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Friday, March 6, 2009

FDA Places “Black Box” Warning on Metoclopramide Drugs

The Food and Drug Administration (FDA) has placed a "black box" warning, their strongest possible warning, on metoclopramide drugs due to their link with a risk of developing tardive dyskinesia.

Metoclopramide drugs speed up the contractions of stomach muscles, facilitating the movement of stomach contents into the intestines. They are most commonly prescribed to treat the following conditions:

  • Diabetic gastroparesis – a slowed emptying of stomach contents into the intestines
  • Gastroesophageal reflux disease
  • Cancer patients experiencing nausea and vomiting from chemotherapy

One of the most common metoclopramide drugs on the market is Reglan. It can be taken in several different forms. Some of the forms of Reglan receiving the "black box" warning are Reglan tablets, Reglan oral disintegrating tablets, and Reglan injection.

The FDA has ordered this warning based on the fact that metoclopramide drugs have been linked to an increased risk of tardive dyskinesia, a condition causing victims to experience involuntary and repetitive body movements.

Some of the symptoms of tardive dyskinesia include:

  • Lip smacking and puckering
  • Grimacing
  • Tongue protrusion
  • Rapid blinking
  • Involuntary finger movements
  • Rapid movements of the arms and legs

The majority of metoclopramide patients developing tardive dyskinesia took the drug in high doses for longer than the recommended three month time period. The higher the dosage and the longer the drug is taken, the more severe the symptoms. In some patients, symptoms reduce over time. In others, they are permanent. Currently, there is no treatment for tardive dyskinesia other than to stop taking the drug that has caused the condition.

It is important to consult with an experienced pharmaceutical liability attorney when you have suffered an illness or injury from taking a dangerous drug. Pharmaceutical companies must be held accountable for negligently releasing drugs that cause harmful side effects to patients.

If you have a defective drug claim, the experienced attorneys at The Cochran Firm can help you receive fair compensation for your damages. Please contact our pharmaceutical injury attorneys today to schedule a consultation.

posted by Benjamin A. Irwin at 10:05 AM

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