WASHINGTON -- Inadequate or hard-to-read warning labels on common non-prescription drugs mask potential adverse effects and can endanger consumers, particularly the elderly, members of Congress charge.
At a joint hearing yesterday of two congressional subcommittees concerned with health matters, lawmakers said the Food and Drug Administration relied too much on industry to monitor the safety of over-the-counter drugs and charged that the agency had been slow in completing safety and effectiveness studies of many common drugs.
Rep. Ron Wyden, chairman of the Small Business Committee's Subcommittee on Regulation, Business Opportunities and Energy, said Americans had a false sense of security about non-prescription drugs, from aspirin to antihistamines to skin creams.
"Most Americans don't think twice about taking medications they can buy at the neighborhood store," the Oregon Democrat said at the hearing. Labels mislead consumers "by omitting serious side-effect warnings from container labels altogether, or by listing the warnings in fine print," he said.
Rep. Marilyn Lloyd, chairman of the Select Committee on Aging's Housing and Consumer Interests Subcommittee, said that although the elderly are major consumers of prescription and non-prescription drugs, researchers often do not test drugs on older adults and fail to study the results of taking different drug products at the same time.
Older drug consumers "are particularly susceptible to mismedication and the inappropriate combination of drugs," said the Tennessee Democrat. "They are also more likely to have impaired vision, which effects their ability to read medicine labels."
Mary Ponder, vice president of the National Consumers League, a non-profit advocacy group in Washington, testified that the Food and Drug Administration should standardize the labeling of non-prescription drugs, conduct testing to assure that labels are easy to read and promote more consumer education on properly using these drugs. "We believe consumers of all ages are having problems with OTC labels as they are," she said.
Ms. Ponder said the non-prescription drug industry had developed voluntary labeling guidelines. But when the consumer group tested the print, they found it was so small that only 48 percent of people over age 18 could read the labels, and that the number dropped to 32 percent for people over 51, she said.
James D. Cope, president of the Non-prescription Drug Manufacturers Association, said Americans had used non-prescription drugs for decades with relatively few adverse effects, and that surveys indicate the vast majority of consumers read labels on their medicines. The industry is supporting a "Read the Label" campaign.