Reglan Tardive Dyskinesia Lawsuits
FDA WARNING POINTS TO DANGERS OF LONG-TERM USE OF REGLAN; TWO MILLION AMERICANS WITH REFLUX DISEASE COULD BE AT RISK
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For years, reports mounted of an untreatable, irreversible movement disorder among patients taking Reglan (metoclopramide) on a long-term basis. In February of 2009, the Food and Drug Administration finally took action, and required manufacturers of Reglan and generic metoclopramide to add a “black box” warning to the labeling with regard to the drug’s link to tardive dyskinesia.
Sadly, however, the warning is the equivalent of “shutting the barn door after the horse is out” for some two million unsuspecting Americans taking Reglan and generic
metoclopramide products for gastroesophageal reflux disease (GERD). Many of them are experiencing repetitive, involuntary movements of their arms and legs, lip smacking and other mouth and lip movements, rapid blinking, or diminished movement of their fingers.
The brand name Reglan and its generic equivalent metoclopramide are marketed to relieve gastroesophageal reflux disease (GERD) in patients who have not responded to other therapies. The drugs are also used to treat delayed gastric emptying which may be associated with conditions such as diabetic gastroparesis and for post-operative nausea and vomiting. Reglan works by increasing the movement of stomach muscles, which speeds up the rate at which the stomach empties into the intestines.
The FDA has determined that a significant number of Reglan and metoclopramide drugs have been sold to patients to treat chronic conditions on a long-term basis. But this drug has never been approved by the FDA for use on a long-term basis (more than 12 weeks), since there is insufficient safety data to support long-term use, and strong evidence that long-term use of Reglan increases the risk of developing tardive dyskinesia.
Current studies indicate that Reglan and generic metoclopramide have become the most common cause of drug-induced tardive dyskinesia, especially in patients who ingest the drugs beyond the 12-week limit set forth in the labeling. As a result of this research, the FDA concludes that the development of tardive dyskinesia is “directly related to the length of time a patient is taking metoclopramide and the number of doses taken.”
There is no treatment or cure for tardive dyskinesia. While stopping the Reglan may relieve some symptoms in some patients, in other patients the symptoms of tardive dyskinesia actually worsen when Reglan is discontinued. Its victims, both adults and small children, are left asking how manufacturers could have failed to adequately investigate the safety of Reglan, to inform the public and physicians of the significant risks associated with long-term use of the medications for chronic conditions, and to provide warnings to the public regarding potential side effects that have been identified as early as 1995.
Lawsuits have been filed against the manufacturers of Reglan and generic metoclopramide alleging that the drug companies and their sales representatives knew about and encouraged the long-term prescription of these medications to patients with chronic conditions . . . despite the lack of data to support the safety of long-term use of the medications and the fact that long-term use had not been approved by the FDA.
At Searcy Denney Scarola Barnhart & Shipley, we have more than 30 years of experience representing clients harmed by dangerous pharmaceuticals.
Our attorneys understand the physical and emotional toll on patients and families, and their bewilderment, when a drug prescribed to alleviate one medical problem results in a life sentence of suffering from another, far worse condition. We have earned a reputation for meticulous investigation, thorough preparation, and aggressive pursuit of justice for our clients.
If you or a loved one has suffered the symptoms of tardive dyskinesia as a result of taking Reglan or metoclopramide, please fill out our Contact Form, or call us to learn more and arrange for a confidential free consultation.
What is metoclopramide?
Metoclopramide is a drug used to increase muscle contraction in the upper digestive tract. The contraction of the digestive tract speeds up emptying of the stomach and aids in minimizing gastroesophageal reflux (GERDS) and slow gastric emptying in diabetics, which is called diabetic gastroparesis. This drug is included in Reglan, Octamide and Maxolon.
Metoclopramide was intended to be used in small doses and for short durations. The inclusion in the drug Reglan and the subsequent complications, including Tardive Dyskinesia, should have been predictable considering the known complications of metoclopramide:
- tremors, or restless muscle movements in your eyes, tongue, jaw, or neck;
- mask-like appearance of the face;
- fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing;
- depressed mood, thoughts of suicide or hurting yourself;
- hallucinations, anxiety, agitation, jittery feeling, trouble staying still;
- swelling, fluid retention;
- jaundice (yellowing of your skin or eyes);
- seizure (convulsions)
- feeling restless, drowsy, tired, or dizzy;
- headache, sleep problems (insomnia);
- nausea, diarrhea;
- breast tenderness or swelling;
- changes in your menstrual periods;
- urinating more than usual.
What is Tardive Dyskinesia?
Tardive dyskinesia was first diagnosed in the 1960’s and has been commonly linked to use of metoclopramide.
Tardive dyskinesia is a condition in which people develop involuntary muscular movements or difficulty in performing voluntary muscle movements. The actual condition of tardive dyskinesia can often manifest long after discontinuation of the medication causing it. Tardive dyskinesia demonstrates similar to diseases such Parkinsons, dystonia, Tourette’s and other similar conditions.
Tardive dyskinesia results from damage to systems in the body that use or process dopamine. Dopamine acts as a neurotransmitter in the human brain to regulate body movement and emotion in the body. When dopamine is blocked or not well regulated, it remains in the synapses in the brain; synapses are used for regulation of neurotransmission for receiving and transmitting signals from the brain to the body and to the brain. When neurons in the brain can no longer maintain the volume of dopamine, Parkinson-like symptoms manifest and this is thought to be the genesis of tardive dyskinesia.
What is the treatment for Tardive Dyskinesia?
Sadly, the curative treatments for tardive dyskinesia are not available. The palliative treatments for it are drugs used to treat parkinsonian symptoms. Tetrabenzine, Aricept, and Miraplex have demonstrated efficacy in relieving symptoms.
Unfortunately, the diagnosis of tardive dyskinesia is sometimes missed by physicians and, as a result, some patients may have to undergo treatment, which is not helpful to their condition.
What have regulatory agencies done?
In February of 2009, the FDA ordered manufacturers to issue a “black box warning” on all medications containing metoclopramide, including Reglan:
FOR IMMEDIATE RELEASE
Feb. 26, 2009FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs
Agency warns against chronic use of these products to treat gastrointestinal disorders
The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.
Manufacturers will be required to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.
The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment, said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.
Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.
Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
Metoclopramide works by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines. It is used as a short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies, and to treat diabetic gastroparesis (slowed emptying of the stomach's contents into the intestines). It is recommended that treatment not exceed three months.
Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products.
Recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders. Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used metoclopramide took it for longer than three months. The FDA has also become aware of continued spontaneous reports of tardive dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than three months.
Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20852-9787, or online.
Our attorneys understand the physical and emotional toll on patients and families, and their bewilderment, when a drug prescribed to alleviate one medical problem results in a life sentence of suffering from another, far worse condition. We have earned a reputation for meticulous investigation, thorough preparation, and aggressive pursuit of justice for our clients.
If you or a loved one has suffered the symptoms of tardive dyskinesia as a result of taking Reglan or metoclopramide, please fill out our Contact Form, or call us to learn more and arrange for a confidential free consultation.
Related Links:
Drug side effect mistaken for Parkinson’s disease - Reglan
FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs