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More Drug Warnings Sought for Labels

Regulation: Top transportation officials say many medicines cause side effects, such as drowsiness, that make drivers and pilots accident-prone.


WASHINGTON — A top official with the National Transportation Safety Board urged federal regulators Wednesday to place more warning labels on household drugs such as cold medicines that can trigger drowsiness and cause accidents on roads, railways and in the air.

"Over-the-counter medicines and prescription drugs contribute to transportation accidents," said Carol Carmody, vice chairwoman of the National Transportation Safety Board. "We have made recommendations to address some aspects of the issue. We have not solved it yet."

The safety board has investigated more than 150 accidents in the last 14 years involving drivers, pilots or other operators who may have been impaired by over-the-counter or prescription medications. Transportation officials say drug companies do not provide enough guidance on labels to help people determine the effects of common medicines.

"Several over-the-counter medicines and prescription drugs can adversely affect an individual's performance without him or her even knowing it," Carmody said during the opening of a two-day hearing on the issue.

Several drug companies have been reluctant to implement new warning labels. Two pharmaceutical officials told a joint meeting of the transportation board and the Food and Drug Administration that every drug is carefully tested and evaluated for adverse reactions.

"Drugs are allowed on the market if their benefits exceed their risks," said Dr. Bert Spilker, a senior vice president for the Pharmaceutical Research and Manufacturers of America, a trade group.

A national panel of experts testified on the issue at the safety board's headquarters. Researchers delivered mixed opinions to transportation and drug regulators on the possible dangers of driving while taking some medicines.

Dr. John Weiler of the University of Iowa, who studies the relationship between drugs and driving, said his research has indicated that several common respiratory drugs make driving difficult. At a driving simulator in Iowa City, tests have revealed some drivers have difficulty following cars, keeping consistent speeds and staying in one lane of traffic while taking over-the-counter drugs. He said the effects vary from person to person.

Two specific accidents raised the awareness of transportation officials to the potential dangers of legal medicines. In 1998, a crash of a Greyhound bus in Pennsylvania killed six people; tests revealed the driver had recently taken an over-the-counter medication. In 1999, three people were killed when a small plane crashed in New Jersey; tests showed the pilot had taken prescription medication used to treat migraine headaches.

Carmody, whose agency has been studying the issue for nearly two years, said new warning labels would give drivers, pilots and captains more information to make decisions about when it is safe to operate an automobile, plane or ship.

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