Reglan Side Effects Lawyer Issues Warning to Migraine and Cluster Headache Victims Taking Reglan
. By Baum Hedlund
Los Angeles, CAReglan is not FDA-approved for people suffering from migraines, chronic headaches or cluster headaches, yet the anti-nausea drug, also known as metoclopramide, is frequently prescribed off-label to treat nausea and vomiting for headache sufferers.
Reglan 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 is not approved by the FDA, physicians have been prescribing Reglan widely and globally to treat 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. Patients demonstrate 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—added stronger language about the risk of tardive dyskinesia to the prescription labeling. 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. "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," says Drake.
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 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.