FDA warns on Endo direct mail pieces
The FDA fired off a warning letter to Endo Pharmaceuticals asking the company to halt distribution of two direct mail pieces for its Lidoderm pain patch because they contained unsupported claims and omitted certain risks associated with the patch.
The materials "are false or misleading because they make unsubstantiated effectiveness claims for Lidoderm, they omit and minimize serious risk information associated with the use of the drug and they inadequately communicate an important limitation in Lidoderm's approved indication," the FDA letter said.
The sales materials were sent to doctors in late 2004 and early 2005. An Endo spokesman said in a published report that the company was working with the FDA to take corrective action.