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Reglan

The gastrointestinal injury attorneys at the Drug Law Center are currently evaluating potential Reglan compensation claims for metoclopramide medication users suffering from Tardive Dystonia, Tardive Dyskinesia, or another associated condition.

What is Reglan?

Reglan (metoclopramide) RecallsReglan (metoclopramide) is a gut motility stimulating medication prescribed by doctors to treat GERD (gastroesophageal reflux disease) and gastroparesis in individuals suffering from diabetes mellitus. The medication is designed to increase upper digestive tract muscle contractions to empty the stomach into the intestines at the proper rate. Some doctors prescribe Reglan is a short-term solution for treating GERD-associated heartburn in individuals who have found no relief of their symptoms after using other drugs.

History of Reglan

The active ingredient in Reglan, metoclopramide, was first formulated by scientists at Laboratoires Delagrange in the 1960s before the company was acquired by Synthelabo in 1991, a subsidiary of Sanofi. Auckland New Zealand drug maker A.H. Robbins Company Inc. initially manufactured, marketed and promoted Reglan before the company was sold to Wyeth Pharmaceuticals, who eventually sold the liabilities and rights associated with the medication to Schwarz Pharma, Inc. in 2001.

Originally, the drug maker sold metoclopramide to control nausea in individuals suffering from migraines and severe headaches. In the years following, doctors prescribed the medication to treat chemotherapy/radiation therapy-related nausea and nausea associated with anesthesia.

By the 1980s Swedish scientists identified a correlation of taking medications containing metoclopramide and the development of tardive dyskinesia, a typically incurable kind of movement disorder. Dyskinesia causes repetitive, involuntary body movements. At that time, the Food and Drug Administration require the company to warn consumers through label changes about the potential side effects including tardive dyskinesia stating that the condition “may develop in patients treated with metoclopramide.”

The FDA warned consumers to not use the product any longer than twelve weeks because that is how long clinical trials testing the medication has provided data. By 2009, the federal agency required manufacturers of medications containing metoclopramide to add the prescription time on to its black box warning label. After identifying the correlation of taking the drug and the development of severe side effects, Wyeth pharmaceuticals Inc. began facing multiple lawsuits of product liability litigation cases filed by injured patients.

Reglan Side Effects

Like every medication, Reglan and other drugs containing metoclopramide have mild to severe side effects and adverse reactions in some individuals. The most common Reglan side effects include:

  • Diminished energy
  • Dizziness
  • Drowsiness
  • Diarrhea
  • Tiredness
  • Malaise
  • Restlessness
  • Vomiting
  • Breast swelling or tenderness
  • Insomnia (difficulty in sleeping)
  • Unexpected changes in your menstrual cycle
  • Unexpected increased urination

More severe Reglan side effects include:

  • Uncontrollable muscle movement (tardive dyskinesia)
  • Depression
  • Muscle stiffness
  • Muscle spasms (shaking)
  • Difficult/slowed movement
  • Swollen hands
  • Difficulty in breathing
  • Agitation
  • Suicidal ideation (the thought of suicide)
  • Diminished libido (decreased sexual drive)
  • Mood/mental changes
  • Allergic reactions

Extrapyramidal Side Effects and Reglan

Extrapyramidal side effects are movement disorders including tardive-acute symptoms that are caused by taking medications formulated with metoclopramide, including Reglan. These serious side effects can cause tremors, continuous muscle contractions and spasms (dystonia), motor function restlessness (akathisia), rigidity symptoms (pseudo-parkinsonism), slow movement (bradykinesia), and jerky irregular movements (tardive dyskinesia). These conditions are typically extremely difficult to treat.

In February 2009, the Food and Drug Administration required Wyeth Pharmaceuticals Inc. to update the black box warnings to include the potential risks of developing tardive dyskinesia after using Reglan for an extended period. The agency stated that the consumer could develop a dangerous central nervous system disorder that produces permanent repetitive, involuntary body movements from using the medication.

Tardive Dyskinesia and Reglan

While tardive dyskinesia is a common side effect for individuals taking Reglan or the generic form metoclopramide, it typically only occurs in individuals suffering from a psychiatric condition who have been taking antipsychotic drugs for years. In addition, the elderly are highly susceptible to developing tardive dyskinesia, especially elderly females. The risks of development are significantly lower in younger women and men equally. However, alcoholics, diabetic patients, and those undergoing electro-convulsive therapy tend to be at a higher risk of developing the condition.

Social isolation is a serious condition that affects many individuals suffering from tardive dyskinesia. In addition, the condition can increase the potential risk of developing dysmorphophobia and increases the potential of suicidal ideation and suicidal action. Additionally, physical stress and emotional anxiety can elevate the severity of the individual’s dyskinetic movements where sedation and relaxation have opposite effects.

Who Should Avoid Taking Reglan?

Nearly every type of drug has some type of contraindication, where certain patients should avoid taking the medication to avoid injury, harm, or premature death. The most common contraindications when taking Reglan involve:

  • Water retention
  • High blood pressure
  • Parkinson’s symptoms
  • Rapid eye blinking and movement
  • Lip smacking
  • Muscle issues causing abnormal movement
  • Severe to moderate kidney impairment
  • Seizures
  • Hardening of the liver
  • Impaired and involuntary finger movement
  • Protrusion
  • Neuroleptic malignant syndrome
  • Depression
  • Pheochromocytoma (adrenal medulla-located small vascular tumor)

Reglan and Pregnancy

The U.S. National Library of Medicine, National Institutes of Health, issued a warning in October 2013 stating that the potential risk of genetic malformations and fetal death has yet to be determined and women who took drugs containing metoclopramide to treat their vomiting and nausea symptoms during pregnancy. The federal agency noted that the medication is thought to be safe and labor the product as a Pregnancy Category B drug meaning that no correlation proving harm to the unborn child has been found in pregnant women taking Reglan during their first trimester.

That said, the agency is recommending that the drug only be prescribed to pregnant women when necessary. The FDA has not yet indicated that taking Reglan or any metoclopramide medicine as a treatment for vomiting or nausea caused by pregnancy. Approval by the Food and Drug Association has only been given for treating GERD-associated symptoms and other medical conditions associated with diminished gastrointestinal emptying.

Reglan Lawsuits

Many individuals have been harmed by dangerous medications will file a lawsuit against the pharmaceutical maker in an effort to recover their financial damages. Some of these cases involve:

  • Pharmaceutical Giant Loses Appeal against Alabama Supreme Court
    August 2014 – Pfizer subsidiary Wyeth Pharmaceuticals loses the appeal of a Reglan lawsuit that had been filed by an Alabama resident who developed tardive dyskinesia after taking the generic form of Reglan, metoclopramide, which was prescribed by his doctor. In the original lawsuit, the plaintiff alleged that Wyeth had failed to warn him about the potential risks related to using metoclopramide long-term. The pharmaceutical giant argued that as the drug maker for the brand name medication they could not be held responsible for the injuries suffered by the patient because he had taken the generic version and not the brand-name medication.However, the Alabama Supreme Court decided 6 to 3 that the prescription drug maker could be found legally liable for its failure to warn the public of the associated risks from taking metoclopramide. Their decision upholds the previous year’s decision.

    The highest court disagreed with Pfizer stating that the medication manufacturer’s attorneys had “completely ignored the nature of prescription medication.” The judges noted that drug warnings are important for physicians writing prescriptions stating that “when the warning to the prescribing health care professional is inadequate… the manufacturer is directly liable to the patient for damage resulting from that failure.”

    The court reminded the pharmaceutical manufacturer that under current law, generic medication manufacturers must wait for changes in black box warnings posted on the product have been upgraded by the brand-name manufacturer.

  • Metoclopramide Lawsuits to Proceed after Ruling by New Jersey Appellate Court
    November 2014 – The New Jersey Law Journal reported that the New Jersey appellate Court has ruled that cases involving drug makers who failed to warn are not preempted by federal law. This has been a contentious issue for years. However, the ruling by the three-judge panel paves the way for future metoclopramide lawsuits. They judges stated that pharmaceutical manufacturers should update their labels in a timely manner after new side effects and adverse effects are discovered, identified, or observed. The judges stated that the drug maker is only immune if their generic versions contain identical warning labels as posted on the brand-name medication.
  • Motion to Form MDL (Multidistrict Litigation) Reglan Lawsuit Rejected by the Federal Court
    2009 – The federal court has rejected the consolidation of litigation involving numerous Reglan lawsuits filed by plaintiffs who were injured by the medication for the purposes of minimizing the confusion of pretrial motions and discovery involving similar evidence. Even though the court rejected the motion, the judge stated that plaintiffs could move ahead with their litigation in individual courts throughout the nation to seek compensation for their harm.
  • New Jersey Supreme Court Rules in Favor of Plaintiffs Centralizing Their Reglan Lawsuits
    July 2010 – The New Jersey Supreme Court has ruled that numerous Reglan lawsuits could be centralized for the purpose of streamlining case management. However, the state court had ruled that these cases must be filed and heard only in Superior Court Judge Higbee’s courtroom.
  • Reglan Lawsuit Financial Settlement May Not Be Far off for Thousands of Plaintiffs
    2004 – The Food and Drug Administration required all drug makers manufacturing products containing metoclopramide to update their black box warning labels. The federal agency mandated that these companies provide additional information concerning the increased potential risk of developing tardive dyskinesia after taking high doses of Reglan (metoclopramide) for an extended period. The federal agency stated that long-term use can cause various side effects including involuntary muscle movements of the legs, arms, eyes, tongue, lips, and face.

The Legal Intelligencer has reported that a proposed settlement is in the works to settle thousands of Reglan injury lawsuits filed by plaintiffs across the United States who suffer from permanent severe muscle disorders including tardive dyskinesia.

Hiring an Attorney

The nervous system injury attorneys at the Drug Law Center are continuing their investigation and evaluation of potential Reglan lawsuits for clients suffering from drug-induced movement disorders including tardive dyskinesia. Our attorneys have years of experience in handling cases involving metoclopramide (Reglan) and hold pharmaceutical companies responsible for selling a defective product that has serious side effects.

If you are suffering from a serious side effect caused by Reglan our team of dedicated attorneys can help. Our law firm specializes in medical malpractice, wrongful death, and product liability cases. We fight aggressively on behalf of our clients to ensure they receive the highest level of financial compensation for their damages. We provide free initial case consultations to discuss your case and can offer numerous legal solutions on how to proceed.

Our firm is currently postponing payment of our legal services until after we have successfully resolved our clients’ cases. We provide a “no-win/no fee” guarantee, meaning if we are unsuccessful in obtaining an acceptable out-of-court settlement or winning your case at trial, you owe us nothing.

Sources:

https://www.fda.gov/downloads/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm111376.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017854s058lbl.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3676933/

http://www.thelegalintelligencer.com/id=1202613789224/Lawyers-Superior-Court-Ignored-SCOTUS-in-Reglan-Ruling?slreturn=20170423130714

 

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