The FDA Division of Drug Marketing, Advertising, and Communications (DDMAC) issued a warning letter to Shire Development Inc., after a review of a webpage and a video testimonial for Shire's drug Adderall XR Capsules (Adderall XR). featuring the celebrity Ty Pennington, that was posted on youtube.com by Shire.
According to the FDA, both the webpage and video overstate the efficacy of Adderall XR and the video omits important information regarding the risks associated with Adderall XR use.
The FDA states in its letter to Shire that the webpage broadens the indication for Adderall XR by suggesting uses that have not been approved by FDA and therefore they misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act.
The agency also noted that the video posted on youtube.com was not submitted to FDA for review in violation of agency protocol. The webpage and video raise significant public health and safety concerns through it's overstatement of efficacy and omission of important safety information, the FDA concludes.
According to FDA-approved product labeling (PI), Adderall XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The Indications and Usage section of the PI also includes information regarding special diagnostic considerations, the need for comprehensive treatment, and information about long-term use.
The FDA letter to Shire states that the webpage entitled "Difficulties caused by ADHD in adolescence" presents numerous claims about the consequences of untreated ADHD as well as claims about the impact of treatment with Adderall XR that are not accurate.
The video, according to the FDA, presents numerous efficacy claims for Adderall XR (see above), but entirely omits risk information for Adderall XR, including the contraindications, warnings, precautions, and common adverse events associated with the drug.
DDMAC has requested that Shire immediately cease the dissemination of violative promotional materials for Adderall XR and asked the company to submit a written response to their letter on or before October 7, 2008, stating whether they intend to comply with the agency's request by listing all promotional materials for Adderall XR that violated FDA regulations.