropathy reported by some patients. Earlier this month, the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA recommended withdrawing market approval for the drug. PRAC noted at the time that cases of weight loss and peripheral neuropathy continued to crop up despite efforts to minimize those risks through dose reduction, breaks in administration, and label warnings.

 

The PRAC recommendation went to another EU agency called the Coordination Group for Mutual Recognition & Decentralised Procedures-Human, which harmonizes safety standards for medicines approved by individual EU nations. The group also endorsed the PRAC position, and as a result, France, Poland, and Portugal will pull almitrine from their respective markets, according to an agreed timetable that should be completed by July 25.

 

More information about the EU action on almitrine is available on the EMA Web site.

 

Medscape