Fat-melting drug Lipodissolve outlawed by Kansas board / LJWorld.com

Archive for Sunday, August 19, 2007

Associated Press

August 19, 2007

Topeka — The Kansas State Board of Healing Arts has outlawed the use of Lipodissolve, a controversial fat-melting injection, unless it has been authorized by a doctor as part of a drug trial.

Lipodissolve, which has not been approved by the Food and Drug Administration, is a trademark name. It's administered by injections that are not designed to treat obesity, but rather to flush out fatty deposits from various parts of the body.

"We have to protect the public from the potentially disastrous effects of unproven drugs," said Mark Stafford, the board's general counsel.

The board's unanimous action Saturday covers the most common form of Lipodissolve, consisting of phosphatidylcholine and sodium dioxycholate. The restrictions were expected to take effect in mid- to late September, Stafford said.

The board in April passed a temporary regulation that called for more physician involvement in the administration of Lipodissolve. Saturday's action went beyond that, adding the provision that the compound only be used in drug trials.

The board held a public hearing on the matter last month.

It is not clear how many Kansas businesses will be affected by the new restrictions and to what degree. Stafford said the board did not have firm numbers on Kansans who have received the injections or the number of Kansas facilities that administer Lipodissolve.

He said the board has been aware of about a dozen such facilities on the Kansas side of the Kansas City metropolitan area recently.

The board received at least a half-dozen complaints on facilities that give the injections. He said the complaints, which are under investigation, include problems involving business practices and adverse reactions to the injections, such as nodules, infections and nausea.