December 8, 2008  

 January 26-30

 Wailea Marriott Resort and Spa

 

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New Products Bring Side Effect: Nanophobia

 

 

By NATASHA SINGER

Published: December 3, 2008

 

IT sounds like a plot straight out of a science-fiction novel by Michael Crichton. Toiletry companies formulate new cutting-edge creams and lotions that contain tiny components designed to work more effectively. But those minuscule building blocks have an unexpected drawback: the ability to penetrate the skin, swarm through the body and overwhelm organs like the liver.

 

Humans have long lived in dread of such nightmare scenarios in which swarms of creatures attack. Alfred Hitchcock envisioned menacing flocks in "The Birds." In the 1990 film "Arachnophobia" a killer spider arrives in the United States, where it attacks and multiplies.

 

And now comes nanophobia, the fear that tiny components engineered on the nanoscale -- that is, 100 nanometers or less -- could run amok inside the body. A human hair, for example, is 50,000 to 100,000 nanometers in diameter. A nanoparticle of titanium dioxide in a sunscreen could be as small as 15 nanometers. (One nanometer equals a billionth of a meter.)

 

"The smaller a particle, the further it can travel through tissue, along airways or in blood vessels," said Dr. Adnan Nasir, a clinical assistant professor of dermatology at the University of North Carolina at Chapel Hill. "Especially if the nanoparticles are indestructible and accumulate and are not metabolized, if you accumulate them in the organs, the organs could fail."

 

http://www.nytimes.com/2008/12/04/fashion/04skin.html?_r=1&ref=science&pagewanted=all

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FDA Faults Wrinkle Fillers Over Warnings

 

November 19, 2008

 

By JENNIFER CORBETT DOOREN

 

WASHINGTON -- Product labels on popular cosmetic wrinkle fillers should be strengthened to warn consumers about scarring and other problems that can crop up weeks or years after receiving the treatments, a Food and Drug Administration panel said Tuesday.

 

The panel said current product labels on fillers approved to plump certain facial lines are inadequate and only discuss immediate and temporary side effects, such as swelling. While an FDA review of reported adverse events associated with dermal fillers showed many expected side effects like temporary swelling and redness, the agency said "there are a number of adverse events that are serious and unexpected."

 

The agency is considering whether to boost warnings on product labels and require manufacturers to conduct longer and larger studies to be submitted as part of product approval applications. The FDA says it expects more pre-market applications to be submitted for approval of products to fill wrinkles because of growing consumer demand for those products, along with applications for new uses like treating lips, the chin and other parts of the body.

 

http://online.wsj.com/article/SB122704232180438447.html

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FDA Panel Ayes Eyelash-Boosting Drug

 

FDA Advisory Committee Recommends Approval of First Prescription Eyelash Enhancer Latisse

 

By Miranda Hitti

WebMD Health News

 

Dec. 5, 2008 -- An FDA advisory panel today recommended approving Latisse, a drug to promote longer, thicker, darker eyelashes.

 

Latisee is a spin-off of the glaucoma drug Lumigan. The FDA approved Lumigan in 2001 as an eyedrop. Eyelash growth is a known side effect of the drug.

 

AllerganInc., the drug company that makes Lumigan, studied the drug to see how well it promoted eyelash growth, thickness, and darkness when dabbed like an eyeliner at the roots of the eyelashes on the upper eyelid.

 

In that study, 137 people used Latisse and 141 people used a placebo solution for 16 weeks. The result: Thicker, longer, darker eyelashes were more common by the end of the study in the Latisse group. And people in the Latisse group reported more satisfaction with their lashes than people who used the placebo.

Side effects, which were generally temporary and mild, included eye redness, which stopped when the use of the drug was discontinued, according to Allergan documents submitted to the FDA.

 

Lumigan's prescribing information notes that the drug may darken eyelid skin and gradually increase pigmentation of the iris, making eyes browner. Those iris color changes, which may not be noticeable for several months to years, may be permanent but don't progress after stopping Lumigan.

 

The Latisse study, however, doesn't report any cases of iris color changes. Unlike Lumigan, Latisse isn't meant to go directly on the eyes, and each Latisse dose uses only 5% of a Lumigan drop.

 

The FDA panel also recommended further studies to assess Latisse's use in certain groups of patients, such as young patients and people who lost their eyelashes because of chemotherapy, according to an Allergan news release.

 

http://www.webmd.com/skin-beauty/news/20081205/fda-eyes-eyelash-boosting-drug?src=RSS_PUBLIC

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