Video originally created by FDA -- posted by Lawsuit.com on May 8th, 2009
FDA is requiring that manufacturers of metoclopramide add a boxed warning to the label about the risk of tardive dyskinesia if the drug is used for long periods of time or at high doses. Metoclopramide stimulates motility in the upper GI tract and its uses include diabetic gastroparesis and gastroesophageal reflux disease. Metoclopramide is marketed as a generic and under several trade names, including Reglan.
Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, as well as grimacing, rapid blinking and impaired movement of the fingers. The risk of tardive dyskinesia associated with metoclopramide is increased among long-term users of the drug, and also among elderly patients, especially women. There is no known treatment, and the symptoms, which are rarely reversible, may persist even after the metoclopramide is discontinued. However, in some patients, the symptoms may lessen or resolve when the drug is stopped.
FDA’s advice to practitioners is to avoid the chronic use of metoclopramide except in rare cases where they believe the benefit outweighs the risk. FDA is requiring manufacturers of the drug to develop a medication guide explaining the risks, which will be provided to patients with each prescription.
Reglan, also known as Metoclopramide, may have been considered an advantageous drug. Yet, the life changing side effect from Reglan that may occur moments after intake or months following intake includes Tardive Dyskinesia, description as follows:
• Involuntary movements of the tongue, face mouth, jaw, eyes and other areas of the body
• Difficulty swallowing, resulting in the inability to eat
• Anxiety
• Cosmetic disfigurement due to facial and body involuntary movements
The FDA suggested a black box warning against long term use of the drug. Yet, reports of Tardive Dyskinesia erupting soon after the drug may make Reglan a concern for use for any period of time. The uses of Reglan include:
• Indigestion, nausea and vomiting due to Diabetic Gastroparesis
• Heartburn due to Gastroesophageal Reflux Disorder
• Migraine headaches, nausea and vomiting associated with Cancer
Other side effects of Reglan include, but are not limited to, jaundice, irregular heartbeat, incontinence, and suicidal tendencies.
The Core of the Reglan Dilemma
It is the action behind Reglan that appears to be the root of the problem. Reglan blocks dopamine in the brain. The neurological implications associated with Reglan may be temporary or permanent. The duration of use may play a role in the longevity of side effects. Reports have indicated that up to 25% of all patients taking dopamine blockers experience Tardive Dyskensia on a temporary or permanent basis. Add this to the fact that treatment options have not withstood the test of time, many people suffer with the side effects from Reglan on a permanent basis. As James Shaw, Attorney at Law of Houston Texas adds, “Tardive Dyskensia is one of the most debilitating condtions with disfurgurment that is incomprehensible for most people to understand. “ Current treatment options include:
• Tetrabenazine, to deplete dopamine
• Select Anti-Parkinsons medications such as Aricept and Baclofen
• Botox to paralyze the muscles that cause involuntary movement
If you have taken Reglan and experience side effects of Tardive Dyskinesia, personal injury attorneys that focus on product liability may be able to assist you. Because of the complexity of Reglan and Tardive Dsykinesia, only a select number of attorneys may manage such cases.
Tardive Dyskinesia is a neurological condition that may be induced by drugs that are designed to treat schitzophrenia patients.
The statistics estimate that up to 1 million suffer from Tardive Dyskinesia and 15-20% of patients using drugs that induce Tardive Dyskinesia will experience symptoms of Tardive Dyskinesia. Many Tardive Dyskinesia symptoms are left undetected until the condition becomes irreversible. As Jason Coomer, Attorney at Law, Austin Texas explains, “Typically, a psychiatrist will prescribe a drug and their patients will take the drug or the parents of minor patients will give the drug to their children without question. Ultimately, many Tardive Dyskinesia victims and their families do not realize that the symptoms are related to the drug. Thus, the diagnosis is often slow to surface. In the end, the symptoms become severe and are irreversible, particularly in the case of long term use.” In fact, the numbers of drugs on the market that may contribute to Tardive Dyskinesia are high, including:
It is important to note that the symptoms produced by Tardive Dyskinesia may not arise until after a long period of time following the use of Tardive Dyskinesia causing drugs. The side effects produced from such drugs may reduce the quality of life for individuals suffering from Tardive Dyskinesia. The most prevalent types of side effects from Tardive Dyskinesia are involuntary bodily, tongue or eye blinking movements.
Assistance on the Horizon
People suffering from Tardive Dyskinesia and their families may inquire about the types of assistance available for Tardive Dyskinesia victims through personal injury attorneys. Personal injury attorneys dedicate a significant amount time into research about Tardive Dyskinesia for their cases. They may be aware of doctors who can help patients with Tardive Dyskinesia to better manage symptoms. Doctors treating Tardive Dyskinesia patients may know about new drugs that may counter the side effects of Tardive Dyskinesia. Fro example, TARVIL, a medial food, has been documented to be useful in the treatment of Tardive Dyskinesia for male patients, according to a study published in the American Journal of Psychiatry, June 2003.
Personal injury attorneys may also evaluate the circumstances surrounding your case to help ensure that you receive adequate compensation for your condition. Tardive Dyskinesia lawsuits will not be initiated until cases are thoroughly evaluated by personal injury attorneys, but Tardive Dyskinesia patients may be awarded financial compensation to assist in managing their losses due to Tardive Dskinesia. As Edmund Schmidt, Attorney at Law of Nashville, Tennessee adds, “Currently, medical doctors have had lawsuits against them for prescribing drugs that cause Tardive Dyskinesia . Many have produced positive outcomes. The verdict is out on lawsuits involving the liability of pharmaceutical companies due to the pending Supreme Court decision regarding pharmaceutical company liability based on inadequate warnings to the public“
Tardive Dyskinesia is a neurological condition that may be induced by drugs that are designed to treat scitzophrenia patients. The statistics estimate that up to 1 million suffer from Tardive Dyskinesai and 15-20% of patients using drugs that induce Tardive Dyskinesia will experience symptoms of Tardive Dyskinesia. Many Tardive Dyskinesia symptoms are left undetected until the condition becomes irreversible. In fact, the numbers of drugs on the market that may contribute to Tardive Dyskinesia are high, including:
It is important to note that the symptoms produced by Tardive Dyskinesia may not arise until after a long period of time following the use of Tardive Dyskinesia. The side effects produced from such drugs may reduce the quality of life for individuals suffering from Tardive Dyskinesia. The most prevalent types of side effects from Tardive Dyskinesia are involuntary bodily, tongue or eye blinking movements.
Assistance on the Horizon
People suffering from Tardive Dyskinesia and their families may inquire about the types of assistance available for Tardive Dyskinesia victims through personal injury attorneys. Personal injury attorneys dedicate a significant amount time into research about Tardive Dyskinesia for their cases. They may be aware of doctors who can help patients with Tardive Dyskinesia to better manage symptoms. Doctors treating Tardive Dyskinesia patients may know about new drugs that may counter the side effects of Tardive Dyskinesia. Fro example, TARVIL, a medial food, has been documented to be useful in the treatment of Tardive Dyskinesia for male patients, according to a study published in the American Journal of Psychiatry, June 2003.
Personal injury attorneys may also evaluate the circumstances surrounding your case to help ensure that you receive adequate compensation for your condition. Tardive Dyskinesia lawsuits will not be initiated until cases are thoroughly evaluated by personal injury attorneys, but Tardive Dyskinesia patients may be awarded financial compensation to assist in managing their losses due to Tardive Dskinesia.
