With millions of men and women receiving Botox injections to fight the effects of aging, the Food and Drug Administration (FDA) wants a new warning to help prevent serious personal injury in Florida and throughout the U.S.
A report states that Botox (Trademark name of Allergan) and similar anti-wrinkle drugs must carry stringent warning labels, such as a black box warning, the most serious issued by the agency, and a Risk Evaluation and Mitigation Strategy (REMS).
There is some concern that Botulinum toxins may spread from the injection area to other areas of the body causing symptoms similar to those of botulism, including trouble of breathing, trouble swallowing, blurred vision and various other adverse effects. Let’s not forget that Botulinum toxins are purified forms of botulism that work to temporarily reduce or stop muscle activity.
The FDA says these effects are rare, but have occurred in children when used to help relax uncontrollable muscle movements.
This new action for black-box warnings was spurred by a petition from the watchdog group, Public Citizen, which has had its eye on Botox and its product liability for awhile. FDA records show there were more than 650 adverse events from Botox injections from 1989 to 2006. Problems included pneumonia, fluid in the lungs, and 16 deaths.
Allergan says it will work with the FDA to update its label for Botox and Botox cosmetic products. Other products are: Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences; and a new FDA-approved product, Dysport (abobotulinumtoxinA), marketed by Ipsen Biopharm Ltd.
If you have been injured by a cosmetic procedure that was supposed to improve your life, you will need the help of an experienced Florida medical malpractice attorney at Farah and Farah who understands the background on these cases.
Botox has been the subject of some questions for awhile and with this new warning, it merits a second look by the medical establishment, consumers, the law and the federal regulatory system that is supposed to keep us safe.