FDA Panel Says Wrinkle Fillers Should Carry Stronger Warnings

By Anna Boyd
15:00, November 19th 2008
17 votes
Vote this story
FDA Panel Says Wrinkle Fillers Should Carry Stronger Warnings

Labels of popular cosmetic wrinkle fillers should carry stronger warnings about potential side effects, according to an advisory panel of the Food and Drug Administration.

The panel met Tuesday in Gaithersburg, Maryland, to discuss the safety of wrinkle fillers and whether new warnings are needed.

The member of the panel agreed that, “the labeling should be revised to include the more serious adverse events and how long the product has been on the market and how long it might take events to appear,” Siobhan DeLancey, an FDA spokeswoman who was at the meeting, said.

Current labels of the products are inadequate reading only immediate and temporary side effects such as swelling.

The decision follows an FDA review posted on the agency’s Web site. According to it, more and more people using wrinkle fillers experience medical problems later. A total of 930 reports of health problems have been received over the past six years (from January 2003 to September 20th of this year). Side effects include facial palsy and disfigurement and rare, but life-threatening problems such as severe allergic reactions and anaphylactic shock.

Among the reports, 19 were from people admitted to the emergency room for severe allergic reactions, 638 patients required treatment with medication, which included steroids, antihistamines and oral antibiotics. Also, 94 patients required surgical intervention (opening the abscesses, excision of nodules and biopsy of lesions), which included 44 that had also received drug therapy. The other reports did not include specific treatments for conditions.

The panel’s decision, if approved by the FDA, would affect such manufacturers as Allergan Inc., Sanofi-Aventis SA, Medicis, Artes Medical Inc., and BioForm Medical Inc.

Overall, about 1.36 million women and 84,000 men received the injections last year, primarily for cosmetic reasons, but they are also given to HIV patients to counteract a gaunt look. According to the American Society for Aesthetic Plastic Surgery, non-surgical cosmetic procedures increased more than eightfold between 1997 and 2007.



© 2007 - 2009 - eFluxMedia
dotclear

Other News in

Gene Predicts the Likelihood of ALL Recurrence

Gene Predicts the Likelihood of ALL Recurrence

  Acute lymphoblastic leukemia or ALL is the most common type of cancer in children affecting about one in 30,000 each year. Current drugs for the disease have put the cure rates close to 80...

Teens Tackle Risky Behaviour on MySpace

Teens Tackle Risky Behaviour on MySpace

Many teens and college students enjoy talking about sex, drugs and violence on MySpace or Facebook, a new study shows. But they are disposed to change their risky behaviour if they are given the...

Salmonella Outbreak Continues to Spread in More Countries

Salmonella Outbreak Continues to Spread in More Countries

Ohio health officials have announced at least 50 people in 18 countries have been sickened by salmonella bacteria in the most recent salmonella outbreak. The last case reported in Ohio was Dec. 12....

FDA: New Drug from Genetically Engineered Goats May Be on Its Way

FDA: New Drug from Genetically Engineered Goats May Be on Its Way

The Food and Drug Administration revealed Wednesday that for the first time an anti-clotting drug made from the milk of genetically engineered goats works and its safety is acceptable.   The...

FDA Refuses to Approve Lilly’s Long-Acting Zyprexa

FDA Refuses to Approve Lilly’s Long-Acting Zyprexa

The US Food and Drug Administration refused to immediately approve a long-acting formulation of schizophrenia drug Zyprexa requesting its maker details regarding its risks.   Eli Lilly &...

dotclear
Latest videos in Health
Plastic Bags Help to Save...
Nuclear knuckles
Restoring the pee-h balance
Bird flu alert in Hong Kong
Ireland in pork product alert

dotclear
Health You are here: Health
» Science   » Health   
E-mail To A Friend Print RSS Text size: Decrease font size Increase font size
dotclear
dotclear
dotclear
Most Popular in Health
UAMS Scientists To Begin Testing Breast Cancer VaccineUAMS Scientists To Begin Testing Breast Cancer Vaccine

» read full story
dotclear

Interested In This Topic?

News Alert will keep you informed. Find out more.
dotclear
Photos Gallery
dotclear
Today's Latest News
Brad Pitt Comes Clean about Relationships with Jolie and AnistonBrad Pitt Comes Clean about Relationships with Jolie and Aniston

» read full story
dotclear