Yesterday, the FDA published information on a new Limitation of Use statement required for extended-release ADHD drugs (here). Specifically, this class of drug has been shown to be associated with greater risk of significant weight loss and other side effects in children 6 years of age or younger “than older children taking the same medication at the same dosage.”
The Agency states that the analysis it performed “found that patients younger than 6 years have higher plasma exposures (i.e., higher levels of the drug in their bodies) and higher rates of side effects than older children. In particular, clinically significant weight loss (at least 10% decrease in the Centers for Disease Control and Prevention (CDC) weight percentile) was observed in both short- and long-term studies with extended-release stimulants. For these reasons, the benefits of extended-release stimulants may not outweigh the risks of these products in patients younger than 6 years with ADHD.” The Agency is, therefore, requiring that a Limitation of Use statement be added to these products, or, for those firms that already have a Limitation of Use section in their labeling, that the statement be revised to include this finding “to ensure consistent messaging across the drug class.”
The FDA is making this announcement in advance of label revisions “to bring public attention to this risk.” The Agency’s announcement contains information for parents, guardians, and healthcare providers as well as a number of other sections that provide data and information regarding the risks associated with use of extended-release ADHD products in this age group. For those of you who are application holders, check with the FDA regarding the new information that must be included in revised labeling, watch for the FDA’s postings of drug safety information, and be prepared to make the necessary label changes.
