US warns Endo on sales material for pain patch

WASHINGTON (Reuters) – Some Endo Pharmaceuticals sales
material for the Lidoderm pain patch was misleading because it
contained unsupported effectiveness claims and omitted
important information about risks, U.S. regulators said in a
letter released on Wednesday.

The U.S. Food and Drug Administration told the company to
immediately stop distributing two direct mail pieces.

The materials “are false or misleading because they make
unsubstantiated effectiveness claims for Lidoderm, they omit
and minimize serious risk information associated with use of
the drug and they inadequately communicate an important
limitation in Lidoderm’s approved indication,” the FDA letter
said.

Regulators said the materials left out warnings about
wearing the patch for too long and omitted advice on how to
store and dispose of the product so that it is out of reach of
children and pets, which can be harmed by ingesting a new or
used patch.

The company also failed to note that Lidoderm should be
applied only to intact skin, not broken or inflamed skin,
according to the FDA’s letter.

The sales materials were sent to doctors earlier in 2005
and in 2004, Endo spokesman Bill Newbould said.

“We’re working with the FDA to take corrective action,” he
said.

Shares of the Chadds Ford, Pennsylvania-based company fell
3 cents to $25.96 in afternoon trading on Nasdaq.