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Taming Tummy Turmoil

by Dixie Farley

A vague queasiness stirs in your stomach. Queasy quickly turns to severely nauseated. A sour bubble rises in your throat, and you dash for the bathroom in a cold sweat.

Whatever the cause, the nausea and vomiting of an upset stomach are nasty. Upset stomachs caused by motion or too much food or drink may respond to over-the-counter (OTC) medicines. For other upset stomachs, professional care and no medication often are best.

Motion Sickness

Paleness, yawning and restlessness often precede the nausea, vomiting and dizziness that occur in motion sickness, which most frequently strikes youngsters ages 2 to 12, but may occur at any age.

The primary culprit in this condition is excess stimulation to the inner ear's maze of fluid-filled canals, responsible for maintaining the body's balance. Poor ventilation, anxiety or other emotional upset, and visual stimuli may contribute to motion sickness.

Because motion sickness is easier to prevent than to treat once it has begun, it may help to take an OTC drug to prevent symptoms 30 to 60 minutes before traveling and then continue doses during travel.

The Food and Drug Administration considers four active ingredients to be safe and effective for use in OTC drugs for motion sickness, says Gerald Rachanow, deputy director of the monograph review staff in FDA's Office of OTC Drug Evaluation. The ingredients are cyclizine (Marezine and others), dimenhydrinate (Dramamine and others), diphenhydramine?(Benadryl and others), and meclizine (Bonine and others).

The active ingredients in these drugs are antihistamines. Their main side effect is drowsiness. Alcohol, tranquilizers and sedatives may increase this effect. Rachanow says anyone taking a drug for motion sickness should use caution when driving a vehicle or operating machinery and should avoid alcoholic beverages.

In large doses, OTC drugs for motion sickness may cause dry mouth and, rarely, blurred vision. "People with breathing problems such as emphysema or chronic bronchitis, glaucoma, or urinating difficulty due to an enlarged prostate should not take these drugs unless directed to do so by a doctor," Rachanow says.

OTC drugs for motion sickness have the following age restrictions:

• cyclizine-not for use under age 6
• dimenhydrinate-not for use under age 2
• diphenhydramine-not for use under age 6
• meclizine-not for use under age 12.

Before trying these drugs, or along with them, the following measures may also help stave off motion sickness:

• Don't read during travel.
• Keep your line of vision fairly straight ahead.
• Avoid excess food or alcohol before and during extended travel. Avoid all food and drinks on short trips.
• Stay where motion is felt the least the front seat of a car, near the wings of an airplane, or amidship (preferably on deck).
• Avoid tobacco smoke and other odors, particularly from food.

Heartburn

In the spring of 1995, FDA approved famotidine and cimetidine as the first drugs for OTC use that work systemically to reduce the amount of stomach acid produced. They are also sold by prescription at higher dosage levels to treat gastrointestinal illnesses such as ulcers.

The drugs are marketed OTC as Pepcid AC Acid Controller (famotidine) and Tagamet HB (cimetidine) to treat occasional heartburn, acid indigestion, and sour stomach in people age 12 and older. Pepcid AC may also be taken as a preventative before consuming food and beverages expected to cause these symptoms.

People should take no more than two Pepcid AC tablets or four Tagamet HB tablets in 24 hours, and should limit use at the maximum dose without consulting a doctor to two weeks. They should consult a doctor if they have swallowing difficulty or persistent abdominal pain, as these symptoms may indicate a more serious condition.

In addition, with Tagamet HB, people should consult their doctor before use if they also take any of these prescription drugs: theophylline (oral asthma medicine), warfarin (blood-thinning medicine), or phenytoin (seizure medicine). If people have questions about whether their medicines contain these drugs or about other drug interactions, they should call the manufacturer, SmithKline Beecham Consumer Affairs, at (1-800) 482-4394.

Most products approved to relieve heartburn, indigestion, or upset stomach from too much food or drink are antacids, which neutralize gastric acidity. Antacids may contain various active ingredients. The four general categories, with common brands and potential side effects, are:

• Sodium salts (Alka-Seltzer, Bromo Seltzer, and others)-People on a salt-restricted diet, especially if being treated for high blood pressure, should only take sodium antacids under a doctor's orders. FDA requires labels of all OTC antacids to give the sodium content. Because a risk of stomach rupture has been associated with sodium bicarbonate intended to be dissolved in water, FDA has proposed a "Stomach Warning" in product labeling: "To avoid serious in- jury, do not take until [insert product dosage form, e.g., "tablet," "powder"] is completely dissolved. It is very important not to take this product when overly full from food or drink. Consult a doctor if severe stomach pain occurs after taking this product."
• Calcium salts (Alka-2, Rolaids [Calcium Rich], Titralac, Turns, and others)- Extended heavy use of calcium antacids (20 grams or more daily for a prolonged period) may cause excess calcium in the blood, which can lead to kidney stones and reduced kidney function. People who already have impaired kidneys may develop milk-alkali syndrome (causing symptoms such as nausea, vomiting, mental confusion, and loss of appetite) with as little as 4 grams a day.
• Aluminum salts (ALternaGEL, Amphogel, Rolaids, and others)-Aluminum salts can constipate, so they're usually combined with magnesium salts to counter this effect. Overuse can weaken bones, especially in people with impaired kidney function, leading to conditions such as osteomalacia (softening of the bones, which causes symptoms such as tenderness, muscular weakness, and weight loss).
• Magnesium salts (Camalox, Gelusil, Maalox, Mylanta, and others)-These salts have a laxative effect, so they're usually combined with aluminum salts; Camalox also has calcium salts. Very prolonged use may cause kidney stones. Too much magnesium in the blood can cause heart, central nervous system, and kidney problems.

As this list shows, some antacid products contain a combination of antacid ingredients. Some also contain simethicone, which breaks up gas bubbles, making them easier to eliminate from the body.

"Antacids are fast-acting drugs," says Hugo Gallo-Torres, M.D., a medical officer in FDA's division of gastrointestinal and coagulation drug products. "They should bring relief within 15 to 20 minutes of each episode. If, after several episodes, there is no relief, then something else may be going on, something that requires a physician's evaluation."

Antacids may interact with many drugs. Gallo-Torres advises consulting a doctor before using antacids if you have a condition that requires adjusting sodium in your diet, or if you are taking a prescription medicine.

Overindulgence

Bismuth subsalicylate is recommended for overeating and drinking excessively. Bismuth also has some anti bacterial effect. The product, sold as Pepto-Bismol and generic brands, may cause a temporary, harmless darkening of the tongue or stool.

FDA has proposed that products containing bismuth subsalicylate have labeling warning not to give the drug to children and teenagers who have or are recovering from chickenpox, flu symptoms (nausea, vomiting or fever), or flu. The warning is needed because, like aspirin, bismuth subsalicylate is a salicylate and may be associated with an increased risk of Reye syndrome, a rare but serious illness that can occur in children and teenagers with those illnesses.

Other proposed warnings advise users not to take the drug if they're allergic to any salicylate, and to consult a doctor first if they have diabetes, gout or arthritis or if they take blood-thinning medicine.

Users are also advised to stop taking the drug if they have ringing in the ears. Rachanow explains: "This may happen when too much drug is taken or when another salicylate, such as aspirin, is taken at the same time."

Viral Infection

Nausea, vomiting and diarrhea may also be due to mild viral gastrointestinal infection. Children are especially susceptible. A doctor should be consulted if vomiting or diarrhea recur or persist, because dehydration or a chemical imbalance may result and require treatment. I is very important that patients recovering from viral gastrointestinal infection drink plenty of fluids.

General Advice

With stomach upsets in general, it's a good idea to call the doctor if symptoms last more than a few days. A doctor should be called if symptoms become severe-for instance:

• continuous vomiting or diarrhea
• extreme discomfort or pain in the gastrointestinal tract
• black stool (unless the drug you took, such as Pepto Bismol, contains bismuth subsalicylate)
• visible blood in the stool
• vomiting of blood or material that looks like coffee grounds, but which is actually digested blood.

Prolonged self-treatment may mask a more serious condition, such as an ulcer or cancer.

Women who are pregnant or breast feeding should consult their doctors before taking any drugs.

Fortunately, most upset stomachs get better by themselves or require minimal treatment. As with any medicine, it's important to read an OTC drug's entire label and follow directions carefully. And, as with any illness, it's important to know when to call the doctor.

The best way to deal with heartburn or indigestion is to avoid them in the first place. Simple preventive steps are:

• Avoid big meals. Your stomach must work long and hard to process them, which means it must produce a lot of acid. It helps to eat more frequent, smaller meals.
• 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.
• Eat your last full 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.
• Sleep with your head and shoulders propped up 6 to 8 inches, so that your body is at a slight angle. This gets gravity working for you and not against you. Digestive juices in your stomach are then more likely to head south, for your intestines, instead of back up into your esophagus to cause a burning sensation.
• Avoid tight-fitting garments. They can literally compress your stomach, making it more likely that the stomach's acid contents will back up into your esophagus.
• Avoid foods that contain a lot of acid, such as citrus fruits and tomatoes, and any other food that gives you problems.
• Cut down on caffeine. It makes your stomach produce more acid. Caffeine-heavy items include coffee, tea, chocolate, and some sodas.
• Cut down on alcohol and smoking. Both irritate the lining of your stomach and tend to lower esophageal sphincter pressure. When this happens, it's easier for the stomach's acid contents to shoot back up your esophagus.

Dixie Farley is a staff writer for FDA Consumer.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service Food and Drug Administration

We hope you found this reprint from FDA Consumer magazine useful and informative, FDA Consumer, the magazine of the U.S. Food and Drug Administration, provides a wealth of information on FDA-related health issues: food safety, nutrition, drugs, medical devices, cosmetics, radiation protection, vaccines, blood products, and veterinary medicine, For a sample copy of FDA Consumer and a subscription order form, write to: Food and Drug Administration, HFI-40, Rockville, MD 20857. *U.S. GOVERNMENT PRINTING OFFICE 1996-404-905/20050

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