Reglan®



Jon L. Gelman LLC is investigating cases involving individuals who have suffered neurological reaction in the form of motion and movement control difficulties. Use of Reglan has been causally related with Tardive Dyskinesea, a neurological disorder.

On February 26, 2009 the U.S. Food and Drug Administration mandated that manufacturers of Metoclopramide-Containing drug place a black-box warning on all labels of the drug concerning long term use or high dose use of the drug.  "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."

Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products.

Symptoms

Regaln has been causally associated with the development of tardive dyskinesia. Tardive dyskinesia is a motor disorder that causes uncontrolled movements and spasms. While patients with Parkinson’s disease have difficulty moving, those with tardive dyskinesia  have difficulty not moving.

If you or a loved one may have experienced tardive dyskinesia in connection with Reglan® use, please contact attorney Jon Gelman at jon@gelmans.com or +1 973.696.7900.

US Food and Drug Warning

Chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. The elderly, especially elderly women, are most likely to develop this condition.

Metoclopramide therapy should routinely be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia; however, in some patients symptoms may lessen or resolve after metoclopramide treatment is stopped.

Prolonged treatment (greater than12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks to the patient of developing tardive dyskinesia.

Drug History and Serious Adverse Reactions

The U.S. Food and Drug Administration announced on February 26, 2009, that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, 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.

Manufacturers will be required to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.

The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment, said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.

Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

Metoclopramide works by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines. It is used as a short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies, and to treat diabetic gastroparesis (slowed emptying of the stomach's contents into the intestines). It is recommended that treatment not exceed three months.

Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products.

Recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders. Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used metoclopramide took it for longer than three months. The FDA has also become aware of continued spontaneous reports of tardive dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than three months.