Reglan®

NOTE: If you have taken Reglan® or a generic equivilent and suffer from tardive dyskinesia, you may be entitled to compensation. Please call Tim Edwards or Ed Wallis today at (901) 527-2125, send us an e-mail by clicking HERE, or fill out the form below for a free case evaluation.

In February 2009, the Food and Drug Administration notified healthcare professionals that the manufacturers of metoclopramide drugs, including Reglan®, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use: “Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible and there is no known treatment.”

About Reglan®

Reglan® (a marketed name of the drug Metoclopramide) is a prescription drug used for the treatment of certain types of acid reflux; it is intended for short-term use. Reglan® is also sometimes prescribed for patients with diabetic gastroparesis, a disorder where the stomach takes too long to empty its contents, causing intense heartburn, nausea and vomiting.  Studies have shown that Reglan® increases the muscle contractions in the patient’s upper digestive tract, which also increases the speed at which the stomach contents empty into the intestines.

Other Names

Besides Reglan, Metoclopramide is marketed under the names Octamide®, Maxolon®, Degan®, Maxeran®, Primperan®, and Pylomid®.

Side-Effects

Common side-effects of Reglan are relatively mild, such as drowsiness, nausea, and diarrhea. However, very severe responses to the drug, even death – has been reported.

Another side effect of more serious concern is Neuroleptic Malignant Syndrome, which has been reported in possible connection with Reglan® use.  This is a potentially life-threatening condition, Neuroleptic Malignant Syndrome can cause fever, muscle-rigidity, delirium, kidney damage, unstable blood-pressure, and coma.

Tardive dyskinesia, a neurological condition, has also been reported in patients prescribed Reglan. Symptoms of this condition can include involuntary grimacing, involuntary, rapid movement in the arms and legs, rapid eye blinking, and tongue protrusion. Conditions can become constant and more severe over time.  It is very important to note that the effects of Tardive dyskinesia can persist long after the patient’s use of Reglan® is finished. Even if you have not been officially diagnosed with tardive dyskinesia, if you are experiencing any of these symptoms, please contact us for a free case evaluation.

Seek Medical Help

Please seek medical attention if you have any of these symptons.  A skilled professional should be consulted on ways to try and alleviate your experiencing any fo the above.

More On Tardive Dyskinesia

Tardive Dyskinesia is a neurological condition whose chief symptoms are repetitive, involuntary movements.  The term tardive dyskinesia has been in use since 1964. The effect of the drugs that cause the condition can be tardive, meaning the dyskinesia (involuntary movement) sometimes appears even after the drugs are discontinued. Symptoms of tardive dyskinesia may include:

• Rapid eye blinking
• Repetitive and involuntary movements of the arms, legs, fingers, or toes
• Smacking, puckering, and pursing of the lips
• Sticking the tongue in and out (tongue protrusion)
• Swaying movements of the trunk or hips
• Uncontrolled grimacing

The Drug’s Warning Label

Tardive dyskinesia is often extremely embarrassing for the affected person, as the related movements are uncontrollable and unintentional.

The warning label of the drug cautions, “Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with metoclopramide. There is no known treatment for established cases of tardive dyskinesia.”

Black Box Warning Update

The Food and Drug Administration announced in February 2009 that Reglan manufacturers must add a black box warning—the strongest warning possible—to the class of the drug’s label regarding the risk of its long-term or high-dose use. Chronic use of the drug has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drug is no longer taken, according to the FDA.

The black box warning states: “Treatment with metoclopramide [Reglan] can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. Although the risk of TD with metoclopramide has not been extensively studied, one published study reported a TD prevalence of 20% among patients treated for at least 12 weeks. 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 TD.”

Contact Us For More Information

Visit the Frequently Asked Questions Page for more answers.

If you or a loved one have been prescribed Reglan® and have experienced any of these symptoms, please contact us immediately for a free consultation. Consult with your physician before you stop taking any medications, including Reglan®. Then contact us. Let us use our experience for you. We may be able to help.

Tim Edwards
Ed Wallis
Glassman, Edwards, Wade & Wyatt, PC
26 N. 2nd Street
Memphis, TN 38103
(901) 527-2125
(901) 275-0600 (after hours)
EMAIL BY CLICKING HERE

Or fill out this form today for a free case evaluation: