In February, the US Food and Drug Administration, which has a continuing safety review of these products, notified the public about reports of ill effects associated with the drugs. Most of the serious cases resulted from medical, not cosmetic, uses of the toxin. Medical treatments typically require much larger doses, and many of the patients have other health problems that increase their risk.
The reactions, which included serious and sometimes deadly effects like respiratory failure, involved a range of doses and uses, many of them off label. The most severe reactions occurred in children treated for limb spasticity associated with cerebral palsy, an off-label use in children and adults.
Because this safety review depends on voluntary reports from medical and patient sources, it is often not possible to tell exactly what is to blame for the unwanted effects — poor technique, wrong dosage, an underlying medical problem or a hazard of the drug itself.
Public Citizen, a consumer advocacy organization in Washington, has petitioned the drug agency to force manufacturers to warn doctors about the reported complications. The group reviewed the agency’s adverse-event reports and found 180 cases of serious effects like pneumonia and difficulty swallowing and breathing, as well as 16 deaths. In September 2005, the US Centers for Disease Control and Prevention reviewed 1,437 adverse reports: 406 after medical use of Botox (217 of them serious effects) and 1,031 after cosmetic use (36 of them serious).
The proportion of serious reports was 33-fold higher for patients treated for medical problems than for those receiving cosmetic treatments.
Although it has long been known that injecting the toxin can cause unwanted effects in adjacent muscles — for example, injections to smooth creases around the eyes may cause temporary drooping of the eyelids — recent concerns involve what are called systemic reactions, or effects on distant muscles.
Dermatologists who use the drug for wrinkle reduction say that in experienced hands and properly diluted and administered, Botox is extremely safe. The worst disasters have occurred when unqualified practitioners administered the drug.
The drug agency has told doctors who use the toxin to give patients and their caregivers information about the signs and symptoms of adverse effects and the need to seek “immediate medical attention if they have worsening or unexpected difficulty swallowing or talking, trouble breathing or muscle weakness.” Doctors and patients should also know that adverse effects do not always occur right away, the agency said, but may show up even weeks after treatment.
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