NEWS: 2/27/2009 FDA Warning for metoclopramide Reglan Tablets

FDA notified healthcare professionals 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. These symptoms are rarely reversible and there is no known treatment. 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. Manufacturers will be required to implement a risk evaluation and mitigation strategy [REMS] to ensure patients are provided with a medication guide that discusses this risk. Current product labeling warns of the risk of tardive dyskinesia with c hronic metoclopramide treatment.
Read the MedWatch 2009 safety summary, including a link to the FDA News Release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Metoclopramide

Reglan side effects:

Seek medical help as soon as possible if you have any of these signs of an allergic reaction to Reglan or other metoclopramide products: hives; difficulty breathing; swelling in the face, lips, tongue, or throat area.

Stop using Reglan other metoclopramide products and call your doctor at once if you have any of these serious side effects or indications of tardive dyskinesia:

Restless muscle movements in either the eyes, your tongue, jaw, or neck; tremors.

Appearance of the face being “mask-like”.

Uneven heartbeats, rapid breathing, fever, stiff muscles, confusion or sweating.

Thoughts of suicide or hurting yourself or a overall depressed mood.

Hallucinations, anxiety, agitation, jittery feeling, trouble staying still.

Jaundice – yellowing of your skin or eyes.

Seizure and or convulsions.

If you’ve been hurt or injured from taking either Reglan Tablets or any other  metoclopramide based drug – fill out this form for a free case review.