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FDA to address impairment from OTC, prescription drugs

Agency may change warning labels and increase patient education because of fatal vehicle crashes linked to legal medications.

By Victoria Stagg Elliott, amednews staff. Dec. 3, 2001.

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The Food and Drug Administration is considering new label requirements that would address possible sedation or impairment caused by over-the-counter and prescription drugs.

This step is the result of a request by the National Transportation Safety Board, which has recorded thousands of car, bus, boat and airplane accidents resulting in at least 100 deaths -- all linked to legal medications such as antihistamines, muscle relaxants, painkillers, anti-anxiety drugs and anti-depressants.

The statistics have been increasing in recent years. But this rise may result from improved tests to detect such substances in bodily fluids.

The FDA and NTSB held a joint meeting, the first of its kind, last month to consider the issue. The FDA is expected to announce decisions and possible policy actions within a year.

"Little guidance or medication labeling exists to help consumers determine which medicines could adversely affect their ability to operate a vehicle," according to an FDA statement.

Several European countries already mark packages with color-coded symbols that indicate the degree to which a drug may induce drowsiness or may otherwise impair a person's ability to operate heavy machinery such as a car.

Physicians, who will be expected to provide some of the consumer education about this issue when they write prescriptions, reacted positively.

"It's important not to trivialize this," said John Weiler, MD, professor of internal medicine with the University of Iowa, who testified at the meeting. He also has published research on the impact of several allergy medications on a person's ability to drive.

"There are drugs that are relatively safe in certain circumstances, and there are drugs that are relatively dangerous in those same circumstances. We have to have some way we can let people know which is which," Dr. Weiler said.

But many questions remain, and more research is needed to determine which drugs cause impairment and how much. Experts speculate that this could become a part of a drug's phase III clinical trials.

"We need more investigation to understand the degree of impairment we see with them and understand what's really happening when people take these medications," Dr. Weiler said.

There are also many questions as to what kind of warning labels will be effective. Some information about impairment is already included in the packaging of many over-the-counter drugs and the patient information insert for prescription drugs. Most believe much of it goes unread.

"We hope they read that label on the bottle, but do they? No," Dr. Weiler said. "We've trivialized these warnings so much because we put warnings on everything."

Effectiveness questioned

Critics of labeling practices also say the type size of the label is too small and the language too technical for many consumers. But even if the information is read and understood, it is still unclear whether it will deter some from driving while under the influence of a legal medication.

"It's like the warning labels on cigarettes," said James Hadley, MD, clinical associate professor and otylarnyngologist with the University of Rochester in New York. "People are still going to smoke, but it may make people a little more aware."

And some question how involved physicians can really be in this issue. Informing a patient about possible side effects from a drug, including drowsiness and impairment, is a part of the consent process, but many concede that it doesn't always happen as it should.

"Physicians are not involved enough in this issue, but they're liable for the things that can happen," Dr. Weiler said. "They ought to think about it."

The drug industry is also against any additional labeling requirements.

"There currently exist ample opportunities for physicians and patients to be informed about a product's safety profile," said Bert Spilker, MD, PhD, senior vice president of scientific and regulatory affairs with the Pharmaceutical Research and Manufacturers of America, during his meeting testimony. "We recommend that there not be any changes to FDA's current practice."

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 ADDITIONAL INFORMATION: 

Staying alert

The FDA/NTSB meeting exploring medications' effects on drivers called for:

• More prominently displayed information and/or color-coded symbols regarding a medication's impact on a person's ability to operate a vehicle.
• Additional research regarding a medication's impact on motor skills and alertness.
• Clearer definitions of impairment.
• Patient and physician education on the issue.

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Weblink

Agenda for FDA/National Transportation Safety Board joint public meeting, Transportation Safety and Potentially Sedating or Impairing Medications (http://www.ntsb.gov/Events/2001/FDANTSB/agenda.htm)

Article, "Effects of Fexofenadine, Diphenhydramine, and Alcohol on Driving Performance: A Randomized, Placebo-Controlled Trial in the Iowa Driving Simulator," Annals of Internal Medicine, March 7, 2000 (vol. 132, issue 5) (http://www.annals.org/issues/v132n5/full/200003070-00004.html)

Pharmaceutical Research and Manufacturers of America (http://www.phrma.org/)

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