Why the manufacturers of Reglan (metoclopramide) need to pay up

You might have seen the notices in the papers or the ads on TV. It's a familiar sight. Personal injury law firms circling like vultures around pharmaceutical companies because some people might have adverse effects from a popular drug. It seems like another form of ambulance chasing, doesn't it?

I used to think so.

Reglan (metoclopramide) is a drug commonly used as an antiemetic, in patients with delayed gastric emptying, and far too often an all purpose panacea for all things gastrointestional. Most people usually only need a few doses. However, those with chronic GI problems, the drug has been prescribed for months, even years.

Therein lies the problem.

The manufacturers have failed to inform healthcare professionals and patients that the drug shouldn't be used for longer than 12 weeks. Well, actually, that was true until February of this year, when the FDA required that the drug carry a black box warning. This warning stated the risk of "tardive dyskinesia" in long term use or high doses.

Black box warnings seem like something we see in some newer drugs where not enough time has passed to see any long term implications of using the drug. What makes this particular black box warning especially frustrating is that the manufacturers knew of the risk of tardive dyskinesia with long term use OVER 20 YEARS AGO.

The first suit filed over Reglan and its adverse effects went to court in 1989. And it has hardly been a rare occurence. So why has it taken over 20 years for the manufacturers to inform the medical community and patients of this risk? The drug's patent was protected until 1982. This means the original manufacturer no longer had a proprietary interest in it because other pharmaceutical companies could make a cheaper, generic version of the drug.

Whatever the reason, these 20 years of knowing, yet not informing the public of the drug's potential risks has been devastating to some patients.

Tardive dyskinesia is a disorder in which the patient experiences repetitive, involuntary movements like grimacing, tongue protrusion, lip smacking, puckering and pursing of the lips, and rapid eye blinking. Rapid movements of the extremities may also occur. Impaired movements of the fingers may also appear.

TD is usually seen as a consequence of long term use of antipsychotic drugs and neuroleptic drugs such as antiseizure medications. And now we know, Reglan. The difference is that many doctors who are presented with a patient exhibiting TD can usually figure out the culprit right away. TD caused by Reglan is often being diagnosed as a Parkison type disorder and consequently, is not treated properly. This results in continued use of the Reglan which results in symptoms that worsen with time which results in continued misdiagnosis and treament, making it a vicious cycle.

If the Reglan is discontinued soon after symptoms appear, recovery from TD is good. Unfortunately, if it is not, the TD can be permanent and often worsens even after the drug is stopped.

This is exactly what has happened to my mother. She had been on Reglan since 2002 after surgery for stomach cancer. Because of the lack of warnings, when she displayed TD symptoms, Reglan as the cause was missed. She continued the drug for over a year after her symptoms started. By the time these black box warnings were brought to the forefront, it was too late for her. She will likely never recover from TD.

Here is a video showing some patients with TD. As you can see, TD isn't just a disorder of annoying tics, it's something that can be and is debilitating for some. My mother and countless others like her are victims of neglect by the manufacturers of the drug. And because of this, they should pay up.