What is Reglan® | Reglan's Black Box Warning | Off-Label Uses
Alert for Pregnant Women & Nursing Mothers | Alert for Migraine & Cluster Headache Victims
More Warnings Needed on Reglan Side Effects

Off-Label Uses of Reglan®

Metoclopramide is frequently prescribed for uses not approved by the FDA.  This “off-label” use of Reglan has the potential to put many others at risk of developing tardive dyskinesia.

"The label says that the drug passes through breast milk, but it has not been proven safe for the baby when the mother is given Reglan to increase her milk supply."  Roger Drake, Baum Hedlund attorney -- Read the Article

Pregnant women:
Reglan® is sometimes given to pregnant women for the treatment of morning sickness although this use has not been approved by the FDA. Physicians prescribe metoclopramide to pregnant women in order to treat severe morning sickness even when the risk to the unborn child is not yet known. A study published in the New England Journal of Medicine in June of 2009 has claimed that Reglan® is safe for the treatment of severe morning sickness during the first trimester of pregnancy. The article, however, fails to mention anything about the risk of tardive dyskinesia or the black box warning (which was added to metoclopramide’s label three months before the article was published).



Nursing mothers:
Reglan® has also been prescribed off label to nursing mothers for its ability to stimulate milk production by aiding the release of the hormone prolactin. Metoclopramide’s medication guide, issued in connection with the black box warning, acknowledges that “REGLAN® is passed into human milk and may harm your baby.”

Migraines and cluster headaches:
One off-label Reglan® use is the treatment of nausea and vomiting caused by migraines and cluster headaches. Reglan® is commonly taken in conjunction with migraine pain medication since it may help the body better absorb these medications. Also, by preventing a patient from vomiting, it has the ability to ensure the pain medication gets absorbed.

Partial List of Companies that Manufacture Metoclopramide

  • A.H Robins Company, Inc.
  • American Home Products Corporation
  • Wyeth Pharmaceutical, Inc.
  • Robins
  • Baxter Healthcare Corp
  • Alaven Pharmaceuticals
  • ESI Lederla Genetics
  • CFL
  • Schwartz Pharma, Inc.
  • Teva Pharmaceuticals, Ltd.


Related Links
FDA Press Announcements
National Library of Medicine:  Tardive dyskinesia
LA Times
Reglan Side Effects in Infants

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What is Reglan® | Reglan's Black Box Warning | Off-Label Uses
Alert for Pregnant Women & Nursing Mothers | Alert for Migraine & Cluster Headache Victims
More Warnings Needed on Reglan Side Effects