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October 2007

News & Media

Drug Companies Pull Children’s Cold, Cough Medicines 
October 15, 2007 

WASHINGTON – Last Thursday, drug manufacturers voluntarily pulled over-the-counter cold and cough medications for children under 2 after federal regulators and private doctors shared concerns about the potential health risks to infants and toddlers, USA Today reports. However, medicines for children older than 2 were not part of the recall, despite the fact that doctors have warned that those products also could be harmful to children between the ages of 2 and 6.

Linda Suydam, president of the Consumer Healthcare Products Association (CHPA), which represents the drug companies, told the newspaper that the medicines are safe and effective when used as directed, and that “the vast majority of parents and caregivers” use them properly. Recently, researchers found “rare patterns of misuse leading to overdose,” particularly in infants, she said.

Products being pulled include over-the-counter infant cold medications, such as Tylenol, Dimetapp, Robitussin, Triaminic and Little Colds. Currently, product labels carrying a recommendation that parents consult a doctor before administering the drug to young children. Now to better inform parents about the drug’s potential harmful effect, the Food and Drug Administration and the CHPA want the labels to say “do not use” for children under 2. Officially, the FDA will talk about the changes during public meetings held later this week.

Last month, FDA researchers advocated that the agency prohibit over-the-counter cold and cough medicines for children. In addition, the American Academy of Pediatrics also has advises that children’s cold and cough medicines are not safe or effective for kids younger than 6.