Background on FDA Announcements
A special advisory panel convened by the FDA on Oct. 19, 2007, recommended that the agency not allow many common wintertime over-the-counter (OTC) medicines to be given to children younger than 6 years of age.
The hearing came in response to a petition that raised concerns about overdosing, citing confusion with directions or accidentally giving the same ingredient when administering multiple products. In rare cases, these actions may lead to a tragic overdose.
The panel of health experts specifically examined the risks and benefits associated with suppressant, decongestant and antihistamine agents in young children. The panel stated that it was “uncomfortable” that the benefits of these ingredients for children were estimated based on using a fraction of the dose shown in studies to benefit adults. This is because of variations in metabolism and weight in this age group.
Days prior to the Oct. 19, 2007, announcement, many manufacturers voluntarily removed medications with the ingredients in question specifically designed for children younger than 2 years of age from store shelves. Similar products intended for use in children older than 2 years of age stayed on store shelves as manufacturers waited for an official FDA ruling on how to apply the panel’s recommendations. Most anticipated the ruling to affect language on product labels.
Throughout the 2007-2008 winter season, the FDA cautioned parents to read label directions carefully and be aware of ingredients when giving multiple medications, and encouraged parents to consult a healthcare professional with questions.
The FDA reopened discussions on Oct. 2, 2008, after which they announced the need to gather more data on the safety and effectiveness of OTC medications containing suppressant, decongestant and antihistamine agents for children 2 to 6 years of age. They rejected the idea of an immediate ban on these medicines due to concern that it might drive parents to give adult medications to their youngsters. Officials are not giving a timetable for a decision.
On Oct. 8, 2008, the Consumer Healthcare Products Association (CHPA) announced that manufacturers of these products will voluntarily move toward re-labeling the medications instructing parents not to use them in children younger than 4 years of age. Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products. A transition period will occur instead of removing and replacing products currently on store shelves.