WEST PALM BEACH, Fla. - There's bad news about Botox, if you believe the nonprofit consumer advocacy group, Public Citizen. Most of us thought we had heard all the controversy about the drug, made from botulinum toxin and sold as both Botox and Myobloc, including the faux Botox scandal in Palm Beach County that concluded in 2006 with jail time for the doctor who injected a Palm Beach Gardens couple with fake serum.
Botox is used to smooth out wrinkles, temporarily, although it has medical uses, as well, including correcting drooping eyelids and excessive sweating.
But, Public Citizen says in a petition to the U.S. Food and Drug Administration, doctors and patients are unaware of documented adverse reactions, including deaths, linked to the drug, and more prominent warnings should be displayed with the packaging.
In some cases, Public Citizen says in its petition, the toxin has spread to other parts of the body, causing paralysis of respiratory muscles and difficulty swallowing (dysphagia), the latter possibly leading to food or liquids entering the respiratory tract and lungs, causing aspiration pneumonia.
"A Public Citizen analysis of FDA data found that makers of the drug have reported 180 U.S. cases of people developing these sometimes life-threatening conditions after receiving injections, including 16 deaths," Public Citizen claims.
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The agency isn't asking that Botox be taken off the market, only that, "The FDA should send a warning letter directly to doctors alerting them to the problems associated with the toxin, including cases of hospitalization and death."
The agency is also asking for strong warning labels, and that doctors be required to give patients a medication guide at the time of the injection, warning them of possible symptoms of adverse reactions, as well as other information about the drug.
