Europe Adds Restrictions to Reglan

By August 12, 2013 July 16th, 2019 Reglan

According to recent reports, the acid reflux drug Reglan is now facing new restrictions in Europe because of the drug’s link to neurological disorders like tardive dyskinesia. These new restrictions were announced by the European Medicines Agency (EMA) in a July 26-dated press release.

The press release basically announced that the EMA’s Committee on Medicinal Products for Human Use (CHMP) was recommending that all drugs containing Reglan possess stricter warnings on the label. Reglan is now only sold in Europe in its generic form, which is called metoclopramide. Reglan in both forms is only recommended to be used for short periods lasting no longer than twelve weeks because of the neurological conditions it can cause. Tardive dyskinesia, the most common condition caused by Reglan, is characterized with patients experiencing involuntary movements of the extremities, lip smacking, tongue protrusion, excessive blinking and other symptoms.

The new recommendations for Reglan and metoclopramide-based drugs is that they are “to only be prescribed for short-term use of five days or less.” In addition, there are calls for the drug to only be prescribed for adults following chemotherapy, radiotherapy, surgery and for the management of migraines. The committee has also stated that the drug should “only be given to children over one year of age and then only to prevent nausea and vomiting from chemotherapy.”

Finally, the committee is recommending that Reglan “should only be used if other drugs are unavailable, can’t be tolerated or prove ineffective.” The committee’s recommendations still have to be approved by the CHMP before they can be adapted in the European Union. In the U.S., Reglan was issued a black box warning because of the serious adverse side effects linked to the pills, but the drug continues to be used.

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