Reglan Black Box Comes Nearly 30 Years Too Late

Washington, DCWhen the US Food and Drug Administration (FDA) mandated a Black Box warning for Reglan, patients who have already experienced adverse reactions to the drug would not have been surprised.

Reglan is the commercial name for the drug metoclopramide, a drug made by a number of generic manufacturers for the treatment of gastrointestinal disorder (GERD) and Gastroparisis, among other symptoms. A so-called motility drug, Reglan aids the movement of food through the digestive tract.

It's been around for awhile too, having been first approved by the FDA in 1980.

The black box warning is primarily directed at one of the most serious and potentially irreversible side effects: Tardive Dyskinesia (TD), and the relationship between this unfortunate condition and the consumption of Reglan, at high doses, for long periods of time.

The latter is defined as three months or more. The Black Box Warning for Reglan indicates the greatest risk for the short, or long-term development of TD remains with the elderly and elderly women in particular.

The woman who posted to a Reglan message board in February of this year did not give her name. However, she lists her age as 64 and notes she has taken Reglan for 4 months—longer than the recommended cut-off for Reglan in order to maximize safety. As the woman makes reference to chemotherapy, it is assumed she is a cancer patient and was most likely prescribed Reglan for nausea.

"I have developed a disease known as Tardive Dyskinesia, which is linked to the drug Reglan (Metoclopramide)," she writes. "On February 27, 2009, the FDA issued a 'Black Box' warning for this drug, and says it is linked to the Dyskinesia syndrome.

"After taking the drug to combat nausea during chemo, I started developing problems with my mouth and tongue, with the primary problem being my tongue. It felt like my tongue was contorted, and I was constantly moving my tongue.... all the time. Over the five months since stopping the drug, this problem still persists and I have also developed rapid eye twitching and constant anxiety feeling. In discussing with my oncologist, he says this has been linked to the drug Reglan.

"I would highly recommend that before taking this drug you research for yourself…this is a nasty drug. The symptoms are not treatable and can be permanent."

Other Reglan patients have complained of anxiety, panic attacks or tremors, together with a constant compulsion to 'keep moving.' Some have reported depression.

However TD remains a major concern as it can, in some cases become permanent. The potential for the onset of permanent TD can have grave effects on an individual's ability to function on the job, given that TD involves involuntary movements. The latter can make operating heavy machinery dangerous. Anyone involved in a career that puts them in the public eye could have their livelihoods threatened. Imagine a television news anchor suddenly beset with permanent TD, the result of simply taking a medication? The involuntary movement of the tongue and eyes for someone constantly under the spotlight could easily translate to career death.

"Recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders," cites the FDA. "Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used metoclopramide took it for longer than three months. The FDA has also become aware of continued spontaneous reports of Tardive Dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than three months."

The Black Box warning serves to alert both physicians and the general public with regard to the risks inherent with Reglan and TD. However, this warning comes nearly 30 years after Reglan was approved. If you have developed permanent, or even temporary TD and have a history of taking Reglan, you would be well advised to seek legal advice.