• Government
• Profession
• Business
• Opinion
• Health

• Health reform
• H1N1
• P4P
• EMRs
• Medicare
• Liability
• AMA House
• » More

• Book Excerpt
• Business Pitch
• Meetings
• » More

• Contract Language
• Ethics Forum
• In the Courts
• Practice Management
• Technically Speaking
• » More

• Issue dates
• Regions
• Health plans
• Sections
• News briefs
• Columns
• Editorials
• Letters
• Writers
• Other years

• Search tips
• E-mail alert
• Radio
• RSS
• Mobile
• Subscribe
• Institutions
• Staff directory
• Advertising
• Permissions
• Reprints
• News media
• Site guide
• Useful links
• About
• Premium
• Contact

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.

• PRINT|
• E-MAIL|
• RESPOND|
• REPRINTS|
• SHARE

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. [...]