PAGER Association has received numerous complaints of movement disorders in children who take Reglan (metoclopramide). We have strongly urged anybody who sees a reaction to contact the FDA. Apparently, they have received a lot of reports. If you have seen problems, please report them to the US Food and Drug Administration by logging on to www.MedWatch.com or calling 1-800-FDA-1088.

Today, the FDA issued a statement requiring that the instructions for Reglan (metoclopramide) be printed with a Black Box Warning.

WARNING: TARDIVE DYSKINESIA
Chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. The elderly, especially elderly women, are most likely to develop this condition.

Metoclopramide therapy should routinely be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia; however, in some patients symptoms may lessen or resolve after metoclopramide treatment is stopped.

Prolonged treatment (greater than12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks to the patient of developing tardive dyskinesia.


See the FDA site for more information: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01963.html

It appears that the FDA is either considering or has approved an orally disintegrating tablet form of Reglan: http://www.fda.gov/cder/drug/DrugSafety/NDA%20metoclopramide%20REMS.pdf

You can read an article about the side effects of Reglan that was written by PAGER Board members Beth Anderson and Ed Freeman. Go to the Reading Room of this site and look at the Treatments section.

An article in Pediatrics reviewed the use of reflux medications by NICU's in 2003 and 2004. Some NICU's put over 90% of their premies on reflux medicines. Unfortunately, the authors did not state which reflux meds were most popular.http://www.ncbi.nlm.nih.gov/pubmed/18166553?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum