켐론FDA코리아

FDA Warms About Lipodissolve Product Claim 

지방분해주사의 FDA 경고

FDA는 지방을 분해한다는 주사를 이용하는 환자들에게 주의를 당부했습니다. 미국 내에서 lipoysis, lipozap, lipotherapy, mesotherapy 등의 이름으로 지방을 분해해 살을 빼는 치료법으로 소개되고 있는데 이때 사용하는 약품은 포스파티딜콜린(phosphatidyl choline) 즉, PPC와 디옥시콜레이트 (deoxycholate)입니다. FDA의 Director Janet Woodcock (FDA CDRH Director)은 몇몇 생산자가 소비자를 잘못 인도 하고 있는 것에 우려한다고 했으며, 지방을 분해시키는 목적으로 이들 제품을 승인한 적이 없다고 밝혔습니다. 


       □     소비자가 반드시 알아야 할 사항 

      •       지방분해용으로 FDA가 승인한 제품이 아님

•       이들 제품이 지방제거에 얼마나 효과적인지 검증 안됨

•       이 성분들을 단독 또는 복합으로 사용하는 것에 대한 안전성에 대해 잘 모름

•       지방 분해를 위한 의약품으로 사용하는 것에 대한 임상연구가 부족

       □     약물 주사와 관련된 부작용

•       영구적인 흉터

•       피부 변형

•       지방 분해 주사를 맞은 자리에 깊고 아픈 상처 발생

FDA Warns About Lipodissolve Product Claims 
 

It's a tempting premise: Get a series of drug injections and see pockets of fat on your body go away for good.

But the Food and Drug Administration (FDA) is alerting consumers about false and misleading claims being made about products used in lipodissolve, and about other misbranding of these products.

Recipients of lipodissolve get a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body. The process is also known as injection lipolysis, lipozap, lipotherapy, and mesotherapy.

“We are concerned that these companies are misleading consumers,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by FDA for fat removal.”

The drugs most regularly used in the lipodissolve injection regimen are phosphatidylcholine and deoxycholate (commonly called PC and DC, respectively). Other ingredients may also be used, including drugs or components of other products such as vitamins, minerals, and herbal extracts.

What Consumers Should Know FDA is alerting consumers that it has not evaluated or approved products for use in lipodissolve it is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination the safety of these substances, when used alone or in combination, is unknown it is not aware of clinical studies to support medical uses of lipodissolve In addition, FDA has reports of unexpected side effects in people who’ve undergone the lipodissolve procedure. These side effects include permanent scarring skin deformation deep, painful knots under the skin in areas where the lipodissolve treatments were injected

출처 : www.fda.gov/consumer