No More Fine Print Drug Labels

(As reported 3/11/99)
New Food and Drug Administration regulations taking effect Thursday require all nonprescription medicines to carry more consumer-friendly labels so patients can tell at a glance which drug will relieve their symptoms and how to use it safely.

Vice President Al Gore put on his glasses to emphasize his point that the new rules are necessary for making over-the-counter drug labels clearer, reports CBS News Correspondent Elizabeth Kaledin.

"Over 170,000 Americans wind up in the hospital every year because of misuse of over the counter drugs," he said Thursday. "That is unacceptable."

All of the common medicines that Americans rely on every day to relieve colds, allergies, and headaches will bear the same label.

"When a sick child needs an over-the-counter medicine in the middle of the night, parents shouldn't have to struggle to decipher the label," said Health and Human Services Secretary Donna Shalala.

Instead of having microscopic information in varying formats, the new labels will have a standardized chart listing active ingredients, uses, warnings, and directions in big print. "When that's done in a uniform way, it becomes easier for a consumer to go in time after time, look for the information that they need, and also make some comparisons from product to product," FDA Commissioner Dr. Jane Henney says.

The change will greatly benefit older people who tend to take more prescription drugs, people such as sixty-year-old Doris Cook, whose high blood pressure medicine could be dangerous when taken with antihistamines and decongestants. "If I don't know what the medication in the bottle is, how do I known they won't affect my medication that I'm already on, without giving me a stroke or a heart attack?"

The new labels will begin appearing within the next year -- just in time, doctors say -- as a growing number of medicines once available only with prescriptions, start showing up on drug store shelves. Clinton administration officials expect most drugs to carry the new label within another two years; a few manufacturers have until 2004 to phase in the changes.

The agency proposed the new labels in 1997, but the regulation did not become final until Thursday. About 100,000 drugs, from cough medicines and anti-itch creams to highly potent pain relievers and heartburn medicines, are sold without a prescription.

Although over-the-counter drugs largely are safe, studies suggest their misuse cause over 170,000 hospitalizations a year, half of which could be prevented by better consumer education.

To combat this problem, the new labels appear in larger print, with sections marked "Warnings" and "Directions," so consumers can quickly find the precise information they need. A "Do Not Use" section will highlight other medicines that interact dangerously with the over-the-counter remedy.

Both the $29 billion nonprescription drug industry, which helped FDA develop the new label, and the National Association of Chain Drugstores -- whose pharmacists now help bewildered consumers choose over-the-counter remedies -- praise the change.