What is Reglan® | Reglan's Black Box Warning | Off-Label Uses
Alert for Pregnant Women & Nursing Mothers | Alert for Migraine & Cluster Headache Victims
More Warnings Needed on Reglan Side Effects

Reglan Side Effects Lawyer's Warning to Migraine and Cluster Headache Victims taking Reglan: You could be at risk of developing an irreversible neurological disorder.

Reglan is not FDA-approved for people suffering from migraines, chronic headaches or cluster headaches, yet the anti-nausea drug, also known as metoclopramide, is being prescribed “off label” to treat nausea and vomiting for headache sufferers.


Tardive dyskinesia injury lawyer, Roger D. Drake,
explains why people should be concerned

Metoclopramide (both in pill and injectable form) has been used off-label to treat nausea and vomiting caused by migraines and cluster headaches. Although this use had not been approved by the FDA, physicians have widely and globally prescribed Reglan for the treatment of migraines for decades. Reglan is mostly taken alongside pain medication to treat migraines and has been shown to allow a patient to better tolerate and absorb these medications.

Patients taking metoclopramide could develop tardive dyskinesia, a disabling and often irreversible neurological condition. Tardive dyskinesia is characterized by involuntary and repetitive muscle movements. The disabling condition includes the following symptoms:

  • Involuntary / repetitive movements of the extremities
  • lip smacking
  • grimacing
  • rapid eye movements
  • blinking and impaired movement of the fingers.
A black box warning was issued by the FDA for metoclopramide on February 26, 2009. This warning, the strictest alert the FDA can issue, enhanced the prescription labeling by adding stronger language about the risk of tardive dyskinesia. According to the warning "the risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose.”

Treatment longer than 12 weeks significantly increases the risk of developing tardive dyskinesia. According to Reglan injury lawyer, Roger D. Drake, "The black box warning fails to mention that metoclopramide can cause this condition even with short term use, although the risk grows with long term use."

Tardive dyskinesia has no known treatment and can last a lifetime, affecting a victim physically, mentally, emotionally, socially and vocationally.

The FDA has only approved metoclopramide tablets for the treatment of gastroesophageal reflux disease (GERD), and for the treatment of diabetic gastroparesis.  The injectable solution of metoclopramide has been approved for the treatment of nausea and vomiting associated with cancer chemotherapy and to prevent the nausea or vomiting that may occur after surgery. 

The black box warning indicates that Reglan should only be used on a short term basis.

What is Reglan® | Reglan's Black Box Warning | Off-Label Uses
Alert for Pregnant Women & Nursing Mothers | Alert for Migraine & Cluster Headache Victims
More Warnings Needed on Reglan Side Effects

Baum, Hedlund, Aristei & Goldman is recognized as a preeminent plaintiff national mass disaster law firm which handles personal injury, wrongful death and consumer class actions across the U.S. They routinely handle complicated evidence and choice of law issues in both state and federal courts throughout the country.

Share |