Child deaths linked to Botox11th February 2008
Health regulators in the United States are probing a number of children's deaths for a possible link to Botox, with which they had been treated to curb the symptoms of cerebral palsy.
The Food and Drug Administration said the children had received products containing botulinum toxin for their cerebral palsy, although the regulator has not approved it for that purpose.
The regulator said it was now reviewing the safety of Botox and Botox Cosmetic, made by Allergan Inc, and Myobloc, made by Solstice Neurosciences Inc.
Adverse reactions to the botox treatments including respiratory failure. It was unclear whether overdosing was involved, and the FDA said the probe did not necessarily indicate a problem with the products.
The reactions seemed to occur when the botulinim toxin, which causes botulism, spread away from the injection site.
They appeared to be similar to botulism symptoms, which include difficulty swallowing, weakness and breathing problems.
Russell Katz, director of the FDA's Division of Neurology Products at the Center for Drug Evaluation and Research, said the agency had received 'a number' of reports of serious adverse reactions to the products.
Currently, the drugs carry a warning that they should not be used in people with neuromuscular disorders.
However, some reports of hospitalisation and even death had been received of people without such disorders, Katz said.
Most of the serious cases were among children who had been treated for spasms, mostly in their lower limbs, he said, but declined to reveal the number of deaths or patients affected by adverse reactions.
The FDA's Adverse Event database for Botox and Myobloc found 180 adverse events in the United States, including 16 deaths, and four of these deaths occurred in children under 18, according to a petition filed last month by Public Citizen's Health Research Group.
The petition also called on the FDA to place a strong warning on such products.
Botox was first approved by the FDA in 2002 to improve the appearance of wrinkles, and, two years later, in the treatment of severe underarm sweating.
The botulinum toxin blocks nerve impulses to muscles, causing them to relax.
The FDA urged doctors and their patients to watch for signs of botulism poisoning, although it stopped short of recommending that the use of botulism-related products be stopped.
It said it would also review safety data from clinical trials already carried out by manufacturers.
Solstice Neurosciences said safety was always of primary importance, and that it supported further training of healthcare professionals in correct use of its products.
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Title: Child deaths linked to Botox
Author: Luisetta Mudie
Article Id: 5591
Date Added: 11th Feb 2008