UPDATE NOVEMBER 2008
Elizabeth Conte took generic Reglan for four years and developed debilitating, permanent, tardive dyskinesia. Because generic manufacturers do not produce literature about their product, her doctor had relied in literature produced by Wyeth Pharmaceuticals which makes the name brand Reglan. This includes the descriptions of side effects that Wyeth supplied for the Physician's Desk Reference and the package insert that comes with both name brand and generic versions of the medication.
In a complicated trial and series of appeals, the ruling appears to be that Wyeth was negligent for underrepresenting the dangers of the medication.
Are the medicines safe for my baby?
[This article first appeared in the PAGER newsletter, Reflux Digest, June 2005]
This document has been reviewed by the medical team at www.HealthCentral.com
This is one of the most common questions we are asked. Fortunately, it appears as though most medications used to treat GER are reasonably safe and have few side effects. Motility medicines are an exception and are known for frequent side effects, some of which are serious. The article attached at the bottom of this page has further details about motility medication side effects. In January 2009, the Food and Drug Administration issued a Black Box Warning for the most popular motility medication, Reglan
An equally important question may be "What are the long term effects of not medicating a child with significant reflux?"
Untreated or poorly treated reflux has the potential to be very dangerous. Untreated pain in babies can make them withdraw from the world and develop very unhealthy attitude toward eating. Some even become afraid of food. Asthma can be caused by reflux. Patients with asthma and their families often don't realize that asthma can be deadly. Children with acid reflux who have respiratory symptoms may need more aggressive treatment to prevent lung damage or apnea.
When you are making decisions about safety, you should consider that not treating reflux may be the more dangerous course of action.
Data on long-term use of medications in children is still being gathered. The initial studies done on any medication are those conducted by the pharmaceutical companies to get FDA approval. With most of the reflux medications, companies only studied short-term use in adults and the studies were not huge. Once a medicine is on the market, the FDA tracks complaints and reports of problems although there is a good deal of debate about how well they do so.
Most of the current medications have been in use for 15 years or longer in adults and have a pretty good track record. We will have to wait to see what develops.
At PAGER, we are almost more concerned that scientists will learn in the future that there are some health issues that arise from a chronic lack of acid. But at the moment, we don't really have any other options and it isn't fair to let a child suffer in excruciating pain in the hopes that some better options will come along. Medicine is a constantly evolving science. What we think we know now may be laughable in a decade. But your child's life may be intolerable without medications. You have to make the best decisions you can with the information that is available NOW.
On a positive note, a few of the GER medications have recently been tested in children. Many other pharmaceutical companies are also working towards getting their pediatric approval from the FDA which is good news for everybody.
The staff of PAGER recently wrote a review article on Reglan (metoclopramide) and tardive dyskinesia that was published in the journal Practical Gastroenterology in May of 2004. Click below to read the text.
If you have witnessed a bad reaction to a medicine, please report it to the MedWatch program at the FDA. They don't require proof, just report what you saw. You can even report a problem years after it happened.
Additional Information added in 2006:
The FDA has a web site where you can track changes to the pediatric dosing, age and safety recommendations. Did you know that Famotidine doses in infants were lowered? http://www.fda.gov/cder/pediatric/labelchange.htm