[U.S. Food and Drug
Administration]

This article was published in FDA Consumer magazine several years ago. It is no longer being maintained and may contain information that is out of date. You may find more current information on this topic in more recent issues of FDA Consumer or elsewhere on the FDA Website, by checking the site index or home page, or by searching the site.
 
A Burning Question: When Do You Need an Antacid? 
by Tom Cramer

You can't believe you ate the whole thing. But you did. All seven courses.     
Then you had two helpings of dessert. Then, to be social, you had a couple of  
drinks. Or maybe three or four.

And now you're paying for it. You've got a "burning sensation" in your         
stomach or your chest, or maybe you feel all knotted up inside.

Your first reaction may be to reach for your favorite antacid to make the      
hurting go away. And if you do, you won't be alone.

Americans are currently spending close to $1 billion per year on these         
popular, over-the-counter drugs. Used according to directions and in           
moderation, they can quickly relieve the symptoms associated with occasional   
heartburn and indigestion. But these useful products may not always be         
necessary, and they have their dark side if used improperly.

"Improperly" means taking too much of an antacid over a short period, or       
using antacids frequently over a long period (weeks, months or years).         
Frequent and prolonged use of these products can cause irreparable harm to     
your heart, kidneys or bones.

Even if used occasionally and in moderation, antacids can mean bad news for    
people with special medical conditions.

Hugo Gallo-Torres, M.D., a medical officer with FDA's Center for Drug          
Evaluation and Research, said it's a good idea to consult your doctor before   
using antacids if you:
- are on any kind of medication
- are pregnant or breast-feeding
- have kidney problems
- have chronic constipation, diarrhea or colitis
- have stomach or intestinal bleeding
- have an irregular heartbeat
- have any kind of chronic illness
- have symptoms that may indicate appendicitis. 

Though they cause problems for some, most people can take antacids without     
worrying. Consumers who use them only once in a while, and as directed, are    
unlikely to experience significant side effects.

But, like most everything else in life, moderation is the key.

"Antacids are useful drugs--they serve a purpose," said Gallo-Torres.          
"Ideally, though, it's always better to try dealing with heartburn and         
indigestion--at least initially--without taking any medications at all, or by  
avoiding trouble in the first place."

Gallo-Torres said there are some simple steps you can take that may help       
prevent heartburn or indigestion.
- Don't eat big meals. Your stomach has to work long and hard to process       
them, which means it has to produce a lot of acid. It helps to eat more        
frequent--but smaller--meals.
- Eat more slowly. Downing a lot of food in a hurry can overwhelm your         
stomach, which responds by producing extra digestive acids.
- After you eat, don't lie down right away. If you do, you're more likely to   
have heartburn, because gravity is now preventing food from going speedily to  
the intestines. It's also a good idea to eat your last big meal at least       
three hours before bedtime. When you go to sleep, everything slows down,       
including your digestive system, so food you've eaten right before bedtime     
will stay in your stomach longer. It won't feel good.
- Don't wear tight-fitting garments. They can literally compress your          
stomach, making it more likely that the stomach's acid contents will enter     
your esophagus and cause a burning sensation.
- Cut down on caffeine; it makes your stomach produce more acid.               
Caffeine-heavy items include coffee, tea, chocolate, and some sodas.
- Avoid foods that contain a lot of acid, such as citrus fruits and tomatoes,  
and any other food that gives you problems.
- Cut back on alcohol and smoking. Both irritate the lining of your stomach    
and both tend to lower esophageal sphincter pressure. When this happens, it's  
easier for the contents of your stomach to shoot back up into your esophagus.
- Sleep with your head and shoulders propped up six to eight inches, so that   
your body is at a slight angle. This gets gravity working for you and not      
against you, and the digestive juices in your stomach are more likely to head  
south, for your intestine, instead of back up into your esophagus.

"If you do take an antacid, remember that what you're taking is a drug,"       
Gallo-Torres said. "It is a drug that, in the vast majority of cases, should   
be used only for occasional relief of mild heartburn or indigestion. Antacids  
are fast-acting. They should bring relief within minutes. If you're taking     
antacids and there's no relief, then something else may be going on,           
something that requires a physician's evaluation."

Igor Cerny, a pharmacist with FDA's Center for Drug Evaluation and Research,   
agreed. "If you find yourself taking antacids frequently," he said, "you need  
to say to yourself: 'Wait a minute.... I wasn't doing this before, so why am   
I doing it now? Something might be wrong with me.'

"If your symptoms last more than two weeks, go see your doctor," he            
recommended. "Two weeks is the general rule of thumb. Beyond that, taking      
antacids can actually mask a more serious medical problem."

Cerny said it's a good idea to see your doctor even sooner--preferably right   
away--if you're experiencing any symptoms severe enough to interfere with      
your lifestyle, symptoms such as continuous vomiting or diarrhea, extreme      
discomfort or pain in your gastrointestinal (GI) tract, vomiting of blood or   
material that looks like coffee grounds (but which is actually digested        
blood), or any of these accompanied by fever.

"Using antacids to alleviate serious symptoms like these is like trying to     
put out a building fire with a hand-held extinguisher," Cerny said. "Serious   
symptoms require professional evaluation and treatment."

A Quick Look Inside

Your entire digestive system is called the alimentary canal, or GI tract.      
About 30 feet from beginning to end, it includes your mouth (where digestion   
actually begins), esophagus, stomach, small intestine, and colon (also called  
the large intestine). Antacids do most of their work in the stomach.

The stomach serves as a kind of "holding tank" for food before it moves on to  
the intestines, where the major part of digestion takes place. But the         
stomach does more than just hold food. It helps with digestion, too. It        
secretes pepsin and hydrochloric acid, which work together to break down       
proteins into simpler compounds.

Under normal conditions, the digestive process rolls along quietly and         
efficiently, unnoticed. But every once in a while something happens down       
there that catches your attention: a burning sensation, a cramped or bloated   
feeling, or other unpleasant phenomena that tell you something is not quite    
right.

The pH Factor

Antacids make you feel better by increasing the pH balance in your stomach.    
The pH system is a scale for measuring the acidity or alkalinity of a given    
environment (in this case, your stomach). The scale goes from zero to 14.

Seven is neutral. Below seven is acid. Above seven is alkaline.

Normally, the acid level in your stomach is about 2 or 3. Trouble may start    
when your pH drops below those numbers.

To make you feel better, an antacid need not bring the pH level all the way    
up to 7 (neutral), which would be a highly unnatural state for your stomach    
anyway. In order to work, all the antacid has to do is get you to 3 or 4. It   
does this by neutralizing some of the excess acid. (See accompanying story,    
"What's in an Antacid?")

So What's Wrong with Me Anyway?

The world of gastrointestinal disorders is a complex and sometimes baffling    
one. If you're feeling pain or discomfort in your GI tract, it could be        
something as unworrisome as simple indigestion, or maybe a stress ulcer.

Or it could be cancer.

In between these extremes are a billion other possibilities (a slight          
exaggeration, but you get the idea).

For example, your doctor may say you're suffering from non-ulcer dyspepsia.    
According to the Handbook of Nonprescription Drugs (ninth edition), non-ulcer  
dyspepsia "refers to intermittent [on and off] upper abdominal discomfort,     
the cause of which is not clearly defined."

In other words, when you get right down to it, non-ulcer dyspepsia is a        
catch-all term used for all sorts of stomach upset problems. Some symptoms     
include upper abdominal pain, nausea, vomiting, bloating, and indigestion.

Indigestion is another fuzzy word. Some people like to call it sour stomach,   
or acid indigestion, or upset stomach, or acid stomach.

It could mean that you have a touch of gastritis (when your stomach lining     
becomes inflamed by too much acid secretion). Or it could mean you've simply   
eaten too much at once, and all that food is sitting heavy in your stomach,    
like a bowling ball, trying to get digested (as in the case of the massive     
overindulgence described at the beginning of this article).

Then there's heartburn, which is another matter.

Heartburn happens when the stomach's contents, along with all its corrosive    
digestive juices, goes into reverse and shoots back up into the esophagus      
(the tube that extends from the pharynx, or throat, into the stomach).         
Normally, the pressure in your stomach is lower than the pressure in your      
esophagus, which helps prevent food from reentering the esophagus. But once    
in a while the delicate pressure system can break down.

This unsettling event, called gastroesophageal reflux (heartburn), may         
sometimes announce itself with an embarrassing belch.

But whether you make a noise or not, you feel the burning. The lining of your  
stomach is fairly accustomed to an acid environment, but your esophagus        
definitely isn't, so even a little acid in there will sometimes be enough to   
get your attention.

If gastroesophageal reflux is happening to you all the time, then you may      
have something called gastroesophageal reflux disease. It could be that your   
esophageal sphincter (the "door" between your esophagus and your stomach) is   
weak, chronically allowing the stomach's contents to push back out into the    
esophagus, burning it.

If the burning sensation is a little lower, and stays around for more than a   
few days, you could have another problem altogether: a peptic ulcer. An ulcer  
is simply a sore in your stomach that keeps getting irritated by all the acid  
swirling around down there.

Antacids can be used to treat all these GI problems. But most people who       
experience occasional discomfort somewhere along the GI tract, are likely not  
dealing with an ulcer, or stomach cancer, or anything else major.

Chances are it's run-of-the-mill heartburn or indigestion.

You don't need to see a doctor for occasional heartburn or indigestion. The    
hurting will disappear on its own. If you want some relief in the meantime,    
antacids will fit the bill nicely.

Again, it should be emphasized that if you experience unpleasant GI symptoms   
for more than two weeks, or if your symptoms are severe, it may be more than   
something run-of-the-mill.

Get it checked out.

Tom Cramer is a staff writer for FDA Consumer.
Recipe for Relief

FDA requires that every antacid on the market be safe (which means the         
antacid won't cause serious side effects, provided you take it in the proper   
dosage over the recommended period of time) and effective (which means the     
antacid will do what it's supposed to do).

Drug manufacturers must make and label their antacids according to specific    
guidelines in FDA's monograph on antacids. If manufacturers don't follow this  
federal antacids "recipe," they are not allowed to market their products.

According to FDA's monograph, an antacid is safe and effective if it meets     
the following conditions:
- It must contain at least one of the antacid active ingredients (acid         
neutralizers ) approved by the agency. (All the approved ingredients are       
listed in the antacid monograph.) 
- It must contain a sufficient amount of the active ingredients.               
Specifically, each active ingredient included in the antacid product must      
contribute at least 25 percent to the product's total neutralizing capacity. 
- In a laboratory test, the antacid must neutralize a specific amount of acid  
and keep it neutralized for at least 10 minutes.
- The label on the antacid must state that the product is good only for        
relieving the symptoms of "heartburn," "sour stomach," "acid indigestion,"     
and "upset stomach associated with these symptoms." The label can't make any   
other medical claims.
- The label must contain certain warnings concerning proper dosage, side       
effects (such as constipation or diarrhea), and how much sodium the product    
contains.
- The label must warn about the product's possible interactions with other     
drugs. Antacids can increase or decrease the speed at which some medications   
are eliminated from the body. For example, antacids can block the body's       
absorption of tetracycline, an antibiotic.
- The label must give directions for using the product, and it must carry a    
warning not to use the product for more than two weeks except under the        
advice and supervision of a physician. 

--T.C.
What's in an Antacid?

The opposite of an acid is a base, and that's exactly what antacids are.

But a base all by itself can't neutralize the acid inside you. For reasons     
that are best explained on a blackboard in chemistry class, a base needs some  
chemical "helpers," or ingredients, to accompany it on its neutralizing        
mission into your stomach.

All antacids contain at least one of the four primary "helpers" or             
ingredients: sodium, calcium, magnesium, and aluminum.

Here's a brief rundown of the composition and some potential side effects of   
various antacids:

Sodium (Alka-Seltzer, Bromo Seltzer, and others) 

Sodium bicarbonate or baking soda, perhaps the best known of the               
sodium-containing antacids, is potent and fast-acting. As its name suggests,   
it's heavy in sodium. If you're on a salt-restricted diet, and especially if   
the diet is intended to treat high blood pressure, take a sodium-containing    
antacid only under a doctor's orders.

Calcium (Tums, Alka-2, Titralac, and others) 

Antacids in the form of calcium carbonate or calcium phosphate are potent and  
fast-acting. 

Regular or heavy doses of calcium (more than five or six times per week) can   
cause constipation. Heavy and extended use of this product may clog your       
kidneys and cut down the amount of blood they can process, and can also cause  
kidney stones.

Magnesium (Maalox, Mylanta, Camalox, Riopan, Gelusil, and others)

Magnesium salts come in many forms--carbonate, glycinate, hydroxide, oxide,    
trisilicate, and aluminosilicates. Magnesium has a mild laxative effect; it    
can cause diarrhea. For this reason, magnesium salts are rarely used as the    
only active ingredients in an antacid, but are combined with aluminum, which   
counteracts the laxative effect. (The brand names listed above all contain     
magnesium-aluminum combinations.)

Like calcium, magnesium may cause kidney stones if taken for a very prolonged  
period, especially if the kidneys are functioning improperly to begin with. A  
serious magnesium overload in the bloodstream (hypermagnesemia) can also       
cause blood pressure to drop, leading to respiratory or cardiac depression--a  
potentially dangerous decrease in lung or heart function.

Aluminum (Rolaids, AlternaGEL, Amphogel, and others)

Salts of aluminum (hydroxide, carbonate gel, or phosphate gel) can also cause  
constipation. For these reasons, aluminum is usually used in combination with  
the other three primary ingredients.

Used heavily over an extended period, antacids containing aluminum can weaken  
bones--especially in people who have kidney problems. Aluminum can cause       
dietary phosphates, calcium and fluoride to leave the body, eventually         
causing bone problems such as osteomalacia or osteoporosis.

It should be emphasized that aluminum-containing antacids present virtually    
no danger to people with normal kidney function who use these products only    
occasionally and as directed.

Simethicone

Some antacids contain an ingredient called simethicone, a gastric defoaming    
agent that breaks up gas bubbles, making them easier to eliminate from your    
body.

FDA says simethicone is safe and effective in combination with antacids for    
relief of gas associated with heartburn. But not all antacids contain this     
ingredient.

If you're looking for relief of symptoms associated with gas, read the         
antacid's label carefully to make sure it contains simethicone.

--T.C.


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