April 24, 2009

FDA, New Black Box For Reglan

Upset stomach, heartburn and stomach acid might be the least of you concerns.

The FDA announced this month that it is putting a black box warning on all drugs containing the pharmaceutical ingredient, metoclopramide (Reglan).

Now first you should know what and where the “Black Box” is.
Wikipedia states: In the United Staes, a black box warning (also sometimes called a black label warning or boxed warning) is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning.
A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects…

Reglan is a prescription medication that is used to treat common and everyday reflux. It does this by increasing the contractions in your upper digestive system which in turn speeds up how fast your stomach empties.

The FDA reports that approximately 2 million people take drugs containing metoclopramide and it may be causing more harm that good. What they consider long term (more than 3 months) makes your risks even higher.

But what was the big, bad side effect the pushed the FDA to post the newest Black Box?
Tardive Dyskinesia (TD) seems to be the monster and it is characterized by symptoms of involuntary or repetitive movements of the extremities. This would also include; lip smacking, grimacing, tongue protrusion, rapid eye movements, puckering of the lips and impaired movements of the fingers. But what’s even worse, these symptoms don’t seem to go away after the medication is stopped.

The FDA does report that these symptoms are directly related to the length of time a person takes the medication. But as I recall Acid reflux is normally a chronic problem and they report that any thing over 3 months is long term. So why would anyone subject themselves to TD for only 3 months of an acid free stomach. There has got to be a better way. Oh, and those at greatest risk are the elderly, especially elderly women.

Other side affects of Reglan include but may not be limited to: tremors or uncontrolled muscle movements, fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing, depressed mood, thoughts of suicide or hurting yourself, hallucinations, anxiety, agitation, seizure, or jaundice (yellowing of your skin or eyes).

OK, so lets look at some other things we can do to prevent or treat acid reflux.

1) Add acidophilus to your regular regimen. The acidophilus will help restore the natural balance of bacteria in your gut. This will aid in the overall digestion of your food. This is really good for everyone.

2) Add “full spectrum” digestive enzymes to your regimen. These help the body break down all food types (proteins, fats, and carbs). Again, these are good for anyone that eats.

3) DGL, a form of licorice root that has one component removed (DGL means De-Glycerrhizinated Licorice) may help in sever cases.

4) Aloe Vera Juice may help promote healing and calm the digestive tract.

5) Eat small frequent meals instead of three “all you can eat” meals

6) Avoid foods that increase the acid production in your stomach, like: tomatoes, chocolate, alcohol, refined sugar, greasy foods, processed foods, etc.

7) Drink plenty of pure, clean water

And once again, if you take any medication and begin to experience adverse affects contact your doctor immediately. PLEASE also report symptoms to the FDA’s MedWatch program at MedWatch


  1. Shari,

    Is this just the prescription drugs or over-the-counter as well? I take Prilosec to control my acid reflux. I have it mostly under control by regulating my diet, but sometimes I want pizza, spaghetti....

  2. It is the ingredient, metoclopramide (Reglan). No medication (prescription or OTC) should be taken for any extended period of time. I always encourage people to take digestive enzymes to help with things like acid reflux, hiatal hernias, and just general health. I am glad to hear that you are cautious about what and how often you take meds. though.