Driving Home the Point:

Medicines, Impaired Driving, and You

Ali Mohamadi, MDMedical OfficerProfessional Affairs and Stakeholder Engagement

RADD-ONDCP SummitJuly 11, 2014

Factors that Can Impair Your Driving

Emotions

Age

MedicalConditions

Fatigue

Alcohol

Medicines(OTC and Prescription)

Illicit or IllegalDrugs

Distractions

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Driving and Medicines: Proceed Cautiously

Some of the ways medicines can affect your driving:

• Decrease attentiveness

• Impair judgment of time and distance

• Slow motor skills (reflexes)

• Add to effects of fatigue or lack of sleep (“drowsy driving”) and other causes of drowsiness

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Prescription Medicines That May Affect Your Ability to

Drive• Sleeping pills• Anti-anxiety medications• Some antidepressants• Products containing codeine

(including pain relievers)• Some cold remedies and allergy

products• Tranquilizers

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When Does FDA Communicate Emerging

Drug Safety Info? • After an important drug safety issue

has emerged after approval– Serious adverse drug reactions– Medication errors

• After having completed an analysis of available data– Seriousness of event, magnitude of risk,

extent of patient exposure, potential for risk mitigation

• In some cases, before having reached a decision about whether regulatory action is warranted

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How Does FDA Communicate Its

Recommendations?

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Drug Labeling

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Medication Guide

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Bottle Stickers: Not Regulated by FDA

OTC Medicines: Some Common Misconceptions

• OTC medicines don’t have risks

• I can take OTC medicine any way and in any amount I want to without harm

• I don’t need to read the label – I know all I need to know about the medicine

• My family and I have used the medicine before and we have never been harmed

• If some medicine is good, more is better

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OTC Medicines That May Affect Your Ability to Drive

• Antihistamines• Cold and allergy products• Anti-diarrheals• Anti-emetics

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OTC Drug Facts Label

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Drug Facts Example: Antihistamines

• Providers and patients should partner to choose and use medicines safely by reviewing labels and medication guides

• Check all your medicine labels and medication guides before you hit the road

Do they say anything about drowsiness?

Do they say anything about driving or operating machinery?

• With your health care professional, consider if you can choose and use a different medicine or dose that is less likely to have those effects

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CDER Professional Affairs and Stakeholder Engagement

Email: ali.mohamadi@fda.hhs.gov

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