California Metoclopramide® Lawyers

Metoclopramide--also known as Reglan©--increases muscle contractions in the upper digestive tract, which increases the rate the stomach empties. Metoclopramide can be prescribed for heartburn caused by gastroesophageal reflux, or as an aid to individuals with diabetic gastroparesis tp counter the nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness after meals that occurs with that condition. Drugs that contain metoclopramide include Reglan tablets, Reglan oral disintegrating tablets, metoclopramide oral solution, and Reglan injection. According to the FDA, more than 2 million Americans use these products.

The drug was marketed by Wyeth for a number of years. However, the Madison, N.J.-based company sold the tablet form to Schwarz Pharma in 2001 and the injectable form to Baxter International in 2002. The drug also is marketed by a number of generic companies. The FDA based its warning decision on recently published studies suggesting metoclopramide is the leading cause of pharmaceutical-related movement disorders. One study showed that roughly 20 percent of patients who take the drug longer than three months develop dyskinesia

The FDA has published a warning letter which states that "the U.S. Food and Drug Administration announced today that manufacturers of metoclopramide or Reglan©, 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."

Pediatric
Muscle spasms, especially of jaw, neck, and back, and tic-like (jerky) movements of head and face may be especially likely to occur in children, who are usually more sensitive than adults to the effects of metoclopramide. Premature and full-term infants may develop blood problems if given high doses of metoclopramide.

Geriatric
Shuffling walk and trembling and shaking of hands may be especially likely to occur in elderly patients after they have taken metoclopramide over a long time

Feb. 27, 2009 -- The FDA has ordered a "black box" warning, the FDA's strongest warning, for drugs that contain metoclopramide, which is used to treat gastrointestinal disorders. The FDA warns of continued, spontaneous reports of tardive dyskinesia in patients who used metoclopramide, most of whom had taken the drug for more than three months.

• Solution
• Syrup
• Tablet

The product insert warns of the following:

• Abdominal pain or tenderness
• Chills
• Clay colored stools
• Convulsions
• Dark urine
• Difficulty in breathing
• Difficulty in speaking or swallowing
• Dizziness or fainting
• Fast or irregular heartbeat
• Fever
• General feeling of tiredness or weakness
• Headache (severe or continuing)
• Inability to move eyes
• Increase in blood pressure
• Increased sweating
• Itching
• Lip smacking or puckering
• Loss of appetite
• Loss of balance control
• Loss of bladder control
• Mask-like face
• Muscle spasms of face, neck, and back
• Nausea and vomiting
• Puffing of cheeks
• Rapid or worm-like movements of tongue
• Shuffling walk
• Skin rash
• Sore throat
• Stiffness of arms or legs
• Swelling of feet or lower legs
• Trembling and shaking of hands and fingers
• Tic-like or twitching movements
• Twisting movements of body
• Uncontrolled chewing movements
• Uncontrolled movements of arms and legs
• Unusually pale skin
• Weakness of arms and legs
• Yellow eyes or skin

• Aching or discomfort in lower legs
• Panic-like sensation
• Sensation of crawling in legs
• Unusual nervousness, restlessness, or irritability
• Diarrhea—with high doses
• Drowsiness
• Restlessness
• Breast tenderness and swelling
• Changes in menstruation
• Constipation
• Decreased interest in sexual intercourse
• Inability to have or keep an erection
• Increased flow of breast milk
• Increased need to urinate
• Loss in sexual ability, desire, drive, or performance
• Mental depression
• Nausea
• Passing urine more often
• Skin rash
• Trouble in sleeping
• Unusual dryness of mouth
• Unusual irritability

Metoclopramide® References

• Tardive dyskinesia: summary of a Task Force Report of the American Psychiatric Association. By the Task Force on Late Neurological Effects of Antipsychotic Drugs.Am J Psychiatry 1980; 137:1163-1172 Copyright © 1980 by American Psychiatric Association
• FDA slaps warning on heartburn drug tied to spasms.
• Practical Gastroenterology May 2004 Recognition of Movement Disorders and Extrapyramidal side effects
• Tardive Dyskinesia: Tremors in Law and Medicine Neil S.Kaye, MD, FAPA, and Thomas J. Reed Esquire. Journal of theAmerican Academy of Psychiatry and the Law, 1999; Volume 25,No 2.
• Assessment of drug-related movement disorders in schizophrenia Maurice Gervin and R.E. Thomas Barnes Advances in Psychiatric Treatment, 2000; 6: 332-341

If you have experienced while taking Reglan© or Metoclopramide ; or were otherwise injured by taking Reglan© or Metoclopramide;, you are entitled to compensation. If you or a family member have taken Metoclopramide® and developed problems, you should seek a free consultation regarding your legal rights. Our Metoclopramide/ Reglan© lawyers have the experience and resources necessary to obtain compensation from pharmaceutical companies.

Lawsuits have been filed over Metoclopramide/ Reglan©. There are indications that has downplayed the known risks of Metoclopramide® usage. If you have experienced complications, you can act now. We can help you get the compensation you deserve.

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