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Reglan Side Effects: Tardive Dyskinesia

For users of Reglan (Metoclopramide) side effects could cause Tardive Dyskinesia and other movement disorders. The lawyers at Saiontz & Kirk are no longer investigating Reglan Side Effects Lawsuits.  The information on this page is provided for information purposes only.

Reglan (metoclopramide) works by increasing the speed at which the stomach empties into the intestines.  It is approved for short term use (4 to 12 weeks) to treat GERD (gastroesophageal reflux disease), heartburn and acid reflux disease.

Reglan side effects have been linked to a risk of Tardive Dyskinesia, a permanent and disabling condition which causes repetitive, involuntary and purposeless movements, such as:

  • Grimacing, Puckerinig or Pursing of the lips
  • Tongue Protrusion or Lip Smacking
  • Rapid Eye Movements and Blinking
  • Uncontrolled Movements of the Extremities and Fingers

Side effects of Reglan were not properly researched and evaluated by the drug makers and inadequate warnings were provided about the risk of developing this movement disorder, especially when the drug is used long-term.

REGLAN TARDIVE DYSKINESIA RISK

Although Reglan is marketed for treatment of conditions that are often chronic and long-term problems, the medication is only approved for use of less than 12 weeks.  Since there is little benefit in treating a long term condition with a short-term treatment, many doctors continue their patients on the medications for more than three months.  In fact, about 30% of all prescribed metoclopramide drugs are taken for more than 12 months.

Long-term or high dose use of dopamine antagonists like metoclopramide, the drug contained in Reglan and its generic equivalents, substantially increase the risk of Tardive Dyskinesia side effects.

Reglan induced tardive diskinsia is caused by damage to the system that uses and processes the neurotransmitter dopamine.  It causes an inability to stop moving, with constant, repetitive and involuntary movements, especially involving the lower face.    The problems often continue even after Reglan is stopped, are rarely reversible and have no effective treatment.

In 2009, the FDA began requiring the makers of Reglan drugs containing metoclopramide to place a “black box” Tardive Dyskinesia warning, indicating that Reglan (metoclopramide) side effects have:

“been shown to cause spasms and tics when used for long periods of time or at high doses.  The problems include uncontrollable movements of the limbs, face and tongue, and are usually irreversible, even after the patients stop taking the drug.”

METOCLOPRAMIDE SIDE EFFECTS UNDERSTUDIED AND UNDERESTIMATED

Although Reglan drugs containing metoclopramide have been marketed since 1985, and has been known to cause tardive dyskinesia and other related movement disorders for more than 20 years, the manufacturers failed to adequately study their drug and grossly underestimated the risk that users may suffer from the Reglan side effects.

While prior mentions of Tardive Dyskinesia as a side effect of Reglan were included on the warning label, the language was vague and only estimated the risk at 0.2%.  In addition, misleading and false information was provided that the side effects are reversible and will subside with time, which is usually not the case.

For decades the manufacturers have indicated that the incidence of tardive dyskinesia from Reglan side effects is only about 0.2%.  As early as 1989, researchers indicate that this estimate is likely not accurate and it has been suggested the true incidence rate is likely more than 100 times greater when used long-term or at high doses.  In addition, elderly can experience the Reglan Tardive Dyskinesia problems at much lower doses.

Recent analyses suggest that Reglan is the most common cause of drug-induced movement disorder side effects, yet the manufacturers never performed any studies of the safety associated with long-term metoclopramide side effects or whether it is effective for long-term use of more than 12 weeks.

METOCLOPRAMIDE LAWSUIT FOR TARDIVE DYSKINESIA SIDE EFFECTS

As a result of the false and misleading information provided by the manufacturers, doctors were given the impression that the Reglan tardive dyskinesia risk was extremely rare.  Therefore, many doctors did not even discuss this mtoclopramide side effect with their patients and did not consider it when deciding to continue their patients on Reglan medications for more than 12 weeks.

The new FDA warnings are designed to make sure that patients are fully informed about the Tardive Dyskinesia problems, as that could affect their decision to use the drug or to continue using it.  The FDA has determined that patient labeling could prevent serious adverse events by making sure that users are aware of the risk.

Potential metoclopramide lawsuits were reviewed throughout the United States by our Reglan attorneys for individuals who have been diagnosed with Tardive Dyskinsia or related problems.

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