Botox has been implicated in the deaths of four children, prompting calls for more warnings on the drug’s label. Taken together, side effects from both Botox and Mylobloc, another drug made with botulinum toxin, have been linked to 16 fatalities and 87 additional adverse events that required hospitalizations. In all of the cases, the botulinum toxin spread inside the bodies of the patients, killing some and injuring others.
Botox is best known for smoothing facial wrinkles, but the drug is also medically approved by the Food & Drug Administration (FDA) for treating cervical dystonia, or rigid neck muscles. In some cases, Botox is also used to treat stroke victims and other medical conditions including excessive sweating. Myobloc is only approved for the neck condition.
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.
Consumer groups are demanding new black box warnings be included to Allergan Inc.’s Botox and Solstice Neurosciences Inc.’s Myobloc packaging to indicate the medications can cause death in some cases.
As well as deaths, there have been reported problems of muscle weakness and difficulty swallowing. And American group Public Citizen says it has seen 180 reports sent to the FDA about Botox and Myobloc. Spokesman Dr. Sidney Wolfe—director of Public Citizen’s Health Research Group—said users should be told of early symptoms such as dry mouth, trouble breathing, slurred speech, or droopy eyelids, adding “Significantly improved warnings would increase likelihood of earlier medical intervention and could prevent complications, including death.”
Reports detailed cases of muscle weakness, difficulty swallowing, or aspiration pneumonia, a serious condition caused by breathing a foreign material into the lungs. Reports to the FDA do not prove a product caused a particular problem, but the agency uses the reports to find patterns of potential complications. “There are no safety issues raised in the petition that are not already addressed in the labeling for Botox,” Allergan said, adding that it is in frequent dialogue with the FDA to ensure proper labeling and submits all information it receives on adverse events regardless of whether or not they are related to Botox. Solstice Neurosciences reported it recently provided safety data to the FDA and stood behind the drug’s current prescribing information. Wolfe said such problems could occur if botulinum toxin spreads from the injection site to places such as the esophagus, causing partial paralysis. Instructions for Botox and Myobloc mention the issue but it is easy to miss, he said.
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