Metoclopramide is most commonly known in the U.S. by the brand name Reglan, made by Schwarz Pharma. Salix Pharmaceuticals also just received FDA approval to market in the U.S. an orally disintegrating metoclopramide tablet by the name of Metozolv. Metoclopramide is also sold in other countries under the brands Maxolon, by Shire/Valeant, Degan by Lek, Maxeran and Primperan by Sanofi Aventis, and Pylomid by Bosnalijek.

The medication is primarily used to facilitate gastric emptying in patients with gastroparesis, and in the treatment of severe GERD. It also is used to treat nausea and vomiting, morning sickness, migraine headaches, and has been shown to stimulate lactation in nursing women.

Because metoclopramide is a dopamine antagonist, it may worsen the symptoms of Parkinson’s disease. It is also contraindicated for patients with a suspected bowel obstruction and those who suffer from clinical depression, as it may aggravate symptoms of depression. But long-term use, which is necessary in some patients, especially those suffering from gastroparesis, has been shown to cause the Parkinson’s-like symptoms of Tardive Dyskinesia among otherwise healthy people. Because of the new black box warning issued by the FDA, labeling for metoclopramide medications now carry a warning of Tardive Dyskinesia. Unfortunately, the warning is too late for many who know find themselves with a diminished quality of life from a medication that was to designed to improve their quality of life.

SOURCE: Reglan Side Effects › Metoclopramide can diminish quality of life

Questcor Pharmaceuticals Inc

Diabetes is just one of the known causes of gastroparesis. The condition is generally treated through dietary changes and medications including metoclopramide, which is commonly found under the brand names Reglan, Maxolon or Clopra and is traditionally available in the form of a tablet,  oral solution or injection.

The clinical trail on Questor’s Emitasol metoclopramide nasal spray showed encouraging results in terms of safety and preliminary evaluation of efficacy in the treatment of diabetic gastroparesis. No serious adverse events were reported during the trial.

In recent months, the Food and Drug Administration (FDA) placed a black box warning on the drug metoclopramide – the strongest warning required by the FDA – after a serious condition called Tardive Dyskinesia was reported in a number of patients who took the drug. Tardive Dyskinesia is a Parkinson’s-like condition in which a person develops involuntary movements of his muscles, including lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, lip puckering and involuntary movements of the fingers. The condition can be permanent, even after the drug has been discontinued.

Questor says it plans to begin Phase III of the Emitasol study as soon as possible.

Source: PR Newswire

SOURCE: Reglan Side Effects › Clinical trial underway for metoclopramide nasal spray