Reglan: New Warnings from the FDA 3/2/09
The FDA has issued a new warning about the use of Reglan or Metaclopramide, a medication that may be used to treat Gastroesophageal Reflux Disease (GERD) and related conditions. There has been ongoing concern about the side effects of Reglan. Some children and adults experience Tardive Dyskinesia including tremors and involuntary movements. The new warnings offer more specific information on how the medication should be used.
If you are a parent of an infant or child on Reglan or if you are holding a prescription for Reglan, I know you will have many questions and concerns.
I have put together a list of the common questions parents have about Reglan and the new FDA warning.
What is Reglan?
Reglan is a motility medication. It works by helping food move faster through the digestive tract. Reglan may be used to treat GERD and Gastroparisis.
What is a “Black Box” warning?
The Food and Drug Administration (FDA) oversees the safety of all medications used in the United States. Sometimes the FDA issues a warning to doctors and consumers to warn of specific side effects or drug interactions that may make a particular medication less effective or harmful. A Black Box warning is the most serious warning issued by the FDA indicating that particular care needs to be taken when deciding to use the medication.
Why did the FDA place new warnings on Reglan?
There is new concern that long term use (more than 3 months) of high doses of Reglan may lead to short term or permanent Tardive Dyskinesia symptoms. The FDA believes the greatest risk for side effects is in the elderly and elderly women in particular.
Keep in mind that the warning does not say Reglan should not be used at all. It is clarifying that it should be used with great care at the lowest possible dose and for short term use only.
What should I do if my baby or child is on Reglan?
Most importantly, do not stop Reglan abruptly. If you consult the doctor and determine that your child should stop taking Reglan, ask the doctor how to wean off of the medication slowly to avoid side effects from stopping the medication too quickly.
Second, don’t panic. Many, many infants and children have used Reglan with a significant reduction in vomiting and other symptoms of reflux. If your child is tolerating the medication without side effects and benefiting from this treatment, there is no need to panic.
Third, it is very important to work closely with your doctor when using Reglan. Ask the doctor to give you detailed information about the side effects of Reglan and to describe Tardive Dyskinesia. The pharmacist is also a wonderful resource for this information. Further, be sure to ask the doctor if your child is on the lowest possible dose and monitor the effectiveness of the treatment. The doctor may be able to suggest alternate treatments after the 3 month period is over or you and the doctor are concerned about using Reglan.
What alternative treatments are available?
Work with your doctor to identify the specific symptoms that are worrisome and find alternative treatments.
Vomiting: Try thickened feedings, small, frequent feedings and holding upright after a meal.
Slow Digestion: Try a low fat, high fiber diet, treat constipation, and eat small, frequent meals.
Erythromycin is sometimes used as an alternative to Reglan. Other medications that may be used are: Baclofen, Propulsid, Domperidone and Bethanachol. Not all of these medications are in use in the United States. Propulsid was taken off the market by the FDA several years ago. At present, there is a great need for a safe and effective treatment for motility and GERD.
Remember that every child is different and there is no “one size fits all” treatment for GERD. Everyone reacts to medications differently. My daughter had an amazing response to Propulsid but others have had serious and even life threatening side effects. She used Reglan for a short period of time and I found that she had unpleasant side effects and the medication didn’t help her symptoms so the medication was stopped. I know of many success stories with Reglan and also some worrisome side effects from using Reglan. Let me know your experiences with Reglan or what alternatives you have found for treating GERD.