ROANOKE TIMES
Copyright (c) 1997, Roanoke Times
DATE: Thursday, February 27, 1997 TAG: 9702270035
SECTION: NATL/INTL PAGE: A-1 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: Associated Press
THE REGULATORY AGENCY has ordered over-the-counter medicine makers to use laymen's terms, simply saying ``lung,'' for example, instead of ``pulmonary.''
Americans will no longer have to pull out a magnifying glass and a dictionary to pick the best drugstore remedy, the government said Wednesday as it unveiled simpler labels for over-the-counter medicines.
The Food and Drug Administration proposal aims to help consumers tell at a glance how to properly use a nonprescription drug, its side effects and when to see a doctor - information now often buried in fine print and baffling medical jargon.
The news was welcome to 86-year-old Vera Santos of Washington, whose glaucoma makes it difficult to read today's drug labels.
``I'd read along and then everything would blur,'' she said while shopping in a drugstore.
``Oh, that's good,'' she exclaimed, pointing to a sample of the FDA's new labels. ``Yes, that's real good! I can read that with just one eye.''
It's the same sort of simplified label the FDA put on foods in 1994 to help consumers figure out nutrition, and it comes as Americans are turning to over-the-counter remedies four times as often as they consult a doctor.
Yet until now only a few members of the $18 billion nonprescription drug industry voluntarily produced easy-to-read instructions
``We definitely think the more user-friendly a label is, the better it is for consumers,'' said Meg Grattan of the Nonprescription Drug Manufacturers Association, which supports the FDA proposal. ``Nobody wants to read something that looks confusing.''
And if Americans don't read the label, the FDA says, they not only could pick the wrong cold medicine to treat their sniffles, they could be missing vital health warnings.
How many patients who take antidepressants called MAO inhibitors know never to take Robitussin or Dristan nasal decongestants or cough syrups - because the mix can kill? Or that mixing the heartburn medicine Tagamet with the prescription epilepsy drug Dilantin is dangerous? Or that aspirin and ibuprofen can cause stomach bleeding, so see a doctor if you have symptoms?
``Nonprescription medicines can be potent and can have real side effects,'' said FDA Commissioner David Kessler. ``The new [over-the-counter] drug labels will be clear and concise. Consumers will not have to hunt around for information on the label.''
The FDA also ordered companies to use laymen's terms, simply saying ``lung,'' for example, instead of ``pulmonary.''
To illustrate the change, the FDA bought Rite-Aid brand Tri-A-Phen, a drugstore brand antihistamine and nasal decongestant. Tiny print lists the dose, side effects and health warnings. In fact, consumers must read 16 lines crammed on the bottle's side before learning that people on certain antidepressants should not use Tri-A-Phen.
The FDA put a sample label on the bottle that says up front and in larger print, color-coded to catch consumers' attention: ``Do Not Use'' if you take those antidepressants and ``Ask a Doctor Before Use'' if you have heart disease, high blood pressure or other diseases the drug could affect.
Smaller sections list the active ingredients and the symptoms they relieve, so people with a runny nose and cough will know the remedy is appropriate. ``Stop using this product,'' the label warns, if side effects such as dizziness, fever or a persistent headache occur.
A few companies beat the FDA to the simpler labels, saying it makes good marketing sense.
Thompson Medical Co. was first, relabeling a hemorrhoid medication in 1995 to highlight a health warning - don't use Hemorid if you also take blood pressure medicine - that had been buried in fine print. The heartburn medicine Pepcid AC went an extra step, offering an illustrated insert explaining just what heartburn is and five ways to avoid it without drugs - information patients would get if they went to a doctor instead of opting for over-the-counter relief.
The public has four months to comment on the proposal. If the rule then becomes final, over-the-counter drug manufacturers would be allowed two years to put the new labels on their products, an industry expense estimated at about $14 million.
LENGTH: Medium: 84 lines ILLUSTRATION: PHOTO: AP. The Food and Drug Administration says new labels,by CNBlike the one on the left, will make it easier for people to know
what they're taking. color.