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Botox Complications Require Caution

Jul 2, 2008 | Parker Waichman Alonso LLP

This year, Botox was linked to a number of hospitalizations and 16 deaths.  Of the deaths, four victims of the poisonous Botox injections were children.  An additional 87 people were hospitalized.  Botox and Myobloc have been linked to the injuries and fatalities because the botulinum toxin spread inside the bodies of the patients, killing some and injuring others.  The toxin spreading in the bodies of the children proved most serious, killing four children under the age of 16.  In addition to the deaths, there have been reported problems of muscle weakness and difficulty swallowing.  American consumer group Public Citizen says it has seen 180 reports sent to the US Food and Drug Administration (FDA) about Botox and Myobloc.  

Botulinum toxin, which is produced by the bacterium Clostridium botulinum and is known commercially as Botox and Myobloc, is one of the most powerful nerve poisons known.  Although best known for smoothing facial wrinkles, Botox is medically approved for treating cervical dystonia, or rigid neck muscles and is also used to treat stroke victims and medical conditions including excessive sweating.  Myobloc is only approved for the neck condition.  Both injections are made with forms of the botulinum toxin, which blocks nerve impulses to muscles, relaxing them.  In children, Botox is used when neurological disorders are present, such as Cerebral Palsy.  Injections are meant to allow the child to gain normal movement by weakening stronger muscles and strengthening weaker ones by forcing the stronger contracting muscles to relax.  While experiencing the drug’s effects, physical therapists work with the child to develop the weaker muscles.  Although not appropriate for all children with CP, the treatment may help some move normally.  Recently, the toxin is being used off-label to treat unremitting overactive bladder problems that do not respond to other therapies.

Of the seven types of botulism, only two—A and B—are currently used medically.  Of the products available in the United States, Botox and Botox Cosmetic are derived from botulinum toxin A and Myobloc from B.  This February, the FDA—which continues its safety review of these products—notified the public about reports of ill effects associated with the drugs.

It has long been known that injecting botulinum can cause unwanted effects in nearby muscles; injections to smooth eye creases may cause temporary eyelid drooping; however, there are more serious concerns over systemic reactions, or effects on distant muscles.  And, the FDA says that adverse effects do not always occur right away and may emerge weeks after treatment.

In addition to the 16 deaths, Public Citizen reviewed the FDA’s adverse-event reports and found 180 cases of serious effects like pneumonia and difficulty swallowing and breathing. In September 2005, the Centers for Disease Control and Prevention (CDC) reviewed 1,437 adverse reports:  406 after medical use of Botox—217 of them serious effects—and 1,031 after cosmetic use—36 serious.  Reports detailed cases of muscle weakness, difficulty swallowing, or aspiration pneumonia, a serious condition caused by breathing a foreign material into the lungs.  Wolfe said such problems could occur if botulinum toxin spreads from the injection site to places such as the esophagus, causing partial paralysis.