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Botox, Myobloc Linked to Serious Side Effects, Deaths

In February 2008, the Food & Drug Administration (FDA) announced that Botox, Botox Cosmetic and Myobloc would undergo a safety review following reports of serious side effects, including the deaths of some children.  Botox, Botox Cosmetic and Myobloc are injectable drugs that contain botulinum toxin.  According to the FDA, most of the severe reactions occurred in children treated for limb spasticity associated with cerebral palsy, an off-label use of the drugs. 

Botox, which is made with botulinum toxin type A, is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating).  Botox Cosmetic, which also uses botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. Myobloc, which is made from botulinum toxin Type B, is approved for the treatment of adults with cervical dystonia.

Botox, Botox Cosmetic, and Myobloc Side Effect Reports

In January 2008, the consumer advocacy group Public Citizen petitioned the agency two weeks ago to strengthen warnings on the products' labels because of serious adverse reactions. An analysis conducted by Public Citizen of FDA data found that between Nov. 1, 1997, and Dec. 31, 2006, the makers Botox, Botox Cosmetic and Myobloc had reported 180 U.S. cases of people developing serious conditions after receiving injections. Those 180 cases included 16 deaths, four of which occurred in children.

According to the FDA the Botox, Botox Cosmetic and Myobloc reactions reported resemble botulism.   The reactions have occurred when botulinum toxin spreads beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. The FDA said that the adverse reactions may be due to overdosing

The reports of adult botulism cases described symptoms including patients experiencing difficulty holding up their heads, dysphagia and ptosis.  Some reports described systemic effects that occurred distant from the site of injection and included weakness and numbness of the lower extremities.  Among the adult cases that were serious, including hospitalization, none required intubation or ventilatory support. No deaths were reported. 

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