FDA to Study How Teens View Drugs

Washington, DCThe FDA has announced it is undertaking a study to better understand how teens view prescription medications. This information is important because some drugs, such as Adderall, may be frequently prescribed to teens, who may not fully understand or appreciate the risks of Adderall side effects or adverse reactions. This information may also be vital because some drugmakers, including the maker of Adderall, have been warned by the FDA about marketing their drug to teens and adolescents.

The FDA has announced it will undertake a 5,000-person study to provide insight into how teens react to prescription drug advertisements. The agency is concerned that because teenagers have different cognitive abilities from adults, they may not give proper attention to warnings about side effects associated with medications. The study will reportedly focus on drugs to treat acne and drugs to treat ADHD - such as Adderall - because those are the conditions that have risen in public awareness recently.

“The need for understanding how adolescents weigh risks and benefits is particularly critical given the potential adverse events associated with use of the drug classes that are marketed directly to adolescents,” wrote the FDA in a document posted by the Government Printing Office (gpo.gov; 7/21/14).

The agency noted that a variety of factors influence how teenagers process information, including the cognitive, social, emotional and developmental process. Those factors not only influence how information is processed but also how risks and benefits are weighed.

“Consumers must consider tradeoffs with regard to the product’s risks and benefits in deciding whether to ask their health care professionals about the product,” the FDA wrote. “Presenting technically factual information is important, but other factors can also affect potential consumers.”

Shire, distributor of Adderall, has been warned about how it markets its drug to teens. In 2008, the pharmaceutical company received a warning letter from the FDA concerning its activities. The letter concerned a marketing video featuring Ty Pennington and a web page for the drug and warned that both the web page and video overstate the efficacy of Adderall XR while omitting important information concerning the drug’s risks.

Specifically, the FDA noted that the video entirely omitted risk information, including “contraindications, warnings, precautions, and common adverse events.” Furthermore, the FDA warned that marketing for the drug implied that Adderall XR could treat certain difficulties linked to ADHD when those claims were not backed up by scientific studies.