FDA Letter to Eli Lilly Regarding Cymbalta Marketing

September 21, 2007 The U.S. Food and Drug Administration (FDA) letter said that a mailer for Cymbalta Delayed Release Capsules overstates effectiveness and omits some of the most serious and important risk information associated with its use. Lilly was asked to stop using the material. The misleading claims were related to the degree of pain relief experienced by people with peripheral neuropathic pain related to diabetes. The FDA said that Lilly's patient survey of pain interference in daily living measures a general concept that cannot be captured with a single item question such as rating the level of . . .