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Allergan Subpoenaed Over Botox

Mar 4, 2008 | Parker Waichman Alonso LLP

The maker of Botox is facing heat over off-label use of the product.  Yesterday, Allergan Inc. said it received a subpoena from the US Department of Justice investigating the promotion of Botox.  The drugmaker said authorities were seeking documents regarding promotional, educational, and other activities relating to Botox and said it believes the subpoena is related to alleged off-label promotion of Botox to treat headaches.  Botox, best known for smoothing facial wrinkles, is not approved as a headache treatment.

Botox and similar drugs are already at the center of a Food & Drug Administration (FDA) safety review.  The review came after  the FDA received reports of systemic adverse reactions including respiratory compromise and death following use of botulinum toxins types A and B for both FDA-approved and -unapproved uses.  Botox and another drug,  Myobloc have been linked to 16 deaths and more hospitalizations; reactions reported are suggestive of botulism in which the toxin spreads in the body beyond the injection site.  The most serious cases involved hospitalization and death and occurred mostly in children treated for cerebral palsy-associated limb spasticity (severe arm and leg muscle spasms).  Use of botulinum toxins for this purpose is not approved in the US in children or adults.  The FDA is aware of the literature describing the use of botulinum toxins to treat limb spasticity; however, the safety, efficacy, and dosage of botulinum toxins have not been established for the treatment of limb spasticity of cerebral palsy or for use in any condition in children under 12.

Botox (botulinum toxin type A) is medically approved for treating cervical dystonia (rigid neck muscles), blepharospasm (eyelid spasm), and severe primary axillary hyperhydrosis (excess sweating).  Botox Cosmetic (botulinum toxin Type A) is approved for temporary improvement in the appearance of moderate to severe facial frown lines.  Myobloc (botulinum toxin Type B) is approved for the treatment of adults with cervical dystonia; the safety and effectiveness of Myobloc for cervical dystonia in children has not been established.  The botulinum toxin blocks nerve impulses to muscles, relaxing them.

The FDA is reviewing data from clinical studies submitted by the manufacturers of Botox, Botox Cosmetic, and Myobloc, as well as post-marketing adverse event reports, and medical literature.   Current labeling for Botox, Botox Cosmetic, and Myobloc describes adverse reactions occurring near the injection site for each product’s approved uses.  The Warnings sections for the products note that important systemic adverse effects, including severe difficulty swallowing and breathing occurred in patients with neuromuscular disorders after local injection of typical.  The FDA now has evidence that similar, potentially life-threatening events can occur following local injection in those with underlying conditions such cerebral palsy associated limb spasticity.

Until the FDA has completed its review, healthcare professionals who use medicinal botulinum toxins should understand that potency amounts indicated by “Units” or “U” differs among the products and are not comparable from one product to the next.  They should also be alert to the potential for adverse effects and know effects have been reported as early as one day and as late as several weeks following treatment, providing patients and caregivers with the information to identify the signs and symptoms of these effects, especially worsening or unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness.