Reglan

  • Reglan

Reglan is a brand name for the metoclopramide drug, 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. Vomiting and nausea experienced during pregnancy and chemotherapy can also be treated by Reglan. It was approved by the Food and Drug Administration (FDA) in 1980 and was marketed by A.H. Robins, now Wyeth, which is owned by Pfizer. The FDA approved this drug for a short-term treatment of stomach ailments (4 to 12 weeks).

Reglan is considered as a dopamine antagonist and can cause a condition like Tardive Dyskinesia. This condition is observed in patients who have been 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. Till date, tardive dyskinesia has no known treatment. However, the only positive sign is that once the treatment is discontinued the effects of the side effects and symptoms may lessen or even resolve.

A complication, which is an uncommon but potentially fatal condition known as Neuroleptic Malignant Syndrome (NMS) is 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.

Serious Alleged Injuries may include:

  • Grimacing
  • 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
  • Neuroleptic Malignant Syndrome (NMS)

FDA SAFETY WARNINGS:

  • In 2009: The FDA ordered a "black box" warning, for drugs that contain metoclopramide. This was to highlight the risk of tardive dyskinesia, or involuntary and repetitive movements of the body, with long-term or high-dose use of metoclopramide, even after the drugs are no longer taken.

Lawsuit Allegations:

  • Lawsuits claim that Reglan makers failed to adequately warn about the risk of tardive dyskinesia from Reglan that can have a devastating impact on an individual’s quality of life.
  • Reglan cases were ordered by the court to be assigned to Superior Court Judge Carol E. Higbee.
  • Reglan litigation was decided not be consolidated for pretrial litigation, and each case was to proceed through discovery and other phases individually.
  • Majority of cases were consolidated into proceedings in the states of California, Pennsylvania, and New Jersey.
  • In January 2017, settlement news was announced by the maker of a generic version of Reglan. In February 2017 it was reported by the company, to the U.S. Securities and Exchange Commission that it had agreed to settle the majority of approximately 4,000 lawsuits it faced over the drug.
  • The awards have ranged from small amounts to more than $1 million. Thousands of cases have been resolved through confidential settlements.

Evidences:

  • 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 2 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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