Tardive dyskinesia is a variety of dyskinesia (involuntary, repetitive movements) manifesting as a side effect of long-term or high-dose use of dopamine antagonists, usually antipsychotics. Other dopamine antagonists that can cause tardive dyskinesia are drugs for gastrointestinal disorders (e.g. metoclopramide / Reglan) and neurological disorders. While newer atypical antipsychotics such as olanzapine and risperidone appear to have less dystonic effects, only clozapine has been shown to have a lower risk of tardive dyskinesia than older antipsychotics.
FDA Reglan Side Effects Warning
As of March 3, 2009 the FDA has required that a black box warning (the strongest FDA warning) on all drugs containing the pharmaceutical ingredient metoclopramide including Reglan, which is used in the treatment of disorders like heartburn caused by gastroesophageal reflux disease.
BLACK BOX WARNING: TARDIVE DYSKINESIA
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
Metoclopramide Warning
Metoclopramide can be found in Reglan tablets, oral disintegrating pills, metoclopramide oral solution and Reglan injections. All of these metoclopramide-containing prescription drugs already contain box warnings, but the seriousness of the risk of developing tardive dyskinesia (involuntary movements) will now be highlighted by the FDA's strongest available warning.
Any patient taking Reglan or other forms of metoclopramide should have been warned of the risk of tardive dyskinesia by their doctor prior to being prescribed the drug. The risk increases the longer a patient takes metoclopramide, and with higher doses. FDA studies show that around 20 percent of patients who developed drug-induced movement disorders after taking Metoclopramide had taken the drug for more than three months.
Reglan & Metoclopramide Side Effects
As the FDA has reported, some patients taking Reglan or other metoclopramide containing products more than 12 weeks have developed repetitive, involuntary movements including:
- Facial Twitches
- Grimacing
- Frowns & Stares
- Sticking one's tongue out
- Lip smacking,
- Puckering,
- Pursing of the lips,
- Rapid movement of arms,
- Rapid involunatry movements of legs,
- Involuntary movements of fingers or toes,
- Rapid eye blinking
- Twitching
- Other Parkinson like movements
* If you have taken Reglan or other metoclopramide-containing prescription drugs and have developed any of the above side effects or have taken this drug for more than 12 weeks, it is advisable to consult your doctor or go to a neurologist and get a second opinion as to the diagnosis and cause of the tardive dyskinesia or other medical problems.
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