A panel of FDA advisers voted to ban over-the-counter cough and cold medicine for children under the age of six because they aren’t working and are causing injuries.
The vote comes after major manufacturers withdrew more than a dozen cough and cold products labeled for infant and baby use. However, the FDA only has the power to recall products that are an immediate hazard to the public; so total removal of the products may not happen.
In the early 1970s children’s cough and cold medicines were approved and assumed helpful in treating children, but since then have been found to be ineffective and potentially dangerous. Manufacturers disagree stating their medicines are safe and effective when used as directed. However, standards for clinical trials have changed over the last thirty years and thousands of drugs currently sold were approved under older, less strict standards.
Linda Suydam, president of the Consumer Healthcare Products Association, the trade group that represents over-the-counter medicines pledged the industry would study the medicines as recommended and try harder to educate parents to avoid overdoses that in rare cases have been fatal.
Information for this article was contributed by Gardiner Harris of The New York Times and Andrew Bridges of The Associated Press.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.