Botox Injections Information
Botox and Myobloc - FDA Alert Warning.
FDA NEWS UPDATE February 8, 2008
FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses.
The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. See the FDA's "Early Communication about an Ongoing Safety Review" for Agency recommendations and additional information for healthcare professionals.
Read the complete 2008 MedWatch Safety Summary including a link to the FDA's Early Communication about an Ongoing Safety Review regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#botox
Botox Recent Studies and Statistics:
Recent statistics have shown that the Botox treatment industry has generated over $1 billion per year in revenue. When an industry hits that threshold, it’s basically arrived as a viable market. Botox is seen as a viable option for many who are looking to defy nature’s law of aging, and it’s generally a quick and easy process of what usually involves an injection or set of injections that slow down the wrinkling process.
However, recent reports have surfaced that have drawn an unpleasant light onto this alleged ‘miracle’ substance, and the situation now could proceed along several pathways. Below is a brief look at Botox and the problems it’s encountered, but if you have been injured or are experiencing any side effects, seek immediate medical attention and then contact a defective products attorney to schedule an initial consultation.
Botox Brands Allergan Inc. and Solstice Neuroscience Inc.
The brands in question were from two separate companies, Allergan Inc's Botox and Solstice Neuroscience Inc's Myobloc. Each of these companies separately is a corporate giant, and each is quite aggressive in its marketing and overall positioning efforts, thereby exposing these brands to more people who could be at risk.
Request to FDA for Black Box Warning for Botox
The controversy began when one of the most well-known consumer watchdog groups made a request to the Food and Drug Administration (FDA) to require the addition of a “Black Box” warning to the labels of these brands of Botox. The group in question is Public Citizen, which is a general consumer advocacy group that was founded in 1971 by Ralph Nader, one of the most widely-known consumer advocates in the world.
Public Citizen decided to take action after reviewing 180 reports that were sent to the FDA regarding patient problems with these brands of Botox, and aside from the plethora of serious side effects, including paralysis and aspiration pneumonia, 16 people were killed after using these products. Of those 16 deaths, four patients were under the age of 18.
Help for Botox Victims.
If you or someone you love has used Botox and are experiencing any side effects whatsoever, seek an immediate and full medical evaluation. If your diagnosis includes an injury as a result of exposure to this substance, your next step should be to contact a defective products attorney as soon as possible to schedule an initial consultation. You have legal rights and options that need to be explored and, if advisable on the basis of your attorney’s recommendations, forcefully asserted.