- 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 DyskinesiaReglan (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 WarningIn 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:
Off-Label Reglan UseReglan 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 EffectsOther 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 HelpIf 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 Apr-19-10