Navigation Links
FDA Takes Closer Look at Wrinkle Treatments
Date:11/18/2008

Reports of allergic reactions, other problems have surfaced with dermal fillers

TUESDAY, Nov. 18 (HealthDay News) -- U.S. health advisers were taking a closer look Tuesday at those increasingly popular cosmetic treatments called dermal fillers that help to smooth away deep lines and wrinkles on the face.

While side effects are relatively rare, the U.S. Food and Drug Administration has received reports of allergic reactions, including some that were life-threatening, such as anaphylactic shock, the agency said.

That's why an FDA advisory panel is reviewing those reports to see if stronger warning labels are needed for the injectable products, some of which are made from natural substances, while others come from synthetic materials. Brand names for some of these products include Restylane, Juvederm, Artefill, and Perlane.

The FDA has also asked the panel to make recommendations on testing the dermal fillers, post-approval follow-up and informing consumers about potential risks. The meeting was spurred by reports of 823 injuries caused by dermal fillers that included allergic reactions, swelling, sores, pain, blisters and cysts.

The FDA isn't required to follow the recommendations of its advisory panels, but it typically does so.

More than 1 million procedures using dermal fillers took place last year, and 638 patients needed additional medical treatment. Nineteen patients were seen in emergency rooms with life-threatening allergic reactions, such as difficulty breathing. Twelve patients had to be admitted to hospitals due to infections, the FDA said.

Medications used to treat problems ranged from topical steroid creams to multiple courses of oral antibiotics, topical steroids, anti-inflammatory or antihistamine drugs, and intra-lesion steroid injections. Ninety-four of the 823 reported injuries required surgical intervention, ranging from opening an abscess for drainage of pus, to biopsy of lesions, the FDA said.

One of the FDA's concerns is that some of the products are being used in ways that they weren't approved for -- called "off-label use."

There's limited data on how darker-skinned people may react to the dermal filler treatments. Hispanic, black and Asian patients may develop blotches and other complications, the FDA said.

"Off-label" use of these products may be the cause of some of these problems. Lip enhancement is a common off-label use, the FDA said.

Another concern is what happens to the fillers as they break down and circulate throughout the body. Most of the products appear to cause no problems, but one contains small plastic balls that aren't absorbed by the body, the FDA said.

More information

For more on cosmetic surgery, visit the American Society of Plastic Surgeons.



SOURCE: U.S. Food and Drug Administration


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Economic Stress Takes Toll on Health
2. APWU Health Plan Takes Lead in Introducing New Hearing Benefit and Cap on Prescription Drug Costs
3. Heres What It Takes ... to Be Healthy, Wealthy, and Wise: New Self-Help Book Sees Life as Pieces of a Puzzle, Offers Advice on Making Those Pieces Fit
4. Coromega Unveils New Healthy Heart and CoQ10 Supplements : Revolutionary Omega-3 Supplement Company Introduces Two Fresh Takes on Heart Health and Antioxidants
5. Former Miss America Nicole Johnson Takes Action for Type 1 Diabetes Research
6. New HIV-reduction initiative takes to the fields
7. Irritable Bowel Syndrome Takes Center Stage at Yakults 17th Intestinal Flora Symposium
8. Sweepstakes Offers Viewers Chance to Win 'Your Turn to Get Exiled' Experience
9. Beware of Ten Mistakes after Social Security Denies Disability Benefits
10. Bayer Diabetes Care Names Walk In Nicks Shoes (W.I.N.S.) Sweepstakes Grand Prize Winners
11. Carmex Takes Moisture to the Next Level With New Carmex Moisture Plus(TM)
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Takes Closer Look at Wrinkle Treatments 
(Date:6/27/2016)... Overland Park, KS (PRWEB) , ... June 27, 2016 , ... ... leader in retailers of Eyeglasses . , Millions of individuals in the United ... life, eyeglasses have become a way to both correct vision and make a fashion ...
(Date:6/26/2016)... ... 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic ... World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. ... some of the world’s leading providers of cereal and other breakfast foods. Its residents ...
(Date:6/26/2016)... North Carolina (PRWEB) , ... June 26, 2016 , ... ... release of a new product that was developed to enhance the health of felines. ... for centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/26/2016)... Clarkston, Michigan (PRWEB) , ... June 26, 2016 ... ... respect to fertility once they have been diagnosed with endometriosis. These women need ... but they also require a comprehensive approach that can help for preservation of ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... Austin ... of the American College of Mohs Surgery and to Dr. Russell Peckham for medical ... and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... June 23, 2016 , , ... July 7, 2016 , , , , LOCATION: , , ... , , , EXPERT PANELISTS:  , , , Frost & ... Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, ... The global pharmaceutical industry is witnessing an exceptional era. Several new ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of Astellas Farma ... as the company,s second affiliate in Latin America . ... ... Astellas Farma Colombia ... ...
(Date:6/23/2016)... -- Guerbet announced today that it has been named a ... One of 12 suppliers to receive the ... of Premier members through exceptional local customer service and ... lower costs. "We ... customer service from Premier," says Massimo Carrara , ...
Breaking Medicine Technology: