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 (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 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 Jan-3-12 |
REGLAN ARTICLES AND INTERVIEWS
Your Reglan Lawsuit: Is Time Running Out on You?
 Washington, DC: Reglan side effects—some of them extremely serious and debilitating—have resulted for many in a Reglan lawsuit, as plaintiffs attempt to pursue compensation for a life and lifestyle negatively, and often permanently, impacted by taking the drug as prescribed. Reglan tardive dyskinesia, for example, can prevent one from doing his or her job safely. The involuntary shaking associated with the condition can also be socially embarrassing—especially for a young person.
Sad [READ MORE]
Supreme Court Rules on Generic Reglan against Tardive Dyskinesia Victims
 Washington, DC: The Supreme Court ruled today, in a 5-4 decision, that generic drug companies do not share the same level of responsibility as the makers of brand-name drugs to update their product labeling. The ruling effectively ends two separate lawsuits brought by two women who claim they suffered severe medical complications from using a generic form of Reglan. [READ MORE]
Three Texas Men Sue over Reglan Tardive Dyskinesia
 Marshall, TX: Three plaintiffs are taking a handful of defendants to court over the emergence of Parkinson's, Reglan tardive dyskinesia and another condition allegedly caused by the long-term use of metoclopramide (Reglan). According to the March 2 issue of the Southeast Texas Record, the plaintiffs claim they had no idea that using the drug over the long haul would trigger such debilitating adverse reactions [READ MORE]
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