Over-the-Counter Drug Side Effects May Impair Driving, FDA Warns

Federal drug regulators are warning consumers about the potential impact that several over-the-counter medications may have on their ability to drive or operate heavy machinery, indicating that users need to be aware that the non-prescription drugs can cause significant drowsiness and impair cognitive functioning. 

The FDA issued a consumer update on Tuesday, warning consumers that over-the-counter (OTC) medications like antihistamines, diphenhydramine, and loperamide all contain common ingredients that may impact alertness and driving ability. The medications may also cause other side effects, such as unfocused thinking and slow reaction times.

Health officials warn that over-the-counter drug side effects can carry serious risks if consumers do not choose them carefully and use them exactly as directed.

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“You can feel the effects some OTC medicines can have on your driving for a short time after you take them, or their effects can last for several hours,” said Ali Mohamadi, M.D., medical officer at FDA. “In some cases, a medicine can cause significant ‘hangover-like’ effects and affect your driving even the next day.”

Antihistamines are used in many common cold and flu medications to treat a runny nose, sneezing, itchy throat and watery eyes. Antihistamines are often added to the active ingredients in combinations to reduce pain and fever, but usually cause drowsiness.

Diphenhydramine is the active ingredient in Benadryl. Along with drowsiness, it also can cause consumers to become unfocused and slow to react.

Loperamide is the active ingredient in Imodium, an antidiarrheal drug. It also can cause drowsiness and affect driving.

Anti-emetics, used to treat nausea, vomiting and dizziness, were also listed in the warning because of their tendency to cause sleepiness and fatigue and impair driving.

Read The Label

The update warns each drug has a “Drug Facts” label to guide consumers to make safe choices. The drugs also have a “When using this product” section, which will tell users how the medication may make them feel or warnings about drowsiness or driving while using the mediations.

FDA officials warn consumers to look for statements that say, “You may get drowsy,” “marked drowsiness will occur,” or “be careful when driving a motor vehicle or operating machinery” to indicate the OTC medications may be unsafe to take when driving.

Other important things to consider is how the medication may interact with outside substances, such as alcohol, sedatives and tranquilizers.

The warning also reminded consumers not to take more than one medication with the same active ingredient, which can cause additional side effects, and to check if the OTC medication should not be used for a specific condition with which you may have already been diagnosed.

The warning also advised consumers to find a different medication if they plan to drive.

“If you don’t read all your medicine labels and choose and use them carefully you can risk your safety,” Mohamadi said.

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