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Reglan

Reglan treats digestive conditions and GERD. Experts generally consider the drug to be safe, but it could include a risk of developing a movement disorder called tardive dyskinesia. The FDA now requires a black box warning on the medication.

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Reglan is the brand name of a drug called metoclopramide. It treats gastroesophageal reflux disease (GERD) and other digestive conditions that cause the intestinal tract to empty slowly.

Unfortunately, Reglan can cause a serious and often irreversible movement disorder called tardive dyskinesia (TD). This risk can increase depending on how long you take the medication and your dosage.

Some patients who developed TD after taking Reglan have filed lawsuits. If you’ve experienced adverse reactions to Reglan, consider talking to a lawyer to find out if you are eligible to take legal action.

What Is Reglan and Why Do Doctors Prescribe It?

Reglan is a medication used to treat certain digestive conditions. Its active ingredient is metoclopramide, which increases movements in your intestines and stomach.

Doctors use metoclopramide to treat:
  • Chemotherapy-induced nausea and vomiting
  • Gastroesophageal reflux disease (GERD)
  • Gastroparesis (slow stomach emptying) in diabetic patients

Common and Serious Side Effects of Reglan

Prescribing information indicates that drowsiness, fatigue, lassitude (weariness or lack of energy) and restlessness occurred in over 10% of patients taking Reglan. Confusion, dizziness, depression, headache, insomnia and suicidal ideation occurred less frequently than other side effects.

Common Side Effects
  • Drowsiness
  • Fatigue
  • Lassitude (physical or mental weariness)
  • Restlessness

Side effects tend to increase with dosage strength and duration. These reactions are often due to withdrawal symptoms and typically occur after stopping Reglan treatment, especially those affecting the nervous system.

Most common side effects are mild and resolve within a few days.

Serious Side Effects

Tardive dyskinesia is the most common serious Reglan side effect, along with other movement disorders, fluid retention and increased prolactin levels. Because TD and some other side effects may be permanent, report severe or persistent symptoms to your health care provider. If you notice unusual muscle or facial movements, notify your doctor immediately.

Most severe side effects from Reglan are rare, but some can cause permanent damage or death. Neuroleptic malignant syndrome, which causes a high fever and muscle stiffness, can lead to organ damage if left untreated. Increased prolactin levels can cause infertility and decreased sex drive, although they’re usually treatable and not life-threatening.

Severe Side Effects
  • Fluid retention, especially in those with liver disease
  • Increased prolactin levels, which can cause infertility
  • Neuroleptic malignant syndrome
  • Rapid, jerky, involuntary movements
  • Tardive dyskinesia

Reglan may also affect your mental and physical ability to operate a motor vehicle or heavy machinery. This can be exacerbated by certain antidepressants and other medications that can cause body movement disruptions, such as narcotics and sedatives.

Tardive Dyskinesia

Tardive dyskinesia is a neurological condition that can occur while taking Reglan. It is a serious potential side effect that prompted an FDA black box warning, the agency’s most serious medication alert. Patients who are over 65, assigned female at birth or diabetic are at an elevated risk of developing TD.

There is a direct link between dopamine receptor antagonists like Reglan and tardive dyskinesia. Earlier research, including a 1993 study published in the Archives of Internal Medicine, suggested that between 1% and 10% of patients using Reglan developed TD. However, newer research published in the journal indicates that the actual risk is much lower, with estimates around 0.1%.

TD causes involuntary movements and most commonly affects facial muscles. Symptoms include grimacing, jaw swinging, lip smacking, repetitive chewing, rapid eye blinking and tongue thrusting. It can also cause involuntary finger movements and rocking of the pelvis.

Symptoms may subside once you stop Reglan if your doctor diagnoses TD early. Treatments include dopamine-depleting medicines such as tetrabenazine and valbenazine, which may resolve mild symptoms. Deep brain stimulation, a surgical procedure in the brain that uses electrical stimulation, may also help relieve symptoms.

Involuntary movements from tardive dyskinesia may become permanent even after stopping your medication and undergoing treatment.

Reglan FDA Black Box Warning and Duration Limits

Reglan was approved by the FDA in 1979. Experts discovered the link between the medication and TD shortly after that. In 1985, the FDA required Reglan’s manufacturer to update its label, alerting patients to the risk of developing TD.

The FDA issued another label revision in 2009, focused on the length of Reglan use. The agency warned against taking the medication for more than 12 weeks.

Reglan’s black box warning states:
  • “Reglan can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage.”
  • “Discontinue Reglan in patients who develop signs or symptoms of TD."
  • “Avoid treatment with Reglan for longer than 12 weeks because of the increased risk of developing TD with longer-term use."

In 2017, the FDA required another Reglan label update to address dosage and usage, emphasize warnings about the TD risk and clarify other dangers.

Reglan Lawsuits

There have been many Reglan lawsuits. Plaintiffs allege that Reglan caused them to develop TD or other serious side effects. They also claim that drug manufacturers did not properly warn them about the risks associated with the medication.

  • 2009
    Plaintiffs' attorneys in Reglan lawsuits requested the creation of a multidistrict litigation for claims that the medication caused TD. The court denied this request since several of the cases were advanced, and the actions didn’t share a single common defendant.
  • 2010
    The New Jersey Supreme Court approved the consolidation of all Reglan lawsuits and assigned the cases to Superior Court Judge Carol E. Higbee. In addition, the Philadelphia Court of Common Pleas consolidated Reglan cases, including those against Teva Pharmaceuticals
  • 2011
    The U.S. Supreme Court ruled that generic drug manufacturers couldn't be liable for failing to warn about the risks of generic metoclopramide because federal drug regulations prevented manufacturers of generic drugs from changing the label. The label must match that of name-brand Reglan.
  • 2014
    The New Jersey Supreme Court transferred Reglan lawsuits to Superior Court Judge Jessica R. Mayer as a multicounty litigation.
  • 2017
    Teva Pharmaceuticals and its subsidiaries reached a settlement to resolve pending Reglan lawsuits. The Philadelphia Court of Common Pleas accepted the settlement.
  • 2017
    The New Jersey Supreme Court reassigned Reglan litigation to Superior Court Judge James F. Hyland.
  • 2021
    The New Jersey Supreme Court transferred Reglan cases again, this time to Judge Bruce Kaplan, who reported that all cases had been resolved.

Drugwatch’s legal partners are currently not accepting Reglan cases.

Who Is Most at Risk?

Reglan presents a risk to all patients, but the risk is higher depending on how long you use the drug, your age, your assigned sex at birth and whether you are diabetic.

Those at highest risk of side effects include:
  • Female patients
  • Patients with diabetes
  • People taking Reglan for 12 weeks or longer
  • Those over the age of 65

Anyone who takes Reglan should be aware of the dangers, especially if they fall into any of these categories.

What Reglan Users Should Do Next

If you are using Reglan, watch for signs of side effects and speak with your doctor if you have concerns. Be sure to document your usage of the medication and any side effects your doctor verifies.

You should also avoid taking Reglan for longer than the recommended 12 weeks. Reach out to an attorney if you experience unexpected side effects to determine if you might be eligible to file a lawsuit.

Please seek the advice of a medical professional before making health care decisions.