Off-Label Use of Reglan

Reglan Drug Injury

If a drug is prescribed off-label, it can mean that the drug is:

• used for a different disease or medical condition
• given in a different way (such as by a different route)
• given in a different dose than in the approved label

Off-label prescribing, also known as unapproved use, is the physician practice of prescribing a drug or medical device for a purpose different from one of the indications for which the product is approved by the Food and Drug Administration (FDA).

In Children

Reglan® is a drug that has often been prescribed for off-label use. Reglan, also known as metoclopramide, is not labled or FDA approved for use in children or infants, though it has been regularly prescribed to children and infants, particularly those suffering from gastroesophageal reflux disease (GERD). Reglan side effects in infants and children are more difficult to spot, which is another reason that off-label prescribing for this population is dangerous.

In Mothers

Nursing mothers have also been prescribed Reglan as a galactagogue, as an agent to increase milk production. Some women have been prescribed Reglan during their pregnancy either as a way to alleviate morning sickness to decrease gastric emptying time and assist in eliminating GERD.

If you or your child has taken Reglan for off-label uses, you need to be aware of your legal rights. Many lawsuits associated with Reglan and children have been filed. Contact Hughes & Coleman for a free online consultation regarding your Off-Label Use of Reglan.