NEWS & EVENTS: Antihistamine Labels Promote Safety


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A Healthy Dose for Inhalers

Labeling has prompted safer use of over-the-counter (OTC) antihistamines, an industry association told a government panel.

Speaking before a joint FDA/ National Transportation Safety Board meeting in November on transportation safety issues such as accidents caused by drivers who misused medications or experienced side effects was R. William Soller, PhD, senior vice president and director of science and technology for the Consumer Healthcare Products Association. He explained that "OTC antihistamines have clearly demonstrated a history of safe and effective use when used according to label directions. Labels play a crucial role in responsible self-medication by including vital information such as directions for use and warnings, and research shows consumers are reading them."

Soller cited a recent study by Roper-ASW (New York City), which found that 95% of consumers say they read directions before they take an OTC medication for the first time, and 91% say they look for information about side effects and interactions.

In addition, he noted, "the safety of OTC antihistamines currently on the market has been thoroughly studied. FDA's expert advisory panels evaluated their side effects and, where appropriate, OTC antihistamines are required to bear specific warnings related to important side effects, like drowsiness. With more than 850 million packages of OTC antihistamines sold in the last ten years for adult use, the safety profile of OTC antihistamines is excellent. Studies show a low correlation, if any, between OTC antihistamine use and serious accidents."

The new Drug Facts label being introduced for all OTC drugs, he noted, will help consumers even more because of its more-readable and easier-to-understand format.

Erik Swain

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