FDANews.com

"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." Continue Reading…

DailyBeauty.com
At the end of July, the much-anticipated filler Elevess, from Anika Therapeutics, received FDA approval for commercial sale.  Like other hyaluronic-acid injectables, it is expected to be used by dermatologists and cosmetic surgeons for improving the appearance wrinkles and scars.  However, Elevess does have two distinct differences.  First, Elevess has the highest concentration of cross-linked hyaluronic acid of any commercially available dermal filler.  Because of this, experts expect longer-lasting results.  Second, Elevess has lidocaine, a local anesthetic, right in its formula—it’s the first and only available aesthetic filler to do so. Anika says this will vastly improve patient comfort. and satisfaction.  Do these differences make Elevess a more appealing option for you? Let us know your thoughts and plans by leaving a comment below.

abc7news.com

A new wrinkle filler is creating quite a buzz for those trying turn back the clock. For the first time, a product is claiming it can erase certain lines permanently.  Patti Cook, Facial Filler Patient: "What I don’t like are the wrinkles and creases in my face."  Patti Cook is typical of many women, looking for a more youthful appearance without surgery.  Patti Cook: "It would be nice to be 5 or 10 years younger."  She’s especially interested in erasing the creases going from her nose to her lips.  In the last several years, there’s been an explosion of facial fillers receiving FDA approval.  Products like Juvederm and Restylane could help Patti plump her creases.  But typically these fillers last only six to eight months and that means the user needs to get shots once or twice a year to maintain that effect.  But that may all be changing with a new filler called Artefill which claims to be permanent.  Read More / Watch Segment

MedicalNewsToday.com
Stiefel Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Extina(R) (ketoconazole) Foam, 2% for the treatment of seborrheic dermatitis. The approval, which the company received June 12, clears the way for the product to be sold and marketed in the United States. Read More

The following from FDA News: 

The U.S. Food and Drug Administration (FDA) today warned consumers to avoid using tubes of toothpaste labeled as made in China, and issued an import alert to prevent toothpaste containing the poisonous chemical diethylene glycol (DEG) from entering the United States.

DEG is used in antifreeze and as a solvent.

Consumers should examine toothpaste products for labeling that says the product is made in China. Out of an abundance of caution, FDA suggests that consumers throw away toothpaste with that labeling. FDA is concerned that these products may contain "diethylene glycol," also known as "diglycol" or "diglycol stearate."

Continue Reading…

This release, via WebMD

"The FDA has approved a new wrinkle filler called Perlane for the treatment of moderate to severe facial folds and wrinkles.  Perlane is made by Medicis, which also makes the wrinkle filler Restylane.  Both products contain hyaluronic acid. 

"The primary difference between Restylane and Perlane is that the hyaluronic acid gel particles in Perlane are larger than those found in Restylane," says Medicis in a May 2 news release announcing the drug’s approval.  Medicis says Perlane’s larger gel particles can reach the deep layers of the skin, offering "enhanced volume and lifting power."  Perlane has been used safely by dermatologists and plastic surgeons since 2000 outside the U.S.," says Medicis.

Note:  Perlane should only be administered under the supervision of a licensed practitioner.  The effects last for about six months, according to Medicis, which says it will begin shipping Perlane in the next 30 days."

According to the American Society of Aesthetic Plastic Surgeons (ASAPS), 5.7 million injectable procedures were performed last year for cosmetic purposes.  These FDA approved injections treat facial wrinkles, combat signs of aging and help diminish skin imperfections.  The ASAPS, the American Academy of Facial Plastic and Reconstructive Surgery, and the American Society for Dermatologic Surgery have formed an alliance known as the Physicians Coalition for Injectable Safety.  The Coalition recently announced a public awareness campaign on the safe use of injectable treatments.  "We are concerned that troubling reports and requests for help from patients hurt by counterfeit or so-called ‘off-shore’ injectables or by untrained injectors are growing," said Mark L. Jewell, MD, Chair of the Coalition and past president of the American Society for Aesthetic Plastic Surgery (Medical News Today).

Continue Reading…

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