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:4/25/2017)... , ... April 25, 2017 , ... A stressful work ... work can also decrease overall productivity and performance in the workplace. The goal of ... During the last few weeks of April, Clearview Resolution Services will be shutting down ...
(Date:4/25/2017)... ... April 25, 2017 , ... Patients who would like to ... a fraction of the time as traditional braces – Wilckodontics®. Dr. Victoria Chen, ... offers this revolutionary treatment with or without a referral. , Wilckodontics is ...
(Date:4/25/2017)... ... 25, 2017 , ... Saad B. Chaudhary, MD is committed to providing the highest quality of ... I focus on preventative care with all my patients to alleviate possible future issues. I ... free to contact my office and my trained staff will assist you in any way ...
(Date:4/25/2017)... ... April 25, 2017 , ... Amendia, ... continuation of its strategic partnership with and platinum sponsorship of Global Spine Outreach ... safe and effective management of complex spine deformity cases, particularly in children. , ...
(Date:4/24/2017)... ... April 24, 2017 , ... Ridgecrest Herbals makes it a point ... strategies to reduce waste, and support renewable energy. They believe this is a crucial ... to find solutions for health issues, and maintain that destroying the environment in the ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... , April 20, 2017  CVS Pharmacy, the ... unveiled a new store design to enhance the ... healthier food, health-focused products and expanded beauty selections ... help customers discover new offerings. Together with its ... evolution of the customer experience at CVS Pharmacy.  ...
(Date:4/20/2017)... 2017  AbbVie (NYSE: ABBV), a global biopharmaceutical ... chronic hepatitis C virus (HCV) infected patients with ... compensated cirrhosis (Child-Pugh A) achieved sustained virologic response ... its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P). These ... 12 weeks of G/P treatment without ribavirin. Patients ...
(Date:4/20/2017)... PARIS , April 20, 2017 ... EyeCET platform, the first non-viral gene expression technology that ... in the eye to address a wide range of ... UK Medicines and Healthcare products Regulatory Agency (MHRA) to ... ...
Breaking Medicine Technology: