When Do You Need an Antacid? : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 3)

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.

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.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.