Shire Pharmaceuticals, Inc, a subsidiary of Ireland-based Shire plc, has received a warning letter from the U.S. Food and Drug Administration stating that the company’s promotional magnets advertising the attention deficit disorder drug Vyvanse are misleading.
Shire’s Human Genetic Therapies division in headquartered in Cambridge and Lexington, Mass.
The FDA says that the magnets violate marketing rules because they fail to disclose risks associated with the drug, therefore making it seem safer and more effective than the drug maker has demonstrated. The FDA said it became aware of the situation after photographs of the magnets were taken at a pediatric medical office in 2011 and submitted as part of a complaint to a “Bad Ad” program.
The letter, dated May 6, reads in part, “This omission of risk information is particularly concerning given that the PI for Vyvanse discusses numerous risks, including a boxed warning regarding the potential for abuse.” A boxed warning is the most serious type of warning assigned to an approved drug.
Vyvanse is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children, and it’s approved for ages six through 12. Vyvanse is not recommended for patients with a number of conditions, the FDA said, including advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncratic reaction to sympathomimetic amines, glaucoma, agitated states, history of drug abuse; and use during or within 14 days following the administration of monoamine oxidase inhibitors.
The FDA is requesting Shire stop disseminating the magnets and respond to the letter by May 20 describing its plan “to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.”
The FDA said failure to respond could result in FDA regulatory action, including seizure of materials.
