Reglan – FDA Warning

Metoclopramide, a treatment for various stomach and digestive disorders, was first developed in Europe in 1964. Gastroparesis (partial paralysis of the stomach) and symptoms associated with acid reflux disease (primarily heartburn) are conditions where metoclopramide has been used for treatment. Since 1982, it has been available as a generic drug and has been marketed under the trade names Maxolon and Reglan, among others.

Historical Background

In the 1990s, metoclopramide fell out of favor as doctors began turning to a new product known as Cisapride, which was developed by the same Belgian pharmaceutical company responsible for the discovery of several antipsychotic, or "neuroleptic" dopamine antagonist (inhibitor) medications during the late 1950s and 1960s. These were used primarily for the treatment of schizophrenia; although this was not the case with Cisapride. The dopamine antagonist mechanism was found to be effective in the treatment of various digestive disorders.

By 1999, Cisapride was found to cause heartbeat irregularities among certain patients. Six months following the issue of an FDA warning, the drug was withdrawn from the market for human consumption, although veterinarians still use it to treat hairballs in domestic felines. Because metoclopramide was an older, "more established" medication, doctors began using it again for the treatment of gastrointestinal problems.

In 2004, a research team in Maryland published their findings in the Journal of the American Pharmacists Association, concluding that the use of metoclopramide may lead to the development of symptoms associated with tardive dyskinesia, particularly among women and the elderly. However, it took four more years for the Food and Drug Administration to issue regulations that required the manufacturers of Reglan and others to place warnings on the package.

Approval and Warnings

The FDA states that metoclopramide is "approved for the short-term (no longer than 3 months) treatment of gastrointestinal disorders," but warns that "frequent and long-term use of metoclopramide has been linked to tardive dyskinesia," stating that older women are at the greatest risk for developing symptoms. It is recommended that patients discuss the medication with their physicians and it should not be used for more than 90 days unless the doctor's assessment determines that "the benefits outweigh the risks."

Patients are further warned that symptoms of tardive dyskinesia may be permanent and the chances of symptom reversal diminishes as dosage amount and length of time the medication is taken increases. In the meantime, approximately two million patients in the U.S. continue to be treated for symptoms of acid reflux disease with Reglan.

Is There an Alternative?

In many cases, symptoms of acid reflux disease are related to diet. There some anecdotal evidence to suggest that certain genetically-modified foods may be to blame, particularly GMO corn products such as tortilla chips. Some have claimed that switching to certified organics has addressed symptoms of acid reflux. Others report that drinking unfiltered organic apple cider vinegar every day may improve digestive function and eliminate symptoms of acid reflux.

Alternative medications include Prilosec, Prevacid or Nexium. These are a class of "proton pump inhibitors" which prevent the stomach from producing acid. While these can be effective in controlling the symptoms of acid reflux, they do not cure the condition and long-term use can compromise the immune system. Additionally, these medications become less effective over time and there is evidence that long-term use of these medications can make older patients more susceptible to hip fractures.

It should also be noted that "over-the-counter" antacids such as Rolaids or Tums are for occasional use and only relieve symptoms. They do not address the underlying causes of acid reflux disease.

Sources

Associated Press. "FDA Slaps Warning on Heartburn Drug Tied to Spasms" Baltimore Sun, 26 February 2009.
Associated Press. "Heartburn Drugs Tied to Hip-Fracture Risk." MSNBC News, http://www.msnbc.msn.com/id/16358462/ , 29 December 2006.
Collins, Irene. "Metoclopramide Causes Tardive Dyskinesia." Science/Health News, 1 March 2009.
Shaffer, Douglas et. al. "Tardive Dyskinesia and Metoclopramide Use: Effects of Cisapride Market Withdrawal." Journal of the American Pharmacists Association vol. 44 no. 6 (2004).