Join our RSS Feed
Pages
Categories
- Botox
- Breast Augmentation
- Breast Reduction
- Celebrity Plastic Surgery
- Cosmetic Surgery News
- Definitions
- Dr. 90210
- Featured Cosmetic Surgeons
- Liposuction
- plastic surgeon
- Plastic Surgery
- Plastic Surgery Costs
- Plastic Surgery Risks
- Rhinoplasty
- Tummy Tuck
- Uncategorized
- Video
Blogroll
- Breast Implants Information
- Cosmetic Dentistry Information
- Cosmetic Surgery Insider
- Facial Fillers Information
- Plastic Surgery Costs
- Plastic Surgery Financing
- Plastic Surgery Glossary
- Porcelain Veneers Information
- Restylane Information
- Tummy Tuck Information
Archives
Author: William
~ 05/07/09
When it was first discovered a year ago about surprising new evidence that Botox and other drugs containing the neurotoxin botulinum could travel from the site of injection to the brain, it wasn’t clear whether this posed a threat to patients (the study cited described was done on lab animals).
Earlier this week however, the Food and Drug Administration announced that the risk was all too real: effective immediately, the FDA will now require Botox, Myobloc and all other botulinum treatments to carry what is known as a “black box warning” — the strongest FDA warning of record — alerting doctors and patients alike that the toxin can spread to distant parts of the body, well enough away from the injection site(s), posing serious risks such as trouble breathing and swallowing.
The FDA is also requiring manufacturers to send doctors and all other licensed practitioners a letter warning of the risk.
The action comes in response to a petition from Public Citizen, which in 2008 asked FDA to require both a black box and the warning letters. Initially, it was expected that FDA would have limited the warnings to non-cosmetic uses of the drugs, since that’s where most of the problems with adverse side effects had occurred (Editors note: botulinum is used to treat cervical dystonia, eyelid spasms and a few other medical conditions in addition to cosmetic applications such as treating frown lines), especially in unapproved uses such a limb spasticity in children with cerebral palsy.
But the administration said it found 225 cases in which the drug had migrated beyond the injection site, sometimes as far as to deep internal tissue. That was alarming enough to justify the black-box decision, even on cosmetic Botox.
According to the FDA, “there is insufficient information to fully characterize the safety profile and potential risk factors for spread of botulinum toxin at this time, given that the mechanism by which spread may occur has not been confirmed…Based on available information, it is not possible to precisely predict the role of injection site, injection technique, or dose in the spread of toxin or severity of the event. Therefore, we are seeking safety labeling changes for the both the dermatologic and neurologic indications.”
