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Reglan is a brand name for the drug metoclopramide, a powerful antiemetic that has been used for the treatment of gastroesophageal reflux disease (GERD), migraines, heartburn as well as a condition known as gastroparesis where food moves too slowly through the digestive system. Reglan is the only drug approved to treat gastroparesis. It is also used to treat nausea and vomiting during pregnancy and after chemotherapy. It was approved by the FDA in 1980 and was marketed by A.H. Robins, now Wyeth which is owned by Pfizer. FDA approved this drug for short-term treatment of stomach ailments, (4 to 12 weeks).
Reglan is considered as a dopamine antagonist and can cause condition like Tardive Dyskinesia. This condition is observed in patients who are being prescribed this medication for a longer period of time. People with Tardive Dyskinesia have difficulty controlling their bodies and are prone to have random, repetitive movements that can be mild or physically disabling. No known treatment is available for tardive dyskinesia. The symptoms may lessen or resolve after the discontinuation of treatment.
- Tongue protrusion
- Lip smacking, puckering or pursing
- Rapid eye blinking
- Rapid movements of trunk, legs and arms
- Random movements of fingers or toes
- Difficulty breathing
- Grunting and gasping
Another complication, which is uncommon but potentially fatal condition known as Neuroleptic Malignant Syndrome (NMS) is also associated with metoclopramide. Symptoms of NMS include fever, muscle rigidity, altered consciousness, irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac arrhythmias. Immediate discontinuation of metoclopramide is necessary to treat this condition.
In February 2009, FDA announced that this drug would carry a warning called as black box warning, alerting patient about the risk of Tardive Dyskinesia when drug is used for more than three months of period.
Evidence to be looked for in potential cases
- Usage of Reglan in Pharmacy Records
- Duration of Reglan usage in Medical Records
- Proof of injury and Treatment provided for injuries
Medical Record Review and claim validation of Reglan case should take approximately 90 minutes in most instances; however, this approximation may vary in cases based on the volume of records.