No decision on withdrawing nausea drug from local market — JFDA

AMMAN — The Jordan Food and Drug Administration (JFDA) on Saturday said it has not received any notification from the European Medicines Agency (EMA) to withdraw Motilium from the Jordanian market.

JFDA Director General Hayel Obeidat said the administration has contacted the medicine’s French manufacturing company and the French National Agency of Medicine with an inquiry about the status of Motilium in their markets before taking any decision.

Prescrire, an independent medical journal, has recently called on the EMA to withdraw the medicine from the European market.

According to several news reports, the periodical is claiming that Motilium, a drug used against nausea and vomiting, was responsible for between 25 and 120 sudden deaths in 2012.

“Domperidone (Motilium or other brands) has modest efficacy against nausea and vomiting. It increases the risk of heart rhythm disorders and sudden death,” the journal said.

“Based on data on reimbursements paid by the French health insurance system and the incidence of sudden death in France, Prescrire has shown it to be a likely hypothesis that as many as 25 to 120 sudden deaths were linked to domperidone in 2012 in France,” it added. 

“It is high time the European health authorities withdrew this drug from the market,” Prescrire said.

“We cannot withdraw the medicine from our market unless we receive something formal,” Obeidat told The Jordan Times over the phone on Saturday.

He noted that before receiving any notification, “it is up to consumers to decide whether to use it or not.”

However, he added that a study conducted on the medicine in 2005 claimed that it causes premature death, but the news was not then confirmed.

“Of course Motilium has minor side effects, like any other medicine, but there is no proof yet that it causes sudden death,” Obeidat noted.