FDA WARNING_LETTER - Mallinckrodt Inc. - September 25, 2008

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) issued a Warning Letter to Mallinckrodt Inc. regarding a patient brochure (MET 221) for Methylin (methylphenidate HCI) Chewable Tablets and Oral Solution. The brochure was found to be false or misleading, misbranding the drug in violation of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(a) & 321(n); cf. 21 CFR 202.1(e)(6)(i), (ii), &(e)(7)(viii)).

The violations include: 1. **Overstatement of Efficacy:** The brochure implies Methylin can reduce the likelihood or severity of consequences of untreated ADHD (e.g., poor academic performance, violent behavior, substance abuse) without substantial evidence or clinical experience. 2. **Omission/Minimization of Risk:** The brochure fails to disclose important contraindications (e.g., use with MAO-Is) and warnings (e.g., sudden death in patients with pre-existing cardiac abnormalities, long-term growth suppression). It also misleadingly suggests Methylin helps avoid appetite decline, despite the PI stating anorexia and weight loss are common side effects. Risk information is presented with less prominence and readability than efficacy claims. 3. **Unsubstantiated Comparative Claims:** The brochure suggests