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Common drug causes spastic movements

-GreatFallsTribune

03/05/2009 - In a surprising move this week, the Food and Drug Administration announced that it is imposing the infamous "black box warning" on the label of a common gastrointestinal drug, metoclopramide or Reglan, because of serious side effects. To read the reports in the national press, one would think that this is a new discovery, that the diabolical forces of big pharma have once again pulled the wool over innocent doctors' and patients' eyes, and that, once again, the masked rider Uncle Sam is riding to our rescue on a white horse named Silver with the William Tell Overture playing in the background.

Meanwhile, those of us who have been around medicine for awhile are wondering where the FDA has been on this one. I have know about this side effect from my days in medical school.

So, just what is Reglan and how is it used?

Reglan, or metoclopramide as the generic is termed, belongs to a broad group of medications known as the phenothiazines. These are powerful drugs, the majority of which are heavy duty tranquilizers. Some are more powerful than others, used for the treatment of psychiatric disorders such as psychosis and schizophrenia. All of these medications are known to cause an ailment known as tardive diskinesia.

Tardive is often first seen in the facial muscles and can manifest as involuntary twitching at the mouth sometimes associated with tongue protrusions. In its most florid state it can be very disquieting and irreversible. In my experience, this side effect is far more common in the phenothiazines used in psychiatry and much less so in other medications used mostly in gastrointestinal medicine.

Many patients have problems emptying their stomachs or with reflux of stomach contents, including caustic hydrochloric acid, back up the esophagus. Having an agent that promotes emptying of the stomach in severe cases of diabetic gastroparesis (paralysis of stomach emptying) and severe reflux is a godsend. Significant numbers of these patients receive relief from chronic nausea and/or heartburn.

Of course, all drugs have side effects, and, as usual, the decision to prescribe these medications is made after determining that the benefit of the medication outweighs the risk.

Also, considering the fact that I clearly remember being taught about Reglan causing tardive in very small numbers of patients, I stand somewhat surprised that the FDA suddenly is making such a fuss. I graduated from med school in 1988 and can number my cases of tardive attibuted to Reglan on one hand. Furthermore, these were mostly reported as "allergies" to the medication, not observed cases.

 

This class of medications also can cause malignant hyperthermia. This is an unexpected very high fever, sometimes approaching 105 degrees, for which the antidote dantrolene must be given emergently. In fact fevers this high can be fatal, but dantrolene miraculously breaks the fever. When prescribing Reglan, I always mention fever and facial twitching as something to watch for with these medications. I explain to patients that the side effects are rare but are clearly reported in the medical literature and they need to stop the meds immediately if they experience these conditions or symptoms and notify me.

These conditions also can happen with phenergan, a common medication used for nausea, because, like Reglan, it derives from the family of phenothiazine drugs. Luckily, we have some alternatives to phenergan, but the list of prokinetic agents is very small.

Reglan is just about our only common agent for gastroparesis. In 2000, there was another choice, propulsid, or cisapride, which, unlike Reglan, is not a phenothiazine. However, it was reported to lead to irregular heart rythyms in some patients and the vendor, Janssen Pharmaceutics, pulled the drug from the market after enduring the bad publicity. Of course, we didn't worry too much back then because we still had Reglan available. Perhaps Propulsid will make a comeback.

Which brings me to a summary point. It strikes me as odd that common but rare side effects known to the medical, scientific and regulatory community for decades suddenly can become headline news, often brooking fear and loathing in the lay readership. ALL DRUGS HAVE SIDE EFFECTS! That is why most require a physcian's prescription and supervision for use.

So I encourage any reader who might be taking Reglan, or Phenergan for that matter, to discuss the use of the medications with your physician before stopping them, unless you are experiencing problems. And, in the future, be cautious about headlines which, on their face, seem designed to sensationalize news about medications.

If we have learned nothing else of late, it is that the national media often prints first, and, maybe, asks the discerning questions later. There are many people who need these drugs badly, and, tolerate them well. And that is a fact.