Black Box Warning Due for Reglan

March 24, 2009. By Gordon Gibb

Washington, DC: They may have known about it for years, but the US Food and Drug Administration (FDA) is finally getting around to mandating a black box warning for Reglan side effects—and specifically, Reglan tardive dyskinesia. Metoclopramide side effects can be either temporary, or permanent. The latter could have life-changing effects on a patient's health and well-being.

Reglan is prescribed to treat various gastrointenstinal disorders, including but not limited to the slow stomach emptying that can occur in tandem with diabetes. Reglan has also been pressed into service as a second-line treatment for heartburn stemming from gastroesophageal reflux. Migraine headaches, as well as the nausea and vomiting often associated with treatment for cancer, are other conditions where Reglan is used.

The problem is that metoclopramide—which is what Reglan is—works by blocking dopamine in the brain. And therein lay the risk for any drug that targets the neurological system. When you mess with the brain, there could be some nasty side effects.

Such is the case with Reglan, and for that matter other manufacturers that make metoclopramide. The key metoclopramide side effect is tardive dyskinesia (TD), and has been described as a 'horrible' condition characterized by involuntary, and unnatural movements of the mouth, tongue and jaw. The face (uncontrollable jerking) and eyes (blinking) can also be affected, as can other areas of the body.

However the tongue, mouth and jaw appear to be the front-line respondents to TD, and the condition not only poses a problem for the patient with swallowing, it looks awful. Reglan patients working in retail, or in jobs that put them in close contact with other people, are at risk of being re-assigned, demoted or even fired due to their condition.

"Some people can get so bad it's hard for them to eat and swallow because of their tongue movements," says Dr. Jeff Bronstein of the David Geffen School of Medicine at UCLA. The neurologist adds, "…and obviously, cosmetically it's horrible."

Another neurologist, Dr. Joseph Jankovic at Baylor College of Medicine in Houston, studied hundreds of TD patients at his clinic over a 25-year span. He concludes that the longer a patient stays on metoclopramide, the greater the odds that TD will become a permanent condition that will not go away when the medication is stopped.

TD occurs in about 25 percent of all patients taking dopamine-blockers, including metoclopramide. Once TD is observed and diagnosed, Jankovic says, patients are taken off the metoclopramide and in some cases TD symptoms diminish.

"But in many cases, it becomes a permanent neurological disorder." No standard therapy exists, but various drugs have been used as treatments.

"It is a public health problem," Jankovic says. "Many of these patients who have metoclopramide-induced movement disorders aren't recognized until…they're at pretty advanced stages of the disease."

Jankovic is quick to point out that Reglan, and other metoclopramide drugs are effective for the intended uses—but only short-term. "But if the drug has to be used for longer than a few weeks, then I think it's prudent to switch the patient to these other drugs—even if they're less effective."

Enter the FDA, which has long been aware of the risk of TD when dopamine blockers such as Reglan are used. "We've known for years that tardive dyskinesia was a concern with this drug," says Rita Chappelle, a spokesperson for the FDA. "What we're trying to highlight in the box is the risk of chronic use."

Reglan was already labelled for short-term use, defined as 4 to 12 weeks. However a study by the FDA in 2007 revealed that 20 percent of patients were prescribed Reglan for longer periods of time.

Thus, the mandate for a black box warning alerting physicians to the increased risk for TD in patients prescribed Reglan for longer periods. The hope is that by alerting the medical community, and through them their patients regarding the risks of long-term use, the FDA will see a drop in the number of permanent cases of TD.

Until 2000, according to Dr. Jankovic, TD was associated primarily with Haldol, an antipsychotic drug. However over the last decade Jankovic has seen more cases of TD stemming from chronic use of metoclopramide (Reglan)—and since the latter "is prescribed by internists or gastroenterologists who are not necessarily familiar with the recognition of tardive dyskinesia," the FDA is correctly mandating a black box warning.

Some may argue, however, that it's a little late. And especially for those patients who have seen their lives turned upside down by the Reglan side effects associated with Reglan tardive dyskinesia. Metoclopramide side effects can be devastating. If you have become permanently disabled by TD in association with the long-term use of Reglan, it would be in your best interest to contact a Reglan side effects attorn

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