Reglan Tardive Dyskinesia Warning by FDA
March 7, 2009 by Jay Genkins
Filed under Consumer Alerts, FDA
FDA MedWatch – 2009 Safety Alerts for Human Medical Products
Metoclopramide-Containing Drugs
The FDA announced today that the side effects from metoclopramide, ( a main ingrediant in many Reglan products) and a Gastrointestinal Medication, should be warned of a very serious disorder called tardive dyskinesia.
The FDA alerted healthcare officials that makers 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.
Metoclopramide usage of a long period of time has been linked to tardive dyskinesia, which can include involuntary and repetitive movements of the body. Even if you have not taken the drug for a while it sometimes can still occour.
The symptoms are often if not almost never reversible and there is no known treatment.
Metoclopramide is available in a variety of formulations including tablets, syrups and injections.
The Makers will be required to use a risk evaluation and mitigation strategy [REMS] to make sure that patients are provided with a medication guide that discusses this risk.
Makers include Baxter International Inc (BAX.N) and several generic drug companies.
More than 2 million Americans use the medicines to treat gastroesophageal reflux disease and other stomach ailments, the FDA said.
Products that commonly contain metoclopramide:
- Reglan Tablets
- Reglan Oral Disintegrating Tablets
- Metoclopramide Oral Solution
- and Reglan Injection
According to Watergate Summer Whistle Blower,Mom and Nurse; “Many people take this med for Reflux and GI Ulcer symptoms and take for long periods of time.”
What is tardive dyskinesia?
Tardive tourettism is a tic disorder that can closely mimic Tourette Syndrome, sometimes to the point where the two can only be distinguished by the details of their onsets.
Tardive dyskinesia is a variety of dyskinesia (involuntary, repetitive movements) manifesting as a side effect of long-term or high-dose use of dopamine antagonists, usually antipsychotics. Other dopamine antagonists that can cause tardive dyskinesia are drugs for gastrointestinal disorders (e.g. metoclopramide) and neurological disorders.
Video: The Treatment of Tardive Dyskinesia with … MORE Drugs!
Other Drugs that can cause tardive dyskinesia are mainly antipsychotic medications and include:
- Thorazine (Chlorpromazine)
- Clozaril (Clozapine) (may also treat the condition)
- Haldol (Haloperidol)
- Seroquel (Quetiapine)
- Loxitane / Loxapac (Loxapine)
- Mellaril (Thioridazine)
- Navane (Thiothixine)
- Prolixin / Modecate (Fluphenazine)
- Piportil (Pipotiazine)
- Trilafon (Perphenazine)
- Orap (Pimozide)
- Stelazine (Trifluoperazine)
- Risperdal (Risperidone)
- Serentil (Mesoridazine)
- Zyprexa (Olanzapine)
Some of the non-neuroleptic drugs that may also cause tardive dyskinesia are:
- Prozac (Fluoxetine)
- Zoloft (Sertraline)
- Nardil (Phenelzine)
- Elavil (Amitriptyline)
- Asendin (Amoxapine)
- Sinequan (Doxepine)
- Tofranil (Imipramine)
- Lithium
- Cocaine and other street drugs
Symptoms of Tardive Dyskinesia
Tardive dyskinesia is characterized by repetitive, involuntary, purposeless movements such as:
- Fine, worm-like movements of the tongue
- Lip smacking
- Chewing or sucking movements
- Grimacing (making faces)
- Puckering or pursing the lips
- Tongue protrusion
- Rapid eye blinking
Thanks to about.com for this list
A Very Detailed Article about Tardive Dyskinesia on Medscape
Defective Drug News
Othe Resource: Soulful Sepulcher
Technorati Related: health, tardive, dyskinesia, reglan, side, effects, disorders
