You would know TD to see it - involuntary movement of facial muscles, most often seen amongst the senior population, but not exclusively. Anyone, at any age can become afflicted with TD, and Reglan is a known link. It even says so in the product literature.
Reglan is Metoclopramide, a drug that, according to Bill Sardi writing on the Knowledge of Health web site, inhibits and blocks dopamine receptors in the brain, kidneys and the peripheral nervous system. Approved by the U.S. Food and Drug Administration (FDA) for short-term use and prescribed for the conditions noted above, some of Reglan's side effects can be debilitating.
'Jenelle' knows all about it. Prescribed Reglan to control her vomiting after contracting food poisoning, the young woman from Indiana was almost immediately exhibiting the involuntary movements associated with Tardive Dyskinesia. Vibrant in her early twenties Jen was, sadly, misdiagnosed and administered a host of neuroleptic drugs, which only served to worsen her condition.
She's off all those drugs now - but not before they put her in a wheelchair, the drug cocktail having succeeded in damaging the part of her nervous system linked to motor control. Jenelle suffers from Dystonia, and while she is enjoying life as a new wife and mother, and studying for her PhD in Neuroscience at Indiana University, Jen's disability is permanent.
Part of the problem with Reglan - or more correctly, with the physicians writing the prescriptions - is that 30 per cent of patients taking Reglan have been on the drug for a year or more, and much longer than the 4 to 12 week parameter under which it was initially approved by the FDA. And while Tardive Dyskinesia can occur at any time within the drug cycle, the longer a patient is on Reglan the greater the possibility of developing the involuntary dysfunction that can last a lifetime.
While the labelling does refer to the possibility of Tardive Dyskinesia as a potential side effect, the manufacturer claims that its appearance is rare. And yet two studies have found that 27 - 29 per cent of long-term users of Reglan have developed Tardive Dyskinesia.
In their book; 'Your Drug May Be Your Problem: How and Why to Stop Taking Psychiatric Drugs', psychiatrist Peter Breggin, M.D. & professor David Cohen, Ph.D. claim that "...rates of TD [tardive dyskinesia] are extremely high. Many standard textbooks estimate a rate of 5% - 7% per year in healthy young adults. The rate is cumulative so that 25% - 35% of patients will develop the disorder in 5 years of treatment," with neuroleptic drugs, into which Reglan is classed. (Perseus Books, 1999, p. 78). "Most elderly patients, treated [with neuroleptics] for only two or three months, develop obvious, irreversible twitches or spasms; they risk dementia as well" (ibid., p. 104).
Another adverse affect - and one identified in the product labelling but not highlighted by any black box warning, is the potential for the onset of Neuroleptic Malignant Syndrome (NMS), a condition identified as rare in the product labelling, but is nonetheless often fatal. Symptoms include high fever, sweating, unstable blood pressure, stupor, muscular rigidity and autonomic dysfunction; these can appear within the first 2 weeks of taking the drug.
READ MORE LEGAL NEWS
On this topic, lawyer Jerry Spence doesn't mince words. In his book With Justice for None, Spence slams the regulatory environment that allows a drug like Reglan, with such potential for devastating adverse affects on human health, to remain on the market.
"If we have learned anything from nearly a century of government regulation, it is that the administrative agencies of government are almost invariably captured by the industries they are created to regulate"
Reglan is manufactured by Schwarz Pharma Inc., and approved by the FDA for short-term use only.