reglan (Metoclopramide)- scary and dangerous or helpful and needed?

RMacLean
July 2006

 The mere word Reglan is capable of inciting fear in many. It is the center of much debate and controversy. But is all the controversy warranted? Well, yes and no.

So what is it about this silly little drug that can fuel such heated debates and has parents running in the other direction at its mere mention?

Reglan is the brand name of a drug called metoclopramide.[1] Metoclopramide stimulates motility of the upper gastrointestinal tract (…) Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter.

All that means is that reglan is a prokinetic or motility agent. It helps move food through the digestive system faster and helps to coordinate the muscles, essentially, making them work more effectively. This type of medication is used for reflux and GERD with the hope that moving through the digestive system faster will help to reduce reflux episodes. The idea is that the less time the food hangs around in the gut, the less chance it has to be refluxed. As well, frequently a high percentage of people with reflux or GERD will also have some degree of delayed gastric emptying so they would benefit from a drug that would enhance food transit time. Reglan is not; however, generally one of the first medications a doctor will reach for when treating infant reflux and GERD.

Now, why all the fuss? Reglan can, in some people, cause some pretty nasty, scary and potentially permanent side effects. It crosses the blood-brain barrier which can cause negative nervous system side effects. Metoclopramide is generally well tolerated when used in low doses for brief periods. The nervous system side effect risks usually increase with higher doses and longer periods of treatment. It is not meant for long term use and shouldn’t be used as such.

Medline describes the side effects of Reglan as follows:

[2]Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Rare
  • Abdominal pain or tenderness; chills ; clay colored stools; convulsions; dark urine; difficulty in breathing; difficulty in speaking or swallowing; dizziness or fainting; fast or irregular heartbeat; fever; general feeling of tiredness or weakness; headache (severe or continuing); inability to move eyes; increase in blood pressure; increased sweating; itching; lip smacking or puckering; loss of appetite; loss of balance control; loss of bladder control; mask-like face; muscle spasms of face, neck, and back; nausea and vomiting; puffing of cheeks; rapid or worm-like movements of tongue; shuffling walk; skin rash; sore throat ; stiffness of arms or legs; swelling of feet or lower legs; trembling and shaking of hands and fingers; tic-like or twitching movements ; twisting movements of body; uncontrolled chewing movements; uncontrolled movements of arms and legs; unusually pale skin; weakness of arms and legs; yellow eyes or skin

• With high doses--may occur within minutes of receiving a dose of metoclopramide and last for 2 to 24 hours
  • Aching or discomfort in lower legs; panic-like sensation; sensation of crawling in legs ; unusual nervousness, restlessness, or irritability

• Symptoms of overdose--may also occur rarely with usual doses, especially in children and young adults, and with high doses used to treat the nausea and vomiting caused by anticancer medicines
  • Confusion; convulsions (seizures); drowsiness (severe)

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Diarrhea—with high doses; drowsiness ; restlessness

• Less common or rare
  • Breast tenderness and swelling; changes in menstruation; constipation; decreased interest in sexual intercourse; inability to have or keep an erection; increased flow of breast milk; increased need to urinate; loss in sexual ability, desire, drive, or performance; mental depression; nausea; passing urine more often; skin rash; trouble in sleeping; unusual dryness of mouth; unusual irritability

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Another potential side effect is acute dystonic reaction which consists of involuntary, sustained, and often painful muscular spasms, producing twisting abnormal and/or rigid postures. These spasms are not to be confused with Sandifer’s Syndrome in which the child also exhibits abnormal posturing. Sandifer’s Syndrome is different in that the movements are completely voluntary and the child has complete control.

One such reaction is Tardive dyskinesia. [3]Tardive dyskinesia is characterized by repetitive, involuntary, purposeless movements. Features of the disorder may include grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye blinking. Rapid movements of the arms, legs, and trunk may also occur. Involuntary movements of the fingers may appear as though the patient is playing an invisible guitar or piano. The Reglan package inserts claim that this condition is a rare side effect; however, there are law firms currently filing suits against the manufacturers of Reglan claiming the incidents to be close to thirty percent of patients.

[4]Risk factors for TD include increased age, female gender, prolonged antidopaminergic drug exposure, presence of abnormal involuntary movements before drug therapy, diabetes mellitus, "organic" brain dysfunction and atrophy, and psychiatric disorders (e.g., schizophrenia, affective disorder, and alcohol abuse/dependence). Familial history is also associated with increased risks for metoclopramide-induced TD. Drugs implicated in TD in addition to metoclopramide include antipsychotic agents, antidepressants, central nervous system (CNS) stimulants, calcium channel blockers, and less frequently other drugs with CNS activity (for example, antihistamines, anticholinergics, and dopamine/serotonin antagonists).

So, is Reglan beneficial? For some people.

Does it have bad side effects? Potentially, for some people.

Is it the root of all evil in the medication world and to be feared and avoided at all costs? No.

Do all children with reflux or GERD need Reglan? No.

How do you know if you should you use Reglan for your child? That depends. It depends entirely on how severe your child’s GERD symptoms and complications are presenting themselves. As with anything, you have to carefully weigh the risks and potential benefits and make sure you are aware of all potential side effects and what to watch for. If even the smallest side effect is noted, discontinue the drug.

There are other motility agents available that you may wish to try first, which I will list below, leaving Reglan for a last resort.

· Motilium® - (Domperidone) - Currently not available in the U.S.
This is also a dopamine antagonist; however, domperidone does not cross the blood-brain barrier so it does not have the undesirable side effects that metoclopramide may. It works to increase esophageal peristalsis, LES pressure and gastric contractions.

· Erythromycin - An antibiotic with the side effect of increasing gastric motility. This is currently being widely used in low doses (not the higher antibiotic doses) for delayed gastric emptying as this does not have the unfortunate side effects that are possible with metoclopramide.

· Urecholine® (Bethanchol) - Urecholine is used to treat urinary and bladder problems. It helps to empty the bladder and often stimulates gastric motility, increases gastric tone, and restores rhythmic peristalsis improving gastric emptying time.

So as a final note, like all drugs, Reglan will help some, but not everyone, some will have side effects, some won’t. The only way to know for sure either way is to try it. Given that, just be sure that the child’s condition is severe enough that it warrants taking the chance and that you watch closely for reactions.

If you have tried Reglan and seen these side effects in your child, or haven’t tried it but heard scary stories from others, it is always a good idea to help other parents by sharing your experience. Please remember that ALL medications have potential side effects. If you have tried Reglan please do share your personal experience with other members but be conscious and respectful of the fact that everyone's experience will differ. Just like reflux, no two children react the same way and what works for one child may not work for another. This can be a frightening drug for parents to consider so please be ever mindful and try to scare people further. Remember, it has helped children too so there are two sides to Reglan as with any medication out there.

For More Information
http://www.rxlist.com/cgi/generic2/metoclo_wcp.htm
http://www.medicinenet.com/metoclopr...al/article.htm
http://www.nlm.nih.gov/medlineplus/d...r/a601158.html
http://www.webmd.com/drugs/drug-8679-Metoclopramide+Oral.aspx?drugid=867 9&drugname=Metoclopramide+Oral&pagenumber=6
http://www.oshmanlaw.com/pharmaceuti...on/reglan.html
http://www.reflux.org/reflux/webdoc01.nsf/(vwWebPage)/EPS-TD.htm?OpenDocument
http://www.namiscc.org/newsletters/July01/tardive.htm
http://www.ninds.nih.gov/disorders/tardive/tardive.htm