Over-the-counter (OTC) Medicament Safety

In 1972, the FDA began reviewing ingredients contained in an estimated 300,000 nonprescription medicament products sold in the U.S.

The FDA in August, 1992, proposed banning 415 ingredients from seven categories of prescription medicaments because they had not been shown safe and effective as claimed. In similar actions, the FDA banned 223 ineffective ingredients from 19 categories of products in November, 1990, and 111 ineffective weight control ingredients in August, 1991.

Most of the ingredients named had already been discontinued, but several products containing one or more of the ingredients remain on the market, and manufacturers are being required to reformulate or remove them from the market.

The ban on some ingredients is not total, however; an ingredient banned for one use may be allowed for another. For example, salicylic acid is banned as an external pain reliever in insect bite and sting treatment medicaments, but has been found effective for removal of warts, corns, and calluses. In some cases ingredients known to be safe, but which would not be allowed for certain claims, may be used as inactive ingredients. For example, peppermint, while not effective as a digestive aid, may be used as a flavoring agent.

There are OTC monographs-standards or recipes-that list the ingredients allowed, the claims permitted, and requirements for labeling. Most OTC products are produced in accordance with monographs and the manufacturers do not have to apply for premarket testing. If a firm applies for approval of an "innovator" OTC product--one for which there is no monograph-a New Medicament Application must be filed, just as with a prescription medicament, and it may take just as long to obtain marketing approval.

The FDA does sometimes require supplemental information for OTC products on the market. OTC labeling for aspirin was updated when it was discovered there was an association between the use of aspirin in children with viruses and Reye's syndrome, a potentially fatal brain disease.

New combinations are allowed. Adjustments are made. Monographs are revised. The FDA usually will not take enforcement action against marketed OTC medicaments provided the producer follows the guidelines and does not exaggerate the benefits of the remedy to the public.

This does not mean OTC medicaments have no potentially dangerous side effects.

OTC labels must carry warnings on certain products. For example, phenylpropanolamine (PPA) is a common ingredient in diet aids. It can induce rapid heartbeat and high blood pressure, a major concern for people already prone to high blood pressure. In extreme cases, the medicament's stimulants can induce dangerously rapid and erratic heartbeats.

Digestive aids such as antacids can interfere with the way the body absorbs other substances. Overuse of antacids can cause digestive problems, primarily diarrhea or constipation.

Sodium bicarbonate contains a lot of salt and shouldn't be used by people with high blood pressure or a history of heart failure.

Recent studies have shown that regular use of ibuprofen and the pain killer, acetaminophen, can cause further damage in people who already have mild kidney disease. l

Even vitamins, if used improperly, can be harmful.

The FDA is aiming to have manufacturers put the sodium content of medicaments on labels, and make certain the print used is optimum size and style so that it can be easily read by purchasers.

In the meantime, the safety question about how far we can go with the diagnosis and treatment of our own illnesses is still a matter of debate among professionals and consumer advocates. For example, when vaginal yeast infection remedies changed from Rx to OTC there was a question about the self-diagnosis. But the FDA advisory board ruled vaginal yeast symptoms are so specific that once a woman is diagnosed and treated by a physician, there is no need to return should those symptoms recur.