FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedure

Drug Information Update: FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedure

The U.S. Food and Drug Administration today issued warning letters to six U.S. based medical spas and a company in Brazil for making false or misleading statements on their Web sites about drugs they claim will eliminate fat in a procedure called “lipodissolve,” or for otherwise misbranding lipodissolve products.

The U.S. companies involved have made claims that the drugs they use for their lipodissolve procedures are safe and effective; however, these products have not been evaluated or approved by the FDA for this use.

Lipodissolve is a procedure involving a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body. It also is known as mesotherapy, lipozap, lipotherapy, or injection lipolysis. The most commonly injected drugs are phosphatidylcholine and deoxycholate, usually in various combinations with one another.

The FDA is requesting a written response from the U.S. companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future. Each U.S. company has been informed in its warning letter that failure to promptly correct the violations may result in legal action.
For more information please visit: Lipodissolve

FDA NEWS RELEASE
For Immediate Release: April 7, 2010
Media Inquiries: Tom Gasparoli, 301-796-4737, thomas.gasparoli@fda.hhs.gov,
Consumer Inquiries: 888-INFO-FDA

FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedure
Agency says false or misleading statements made in touting of ‘lipodissolve’ products

The U.S. Food and Drug Administration today issued warning letters to six U.S. based medical spas and a company in Brazil for making false or misleading statements on their Web sites about drugs they claim will eliminate fat in a procedure called “lipodissolve,” or for otherwise misbranding lipodissolve products.

The U.S. companies involved have made claims that the drugs they use for their lipodissolve procedures are safe and effective; however, these products have not been evaluated or approved by the FDA for this use.

Lipodissolve is a procedure involving a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body. It also is known as mesotherapy, lipozap, lipotherapy, or injection lipolysis. The most commonly injected drugs are phosphatidylcholine and deoxycholate, usually in various combinations with one another.

In some cases, other ingredients, including drugs or components of other products such as vitamins, minerals, and herbal extracts are added to the mixture. The FDA is not aware of any credible scientific evidence that supports the effectiveness of any of these substances for fat elimination, and their safety when used alone or in combination is unknown.

The FDA is requesting a written response from the U.S. companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future. Each U.S. company has been informed in its warning letter that failure to promptly correct the violations may result in legal action.

Each of the companies involved has been cited for a variety of regulatory violations, including making unsupported claims that the products have an outstanding safety record and are superior to other fat loss procedures, including liposuction. Additionally some of the letters indicate that the companies have made claims that lipodissolve products can be used to treat certain medical conditions, such as male breast enlargement, benign fatty growths known as lipomas, excess fat deposits and surgical deformities. The FDA is not aware of clinical evidence to support any of these claims.

“We are concerned that these companies are misleading consumers,” said Janet Woodcock, M.D., director of the 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 the FDA for fat removal.”

The FDA has received reports of adverse effects in persons who have had the procedure using these drugs, including permanent scarring, skin deformation, and deep painful knots under the skin in areas where the lipodissolve products have been injected.

The warning letters were issued to the following U.S. companies: Monarch Medspa, King of Prussia, Pa; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn.; PURE Med Spa, Boca Raton, Fl.; and All About You Med Spa, Madison, Ind. The Brazilian company receiving a warning letter markets lipodissolve products on two Web sites: zipmed.net and mesoone.com.

The FDA will notify regulatory authorities in Brazil of this action. The agency has issued an import alert against the zipmed.net and mesoone.com entities to prevent the importation and distribution of unapproved lipodissolve drug products into the United States. Importing and distributing unapproved drug products is a violation of the Federal Food, Drug, and Cosmetic Act.
Health care professionals and consumers may report serious adverse events (side effects) or quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone.


• Online: MedWatch1
• Regular Mail: use postage-paid, pre-addressed Form FDA 35002. Mail to address on the pre-addressed form.
3• Fax: 800-FDA-0178
4• Phone: 800-332-1088


For more information:

Warning Letters5
Qs&As6
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm207453.htm

FDA Information on Lipodissolve
On April 7, 2010, the U.S. Food and Drug Administration issued warning letters to six U.S. medical spas (cosmetic medical businesses that operate under the supervision of a licensed health care professional) that they are making false and misleading claims about their lipodissolve products. Lipodissolve, also known as lipozap, lipotherapy, mesotherapy, or injection lipolysis, is a cosmetic procedure that involves a series of injections over a period of months with the intention of dissolving pockets of fat in the body.

The false and misleading claims about these lipodissolve products include statements that they eliminate unwanted fat, have an outstanding safety record, and are superior to other fat loss procedures. Some medical spas also claim that lipodissolve products can treat medical conditions, such as male breast enlargement, benign fatty growths, and surgical deformities. FDA is not aware of any credible scientific evidence to support any of these medical uses.

In addition to the actions, the FDA also issued a letter to the Brazilian firm Zipmed Mesoone for selling unapproved lipodissolve products directly to consumers over the internet, and an import alert was also issued to prevent the distribution and importation of lipodissolve drug products into the United States.

Those companies that do not adequately address the violations stated in the warning letters risk further enforcement action, including injunctions that prevent additional violations and seizure of violative drugs.

Below is some additional information on lipodissolve and the actions FDA is taking.



Q: What drugs are used in lipodissolve procedures?

A: The main ingredients typically used in the lipodissolve cosmetic procedures are phosphatidylcholine (PC) and deoxycholate (DC). Neither PC nor DC are approved drugs in the United States to eliminate fat. Any claim that PC or DC is being used "off-label" for a lipodissolve procedure is false.

Lipodissolve products may also contain other substances, including pentoxifylline, lidocaine, aminophylline, calcitonin, isoproterenol, caffeine, vitamins, minerals, and herbal extracts. The safety and effectiveness of PC, DC, or the combination of these two substances when used alone or in combination with other ingredients for fat elimination is unknown.



Q: Are there any FDA-approved drugs for use in lipodissolve procedures?

A: There are currently no FDA-approved drugs for injection for fat elimination. FDA cannot assure the safety and efficacy of these types of drugs.



Q: What are the safety concerns associated with lipodissolve products?

A: The overall safety of lipodissolve products is not known. There are reports in the scientific literature of complications and adverse effects ranging from injection-site reactions (e.g., prolonged swelling, redness, pain), skin reactions (e.g., panniculitis, ulceration, abscess, necrosis, scarring) and skin infections. These adverse events may be attributed to the drugs injected, injection technique, or the formulation of the solution.

The FDA has also received several reports of adverse events through the MedWatch program in persons who have had the procedure using these drugs, including permanent scarring, skin deformation, and deep painful knots under the skin in areas where the lipodissolve treatments have been injected.

There is concern regarding unknown interactions between the various combinations of drugs used in lipodissolve procedures and maintenance of sterility of these injectable products.In addition, there is a lack of standardized formula and protocol for the injection of lipodissolve products in cosmetic procedures.

Medical professionals and organizations, including the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) have also issued position statements regarding lipodissolve that raise the following important concerns: (1) amount of fat that is dissolved; (2) problems that might evolve from injecting an uncontrolled amount of PC into subcutaneous tissue; and (3) short- and long-term adverse effects.



Q: How widespread is the marketing of lipodissolve products for cosmetic procedures?

A: Lipodissolve products are used in cosmetic procedures throughout the United States. Many medical spas have established internet websites to promote and offer lipodissolve products for cosmetic procedures. However, it is impossible to know the volume of drug products used in lipodissolve procedures. Pharmacies or medical spas are generally not required to register with FDA, or to report the products they produce or use.



Q: What should a patient do if they experience an adverse event associated with lipodissolve products?

A: Anyone who received or is currently receiving injectable lipodissolve products for cosmetic procedures should report any complaints or adverse events to MedWatch, the FDA's voluntary reporting program, by calling 800-FDA-1088 or electronically at http://www.fda.gov/medwatch/report.htm1.



Q: Where can people find more information regarding lipodissolve products?

A: For more information, please see the following websites:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm207624.htm

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm207453.htm