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Botox Maker Subpoenaed By Justice Department

FDA launched safety review last month after reports of deaths, complications

March 4, 2008

• Botox Maker Subpoenaed By Justice Department • FDA Issues Botox Warning • Public Citizen Wants Stricter Botox Warnings • A New Wrinkle: Botox Users May Become "Addicted" --- • Consumer Complaints

Allergan, Inc., the pharmaceutical giant that makes the anti-wrinkle substance Botox, says it has received a subpoena from the U.S. Justice Department and the U.S. Attorney's Office for the Northern District of Georgia. The agencies have requested documents regarding Botox promotional practices.

The company said its current understanding is that the inquiry involves questions regarding alleged off-label promotion relating to the use of Botox for the treatment of headache. While Allergan is currently in phase III clinical studies investigating the use of Botox for the treatment of headache, it is not an FDA-approved use.

The U.S. Food and Drug Administration (FDA) announced last month that it was conducting a safety review of Allergan Inc.'s Botox and a similar product, Myobloc, after receiving reports of deaths and breathing problems in some patients who were injected with Botox syringes.

According to the FDA, Botox is being injected at an alarming rate among children, especially those who are being treated for cerebral palsy-associated limb spasticity. Neither product is approved for such use in the U.S. and there have been deaths associated with the usage of the two treatments among children.

However, as bizarre it may sound, the FDA says there were no reports of deaths in adults, and some of the adverse reactions may have been related to an overdose of the products.

The company denied that it had been promoting unapproved uses of the drug.

"Although healthcare professionals, exercising their medical judgment, may generally prescribe or dispense a drug for indications not approved by the FDA (i.e., off label), it is Allergan's policy to promote its products only in a manner consistent with the FDA-approved product labeling," the company said in a statement, announcing the subpoena.

"In all circumstances, it is Allergan's policy to fully comply with all applicable laws, rules and regulations. Allergan's Healthcare Law Compliance Program is intended to ensure continued compliance with all applicable laws, regulations and industry guidance governing the sale and marketing of pharmaceutical and medical device products, as well as laws and regulations governing the reporting of prices for Government-reimbursed products."

Botox received its first FDA approval in 1989, and since then the company says it has been used to a variety of often serious medical conditions. However, it is perhaps best known among aging Hollywood stars and politicians as a wrinkle remover. The toxins, injected into the facial region, are known to smooth skin and provide a more youthful appearance.

Allergan said it will provide updates as it responds to the subpoena, and will fully cooperate with the U.S. Department of Justice to "satisfactorily address any and all of their questions regarding this matter."

An FDA spokesman said the agency didn't yet have a firm count on the number of deaths or serious side effects but said they were a "relative handful." He explained that the FDA is still reviewing its adverse-event reporting system and data submitted by Allergan and Solstice Neurosciences Inc., a private firm in Malvern, Pa., that makes Myobloc.

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