Botox Treatments May Endanger Children

June 30, 2009

The Food and Drug Administration has placed a "black box" warning on the use of Botox and related products.

June 30, 2009 /24-7PressRelease/ -- Botox Treatments May Endanger Children

Article provided by Steinberg, Goodman & Kalish, please visit us at http://www.sgklawyers.com

Many people are confused and concerned over recent reports that the Food and Drug Administration has placed a "black box" warning on the use of Botox and related products. Increasing numbers of people have availed themselves of Botox treatment for cosmetic purposes with pleasing results. When administered by a licensed health practitioner in an office setting, this has proved to be relatively safe, although unfavorable reactions have occurred even during cosmetic use.

The black box warning is of particular concern to parents of children suffering from cerebral palsy, as botulism toxin-related injections have been a promising treatment option for those with limb spasticity. Although therapies using these drugs have been encouraging, there have been many adverse reactions and several deaths related to its use.

Children suffering from cerebral palsy often struggle with severe lower extremity spasticity. Botulism toxin injections were found to be helpful in treating the spasm because the protein, botulinum toxin A, prevents the release of acetylcholine, the compound that transmits signals between the muscles and the nerves. When injected, this botulism extract relaxes muscles, relieving the spasms. Relief from spasms is helpful in making strides in physical therapy and strengthening muscles. Although this is the same drug used for wrinkle-relief, the dosages used for cerebral palsy patients are considerably higher than those used for cosmetic purposes.

Although the therapy has shown promise, researchers have become aware that there are many unfortunate reactions, chiefly among children, to the toxin itself. Recently, the watchdog group Public Citizen petitioned the FDA to issue a stronger warning against use of the therapy among young children. This petition resulted in the new black box warning. Botulism toxin has never been FDA-approved for use in treating spasticity for patients under the age of twelve. Some countries in Europe do approve the drug for use in pediatric patients, but these usually include strongly-worded warning information to doctors.

To date, at least sixteen deaths have been attributed to the use of botulism therapy, four of them in children. One of the problems uncovered is that the dosage per unit of various botulism products varies widely; a less-than-alert practitioner could easily administer a fatal dose when using an alternate product. At least one death has been recorded due to systemic botulism from a severe overdose of injected toxin.

Due to the stronger dosages used in spasticity treatment, there is a danger of migration of the toxin from the injection site to other areas of the body. These adverse reactions have been reported from several hours to several weeks after injection. The side effects, other than systemic botulism, that have been described by the FDA include drooping eyelids, muscular weakness, difficulty breathing, difficulty swallowing, aspiration pneumonia, constipation, loss of bladder control, facial drooping, speech disorder, double vision, respiratory depression and infection at the site of the injection. Serious case reports include hospitalizations requiring ventilator support.

The FDA is now requiring a bold black box warning on Botox, Myobloc and related botulinum toxin products. Parents of children with cerebral palsy should expect their physician to fully discuss the dangers associated with these products prior to treatment so that they can make a fully-informed decision whether or not to use the therapy.

In the event that your or child has been harmed by an injurious reaction to botulinum toxin A, a competent attorney can help you determine your best options for continued care and potential monetary recovery. Legal counsel knowledgeable in adverse reaction reporting, negative effects and standards of practice can help obtain the best outcomes, for yourself or your child.

Source: Steinberg, Goodman & Kalish
Website: http://www.sgklawyers.com



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