Drug Label Dangers
Dr. Janet P. Engle was working as a pharmacist in a large chain store when an elderly man asked her what he should take for his insomnia. Dr. Engle, now a member of the Board of Trustees of the American Pharmaceutical Association, said she'd be happy to help, but first needed to know what other medications he was taking.He told her that he was taking Excedrin every night before going to bed so that pain from his arthritis would not disturb his sleep. And therein lay his problem. "He didn't know that Excedrin has as much caffeine as a cup of coffee," recalled Dr. Engle. Instead of recommending a sleep aid, she advised him to stop taking Excedrin and to use a different pain reliever that was free of caffeine.Spurred by stories such as this of consumer confusion and misunderstanding of over-the-counter (OTC) drugs, and one estimate that such confusion leads to $10 billion worth of hospitalizations a year, the U.S. Food and Drug Administration is in the final stages of preparing new rules on the labeling of OTC medicines. The proposal, called "the most far-reaching" in 20 years by James D. Cope, President of the Nonprescription Drug Manufacturers Association, would standardize the format of the labels and require larger type sizes so they are easier to see. Experts agree that improvements in OTC drug labeling, and other educational efforts, are needed because many consumers underestimate the potential dangers of store-bought medicines. OTC drugs can sicken or even kill a user if the drug intensifies or aggravates an underlying medical condition -- high blood pressure, for example -- or interacts with another medication. Users seeking fast, fast relief can also harm themselves by taking more than the recommended dosage. The proposed new labels are similar in concept to the nutrition labels now required on food products. The proposal would require that:*Information be presented in graphical boxes for easier reading, and always in the same sequence so that consumers would know where to look to find out, for example, what active ingredients the products contain.*The label clearly show the amount of active ingredient in each dose to aid comparison shopping, among other things.*The type used in the labels be no smaller than 6 point to aid people with less-than-perfect vision *Warnings be highlighted better, via the use of headings such as "Allergy Warning" or "Alcohol Warning" or through the use of pictograms. Proposal "On the Fast Track"Changes in OTC drug labeling have actually been under consideration by the FDA since 1991, but the current proposal is now "on the fast track," according to Cazemiro Martin, the FDA chemist in charge of writing the final rules. Nevertheless, the FDA extended the public comment period on the proposal until October 6 from its original deadline this month at the request of two industry trade groups who wanted more time to study its impact.