Contact:
Leslee Williams, 847/981-7131
Lori OKeefe, 847/981-7084
Carolyn Kolbaba, 847/981-7945
Below is a highlight of a policy published in the February issue of Pediatrics, the peer-reviewed, scientific journal of the American Academy of Pediatrics (AAP). To receive full text or interview contact information for this policy, please contact the AAP Division of Public Relations at [email protected] and ask for C272.
AAP RECOMMENDS MANDATORY PHARMACEUTICAL LABELING
CHICAGO--The American Academy of Pediatrics has issued a revised policy recommending mandatory labeling of inactive ingredients on prescription and over-the-counter pharmaceutical products. The statement, which appears in Pediatrics, the journal of the American Academy of Pediatrics, has been issued to inform pediatricians and the public about incomplete voluntary labeling of inactive ingredients by the pharmaceutical industry. More than 773 chemical agents have been approved by the Food and Drug Administration as inactive ingredients, including sweeteners, dyes and coloring agents and preservatives, some of which may cause negative reactions. Drugs taken orally are not required to have inactive ingredients disclosed on the label. The most common pediatric reactions to inactive ingredients may include seizures, headaches, bronchospasm and diarrhea. According to a recent survey of labeling on 102 chewable and liquid pediatric pharmaceuticals, 90 percent labeled sweeteners, 80 percent labeled dyes and coloring agents and 65 percent labeled preservatives. Although 90 percent labeled sweeteners, few provided the specific ingredient. In addition, voluntary disclosure is exempt from revealing "trade secret" ingredients, including fragrance and flavoring ingredients. "The voluntary system is clearly inadequate," concludes the American Academy of Pediatrics.
-30-
The American Academy of Pediatrics is an organization of 51,000 pediatricians dedicated to the health, safety and well-being of infants, children, adolescents and young adults.
RSS