Last week, as reported by the Associated Press, the FDA forced Shire, PLC to retract certain promotional materials after it scrutinized the claims made by the company regarding the benefits and risks of its drug Intuniv.
According to the Intuniv label, the drug is approved for the treatment of symptoms related to attention deficit hyperactivity disorder in patients between the ages of 6 – 17. In a letter to Shire, dated June 22, 2010, the FDA stated that there were no clinical studies to support the company’s claims for improvement of “individual behavioral problems,” such as “bedtime blowups,” “homework hassles,” and “mall meltdowns” – issues that would obviously be appealing to frustrated and exhausted parents.
Further, the FDA cited serious health risks associated with certain inactive ingredients in Intuniv, such as hypotension, bradycardia, and syncope if given to patients with a history of hypersensitivity to these ingredients. It also emphasized that the way in which the drug was marketed was misleading and false, noting the clinical brochure’s pictures and phrases. For example, the “Parents’ Guide” presented the image of a child in a monster suit, representing a patient with ADHD, and depicted it next to statements such as “Reveal the kid within, A difference the whole family can see… (Brochure Holder, Waiting Room Brochure cover…that’s where INTUNIV comes in…”(Parents’ Guide). “Imagine the moments ahead,” was a recurring tagline in the promotional materials, as well.
The FDA cited numerous specific discrepancies between Shire’s claims and the medical community’s research, and ended with a request for Shire to immediately withdraw the promotional materials for Intuniv, as described in the letter.