A Medical Device Daily

Allergan (Irvine, California), the manufacturer of Botox and various breast implant products, said it has received a subpoena for Botox-related documents.

The company said that the request from the Department of Justice, U.S. Attorney’s Office for the Northern District of Georgia includes materials related to promotional, educational and other activities for the anti-wrinkle injection.

The company believes the subpoena relates to the alleged promotion of Botox as a headache treatment. Allergan is currently in late-stage studies on using Botox as a headache treatment, but said the injection is not approved by the FDA for such use.

The company said it plans to fully cooperate with the DoJ and that its policy is to promote its products consistent with FDA-approved labeling.

Botox has garnered increased scrutiny in the past few months.

In apparent response to reports of deaths associated with injections of dermal fillers, the FDA in February said it is reviewing Botox, and Myobloc made by Solstice Neurosciences (Malvern, Pennsylvania) (Medical Device Daily, Feb. 11, 2008).

Disclosure of that investigation concerning the products came just days after the consumer advocacy group Public Citizen (Washington) filed a petition with regulators calling for stricter warnings on Botox and Myobloc (Medical Device Daily, Jan 28, 2008).

The group said it knew of 180 reports of harmful side effects, including 16 deaths, and that these had been reported to the FDA from November 1997 to December 2006. Four of the deaths occurred in people under age 18, Public Citizen said.