Reglan Tardive Dyskinesia: Why Are Patients On Reglan For So Long?

St. Louis, MOOf the various Reglan side effects, Reglan tardive dyskinesia is by far the most heartbreaking. But even more disturbing is the fact that while Reglan is recommended by the US Food and Drug Administration (FDA) for use not exceeding 12 weeks, there are patients who have been taking Reglan for a period of years.

The risk for developing tardive dyskinesia, which is the involuntary movement of facial muscles, the tongue and even limbs and appendages, heightens when the medication is taken for long periods of time.

Reglan Neurological Side Effects

On September 17th a reader of the St. Louis Post-Dispatch in Missouri crafted a question to a Q&A feature of the newspaper:

"A dear friend was put on Reglan for acid stomach and left on the drug for nine years. The therapy is only supposed to last a few weeks. She now has tardive dyskinesia. Her tongue is enlarged, and she can no longer speak properly. The side effects did not go away when the drug was stopped. Is there anything that can help her? Please warn your readers about Reglan."

The question was answered with a primer about metoclopramide. But the newspaper also took the FDA to task for waiting so long to add a black box warning to Reglan with regard to tardive dyskinesia, even though the FDA approved Reglan in 1980 and doctors were warned early on about Reglan.

Reglan Drug Side Effects

And that brings up another point about Reglan, and medications in general—the role that doctors play in the awareness of risks and adverse reactions inherent with most drugs.

There have been many examples of patients taking Reglan for a timeframe measured in years, not the recommended weeks. Part of the reason could be that Reglan is used to treat Gastroesophageal Reflux Disease (GERD), an ongoing condition often referred to as heartburn. When a patient is put on a medication that appears to work, patients and doctors are often reluctant to stop treatment. Coupled with a doctor's professional right to use a product beyond indications approved by the FDA, one can see how such situations can occur.

However it can prove a disadvantage for the patient who may not be aware of the long-term risks. This can put the patient at a disadvantage in states such as California, where a manufacturer's duty to warn of risks runs to the physician, not the patient. Thus the onus is on the doctor to respond to safety information on a product label and to ensure the patient is aware and understands.

All too often, that doesn't happen.