New Botox Warnings
U.S. Food and Drug Administration (FDA) place a black box warning on Allergan Inc.’s Botox (botulinum toxin type A) and Solstice Neuroscience Inc.’s Myobloc (botulinum toxin type B). Adverse reactions, some serious and even fatal, were related to botulinum toxins spreading beyond the injection site to other parts of the body. This can cause muscle weakness, swallowing problems and aspiration pneumonia. Four of the 16 fatalities involved children under 18 years of age.
The FDA has received at least one report of a patient hospitalized after getting injections for cosmetic purposes, but it was “unlikely” that the drug was to blame, Russell Katz, director of the neurology products division at the FDA’s Center for Drug Evaluation and Research, told reporters.
Most of the severe reactions occurred in children treated for limb spasticity associated with cerebral palsy, an off-label use, Katz said. Such off-label uses are appropriate if the physician believes they are, Katz said.
The reactions announced by the FDA Friday resembled botulism, a rare but potentially deadly paralyzing illness caused by botulinum toxin in tainted food, the agency said in what it called “an early communication about an ongoing safety review” of Botox, Botox Cosmetic and Myobloc, the three brands sold in the USA.
The products’ labeling already warns of the “rare potential” for serious problems — such as difficulty swallowing and breathing — far from the site of the injection in patients with neuromuscular disorders. The label also describes the possibility of adverse side effects near the injection site, such as drooping eyelids after injections for frown lines.
But, Katz said, “we believe we now have reports for distant side effects … in patients without underlying neuromuscular disorders,” including the children with spasticity, which generally is not considered a neuromuscular disorder. The FDA has received reports of fewer than 100 cases of adverse reactions linked to the injections, Katz said, adding that “different people have different numbers.”
Public Citizen, a consumer advocacy group, petitioned the agency two weeks ago to strengthen warnings on the products’ labels because of serious adverse reactions. Katz said the FDA already had been looking into the problem when it received the petition.
“Our analysis of FDA data found that between Nov. 1, 1997, and Dec. 31, 2006, the makers of the drugs had reported 180 U.S. cases of people developing serious conditions after receiving injections,” Sidney Wolfe, director of the Public Citizen Health Research, said in a statement Friday. Those 180 cases included 16 deaths, four of which occurred in children, Wolfe said.
In a statement responding to Public Citizen’s petition, Sef Kurstjens, chief medical officer at Botox maker Allergan, said, “in its entire history, there has never been a single reported death where a causal link to Botox Cosmetic was established.”
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[…] The U.S. Food and Drug Administration notified the public February 8, 2008 about harmful side effects of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B). These popular, medically administered injections have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses. Dermaxin is a safe alternative to treating the unwanted signs of aging including wrinkles, frown lines and loose skin. Dermaxin’s demand has soared since consumers have been made aware of the potential risks involved with Botox or similar botulinum treatments. The adverse reactions of botulinum are related to the spread of the toxin to areas distant from the site of injection, and mimic symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems. Dermaxin provides an effective alternative that does not put consumers at risk of health related concerns. […]
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