FDA MedWatch – 2009 Safety Alerts for Human Medical Products

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:

1. Reglan Tablets
2. Reglan Oral Disintegrating Tablets
3. Metoclopramide Oral Solution
4. 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

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