Over the Counter Drugs: Tummy Turmoil

by Food and Drug Administration (FDA)

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

FDA recently approved four 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.

Pepcid AC Acid Controller (famotidine), Tagamet HB (cimetidine), and Axid AR (nizatidine) are marketed OTC as a preventative before consuming food and beverages expected to cause heartburn, acid indigestion, or sour stomach. Pepcid AC and Tagamet HB also are labeled for relief of the symptoms. A fourth acid reducer, Zantac 75 (ranitidine hydrochloride), is labeled only for relief. The drugs are for people age 12 or older.

Users should take no more than four tablets of Tagamet HB or two tablets of the other acid reducers 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 injury, 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, Tums, 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.

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.