Reglan (metoclopramide) is used to treat Gastroesophageal Reflux Disease (GERD), acid reflux disease and heartburn. While many Reglan side effects are minor, some patients have experienced serious side effects, including Tardive Dyskinesia. Some metoclopramide side effects, such as Neuroleptic Malignant Syndrome, can be fatal while others are permanent. Also at issue is the prescribing of Reglan for off-label uses, meaning for conditions that Reglan is not approved by the Food and Drug Administration to treat.
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Both the brand name drug, Reglan, and the generic form of Reglan, Metoclopramide, may be involved in Reglan litigation.
Reglan and Tardive Dyskinesia
Reglan Black Box Warning
Off-Label Reglan Use
Other Reglan Side Effects
Reglan Lawsuit FAQ
8 Things You Should Know about Reglan
Reglan and Tardive Dyskinesia
Reglan (metoclopramide) is used to treat Gastroesophageal Reflux Disease (GERD), heartburn and acid reflux disease. Although most side effects are temporary, a side effect that allegedly can be permanent is Tardive Dyskinesia.
 Tardive Dyskinesia is characterized by repetitive, involuntary, purposeless movements such as grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye blinking. Rapid movements of the arms, legs and trunk may also occur. Impaired movements of the fingers may appear as though the patient is playing an invisible guitar or piano.
The FDA has only approved Reglan for short term use (4 to 12 weeks), but approximately 30 percent of patients are being prescribed the medication for 12 months or longer; long-term Reglan use has been linked to Tardive Dyskinesia.
Tardive Dyskinesia is a horrible, devastating syndrome that can last a lifetime. It affects victims physically, mentally, socially, emotionally and vocationally.
Reglan Black Box Warning
In February, 2009, the US FDA announced that Reglan would now carry a black box warning, alerting patients about the risk of Tardive Dyskinesia when Reglan is used for longer than three months. Prior to that, Reglan's labeling mentioned Tardive Dyskinesia as a possible side effect but claimed the occurrence was rare.
Reglan Black Box Warning for Tardive Dyskinesia:
WARNING:TARDIVE DYSKINESIA
Chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. The elderly, especially elderly women, are most likely to develop this condition.
Metoclopramide therapy should routinely be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia; however, in some patients symptoms may lessen or resolve after metoclopramide treatment is stopped.
Prolonged treatment (greater than 12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks to the patient of developing tardive dyskinesia.
Off-Label Reglan Use
Reglan was approved for short-term use to treat GERD, acid reflux disease and heartburn. However, some patients are prescribed Reglan for longer-term use, 12 months or longer. Meanwhile, other patients are prescribed Reglan for uses not approved on the label. These include treatment of pregnancy-related nausea and morning sickness, lactation stimulation and treatment of migraine headaches.
Off-Label Reglan is sometimes prescribed to treat:
- Pregnancy-related Nausea
- Morning Sickness
- Lactation Stimulation
- Migraine Heachache with Nausea
Some forms of Reglan, such as the injectable version, are approved to treat nausea brought on by cancer chemotherapy. However, other uses of Reglan to treat cancer-related nausea, such as for radiation nausea, or the use of oral Reglan to treat chemotherapy nausea, may be off-label uses. Additionally, as with Reglan for chemotherapy induced nausea, Reglan is sometimes used to treat post-operative nausea.
Although off-label use of a drug is not illegal, it is not recommended because studies have not proven the drug to be safe and effective for such uses.
Other Reglan Side Effects
Other serious Reglan side effects include Neuroleptic Malignant Syndrome (NMS), which is often fatal. Patients can develop NMS after only short exposure to a drug. NMS symptoms include high fever, sweating, unstable blood pressure, stupor, muscular rigidity and autonomic dysfunction. Symptoms can appear within the first 2 weeks of taking a drug.
Further side effects include Parkinsonism, characterized by slight shaking, body stiffness, difficulty moving and difficulty keeping balance. Patients with Parkinson's disease may experience a worsening of Parkinson's symptoms when they take Reglan.
Reglan Lawsuit FAQ
Why is Reglan involved in any lawsuits?
Reglan (metoclopramide) has been linked to the development of Tardive Dyskinesia. Reglan received a black box warning about the risk of Tardive Dyskinesia in 2009. It has been alleged that the risk of Tardive Dyskinesia, particularly with longer term use of Reglan, was not broadly publicized enough to allow patients to fully know and understand the risk of Tardive Dyskinesia.
What is Reglan used for?
Reglan is approved by the FDA for the treatment of Symptomatic Gastroesophageal Reflux Disease (GERD) and Diabetic Gastroparesis. It is also used to treat nausea caused or brought on by cancer chemotherapy treatment. Reglan is not approved--that is, Reglan is considered "off-label"--for treatment of pregnancy-related nausea, morning sickness, lactation stimulation, and nausea brought on by migraine headache. Reglan is sometimes prescribed for regurgitation conditions in infants and children.
What is Tardive Dyskinesia? What are the symptoms of Tardive Dyskinesia?
Tardive Dyskinesia is a syndrome that is thought to be irreversible. With Tardive Dyskinesia, victims experience involuntary, repetitive movements--movements that cannot be controlled. The involunary movements can include facial "ticks" or gestures such as grimacing, tongue protrusion, lip smacking, puckering or pursing of the lips, rapid eye blinking; they can also include bodily movements such as those affecting the fingers, hands, arms, legs, shoulders--or even the torso. The effects of Tardive Dyskinesia can impact the ability to breathe, talk and swallow. Tardive Dyskinesia is a very serious condition that can only be identified and diagnosed by a physician.
What should I do if I am taking Reglan now?
As with any prescribed medication, you should speak with your doctor about why you are taking Reglan and what alternative medications may be available for your specific condition, the length and dosage of your Reglan prescription, and the benefits of taking Reglan vs. the risks that may be involved.
What should I do if I or someone I know has been affected by taking Reglan?
Because the potential side effects of Reglan can be both serious and irreversible, the costs involved with treatment can be substantial. It is recommended that you have a lawyer review the details of your case as you may qualify for an award.
Reglan Side Effects Legal Help
If you or a loved one has taken Reglan and subsequently suffered from tardive dyskinesia or other side effects, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on Mar-17-10
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REGLAN ARTICLES AND INTERVIEWS
Black Box Warning for Reglan Tardive Dyskinesia More Than a Year Old
 Washington, DC: The Internet is abuzz this week with news that the US Food and Drug Administration (FDA) has implemented a black box warning for Reglan and all other drugs containing metoclopramide. A black box warning is the strongest spanner the FDA has in its toolbox short of asking a manufacturer to remove a product from the market entirely. [ Read More ]
Reglan not Approved for Infant Use
 Seattle, WA: It is not uncommon for newborns to experience Gastroesophageal Reflux Disease (GERD), and when they do, they are frequently treated with Reglan. However, Reglan side effects in infants are still not well understood. Many parents who say they were unaware of the link between Reglan and tardive dyskinesia are now concerned that their children will suffer from the effects of Reglan all their lives. [ Read More ]
Research Study Seeks Means to Avoid Reglan Side Effects
 DeLand, FL: In an effort to avoid the complications that can arise from the treatment of gastroesophageal reflux disease (GERD), such as tardive dyskinesia, scientists at Avail Clinical Research have begun a series of studies seeking a new treatment for the debilitating disease. [ Read More ]
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