What is Reglan?
What are the dangers associated with Reglan?
Recently, the Food and Drug Administration (FDA) issued a black box warning to consumers and healthcare providers warning of the risk of tardive dyskinesia with the long-term or high-dose use of metoclopramide, more commonly known as Reglan. Tardive dyskinesia is a condition in which a person develops involuntary movements of their muscles.
Long-term users of the drug, and elderly patients, especially women are at an increased risk of developing Tardive Dyskinesia. There is no known cure for Tardive Dyskinesia and even after discontinuing the drug, symptoms may still persist.
Tardive Dyskinesia may present with the following involuntary muscle movements:
- lip smacking
- tongue thrusting
- eye blinking and bulging
- head jerking
- facial grimacing
- puckering and pursing of the lips
- involuntary movements of the fingers
Metoclopramide is available in formulations including tablets, syrups and injections, under names including Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injections.
According to the FDA, it is estimated that more than 2 million American use these products.
In a recent FDA news release, the agency states that manufacturers of the drug metoclopramide, or Reglan, will be required to implement a risk evaluation and mitigation strategy (REMS) to ensure patients are provided with a medication guide that discusses the risk of Tardive Dyskinesia. Read the letter requiring compliance with REMS.
According to the news release, analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders. About 20 percent of the patients in that study used the drug for longer than three months.
What can I do?
If you or a loved one has suffered Tardive Dyskinesia as the result of taking Reglan, you may be entitled to compensation. For a free legal consultation, contact us today!