Archive for Thursday, April 26, 2007

Kansas to regulate LipoDissolve

April 26, 2007


Kansas has become the first state to regulate - at least temporarily - the drugs used in a fat reduction procedure called LipoDissolve.

The Kansas Board of Healing Arts on Tuesday passed a temporary regulation that will change the way physicians administer a mixture of two drugs for the procedure, which isn't approved by the Food and Drug Administration.

LipoDissolve involves a series of injections of a mixture of phosphatidylcholine and sodium deoxycholate that breaks down fat cell walls and dissolves fat to a liquid that is expelled from the body.

Mark Stafford, general counsel for the Board of Healing Arts, told The Topeka Capital-Journal, that he believes a physician may order a drug that is not approved in limited situations.

"Today, this product has been available in a way that has skirted FDA regulation and the approval process," Stafford said. "Our goal is to bring the practice back into the whole system of making sure products that are injected are safe and effective."

The regulation, which goes into effect for 120 days from Tuesday, says that physicians, surgeons or osteopaths cannot inject the drug combination until they perform a physical examination on patients and record patients' medical history. It also requires the doctors to write a prescription for a pharmacist to create the compound.

"Our understanding is that there are pharmacists out there in the world who are manufacturing this product for just general sale to physicians and businesses who want to administer it," Stafford said. "It is not compounded for a specific patient."

He said it is easy to conclude that the practice is illegal and businesses should be closed and physicians should be subject to disciplinary action for delivering the drug the way it is currently being done.

But before that happens, the board wants to give the information to practitioners and hopes for voluntary compliance.

Stafford said several medical spas in the Kansas City area and Wichita offer LipoDissolve and some, including people who aren't physicians, are buying it in bulk.

Stafford said he knows of no specific situation where someone has been hurt by LipoDissolve but the public deserves protection if there are rumors about a drug that has not been approved.


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