FDA Warnings and Recalls
BOTOX
Botox is an alternative to cosmetic surgery that many people use (including high profile celebrities) to enhance their beauty by minimizes the signs of aging. The first person I thought about was “Ugly Betty” Vanessa Williams when I started reading about this warning since I just recently posted an article about how much she loves receiving botox treatments.
Back in February the FDA issued a warning (after several deaths occurred) against the use of Botox which contains 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. According to the FDA the most serious cases 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.
These serious systemic adverse reactions occurred following treatment of a variety of conditions using a wide range of botulinum toxin doses. FDA is currently reviewing safety data from clinical studies submitted by the manufacturers of Botox, Botox Cosmetic and Myobloc, as well as post-marketing adverse event reports and the medical literature.
In a more recent study, published April 2 in the Journal of Neuroscience, researchers raises the concern that the popular anti-wrinkle treatment Botox may in fact travel from its injection site into the brain. For the study, researchers injected botulinum toxin (the active ingredient in Botox) into the whisker muscles of rats. Researchers then looked at the connected brain areas for signs of the toxin. Within three days of the injection, they found remnants of a protein broken down by the toxin in an area of the brainstem. The toxin also moved from one hippocampus, which controls long-term memory and spatial navigation, to the hippocampus on the opposite side of the brain, and from the superior colliculus, the part of the brain associated with eye-head coordination, back to the eye. The study found that brain cell activity was disrupted both where botulinum neurotoxin was injected and in some of the distant-but-connected sites.
The study’s author, Matteo Caleo of the Italian National Research Council’s Institute of Neuroscience in Pisa, called the finding a concern and noted that the effects of the botulinum injection on the hippocampus were still present six months later. He said more work is needed to better understand how the toxin spreads along nerves and how to prevent the spread or use it therapeutically.
So what exactly does all this mean? After all these years, is Botox all of a sudden being looked at as a major cause of death? Hummmmm
EYELASH CONDITIONERS
Long eyelashes are among the list of the hottest make-up trends for the spring/summer 2008. While everyone loves long, pretty eyelashes are they worth going blind?
I’ll have to admit that my eyes got big when I read about the new eyelash conditioner on the market today that sooooo many consumers are actually raving about. I was excited to learn more about this miracle product that claims to make your natural eyelashes grow long and full in just a matter of months. So long that you feel them rubbing up against your eye glasses.
Well, to my disappointment I came across yet another FDA announcement, this time it wasn’t just a warning, but an actual recall. However, don’t be a fool, the product is still on the market being sold around the globe right now as I speak. A big question I have is why was this product recalled and botox just received a warning? Is there a $ figure factor involved???
Dated November 16, 2007
Approximately $2 Million of Potentially Harmful “Cosmetic” Eye Product Seized
Product contains drug ingredient, makes unapproved drug claims, could damage eye
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized today 12,682 applicator tubes of Age Intervention Eyelash, a product that may, in some users, lead to decreased vision. Authorities said the sales value of the seized tubes is approximately $2 million.
Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research, Inc., of San Jose, Calif.
The FDA considers Age Intervention Eyelash to be an unapproved and misbranded drug because Jan Marini Skin Research has promoted the product to increase eyelash growth. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA. The agency takes seriously its responsibility to protect Americans from unapproved drugs.
FDA also considers the seized Age Intervention Eyelash to be an adulterated cosmetic. The product contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye).
For patients using the prescription drug, using the Age Intervention Eyelash in addition to the drug may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug’s effectiveness. Damage to the optic nerve may lead to decreased vision and possibly blindness.
In addition, use of Age Intervention Eyelash may cause other adverse effects in certain people due to the bimatoprost, including macular edema (swelling of the retina) and uveitis (inflammation in the eye), which may lead to decreased vision.
The U.S. Attorney’s Office for the Northern District of California filed the complaint requesting the seizure, and coordinated with the FDA. The California Department of Public Health‘s Food and Drug Branch had previously embargoed the seized products at the San Jose facility. Jan Marini Skin Research has notified FDA that the company ceased manufacturing and shipping any Age Intervention Eyelash product containing bimatoprost last year.
The FDA recommends that consumers, dermatologists, and estheticians who may still have Age Intervention Eyelash discontinue using it and discard any remaining product. FDA also recommends that consumers consult their health care provider if they have experienced any adverse events that they suspect are related to the product’s use.
UPDATE: Since this recall, the company has supposedly stopped selling the original product which contained the drug used for glaucoma and replaced it with the same product that doesn’t contain the same ingredient.
I have read several reviews of the product, most of which are very satisfied consumers who claim the product really works. A few report that it doesn’t work and that after continued use it still causes eye irritation. Some also report that once they stop using the product, their eyelashes return to their normal state.
Shu Uemura Luxury False Eyelashes at Sephora.com
