Pharmaceutical history - February 7th - Metoclopramide approval

In February 7th 1979 the FDA approved as a new molecular entity the active pharmaceutical ingredient Metoclopramide under the trade name Reglan, manufactured by the pharmaceutical company West-Ward Pharms int.

Metoclopramide was first described by Louis Justin-Besançon andCharles Laville in 1964, while working to improve the anti-dysrhythmic properties of procainamide. That research project also produced the product sulpiride. The first clinical trials were published by Tourneu et al. in 1964 and by Boisson and Albot in 1966. Justin-Besançon and Laville worked for Laboratoires Delagrange and that company introduced the drug as Primperan in 1964. Laboratoires Delagrange was acquired by Synthelabo in 1991 which eventually became part of Sanofi.

A.H. Robinsintroduced the drug in the US under the tradename Reglan in 1979 as an injectable and an oral form was approved in 1980. in 1989 A.H. Robins was acquired by American Home Products, which changed its name to Wyeth in 2002.

The drugs were initially used to control nausea for people with severe headaches or migraines, and later uses for nausea caused by radiation therapy and chemotherapy, and later yet for treating nausea caused by anesthesia. In the US the injectable form was labelled for chemotherapy-induced nausea and the oral form was eventually labelled for gastroesophageal reflux disease.

It became widely used in the 1980s, becoming the most commonly used drug to treat anesthesia-induced nausea and for treating gastritis in emergency rooms.

The first generics were introduced in 1985.

In the early 1980s signs began to emerge in pharmacovigilance studies from Sweden that the drug was causing tardive dyskinesia in some patients. The FDA required a warning about tardive dyskinesia to be added to the drug label in 1985 stating that: "tardive dyskinesia . . . may develop in patients treated with metoclopramide,” and warned against use longer than 12 weeks, as that was how long the drug has been tested. In 2009 the FDA required that a black box warning be added to the label.

Source https://en.wikipedia.org/wiki/Metoclopramide#History
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