Because neither ingredient was approved by the FDA for fat elimination and the combination was not approved for anything in the U.S., use of Lipodissolve was a "double concern," said Dr. Malcolm Roth, director of plastic surgery at Maimondes Medical Center in Brooklyn, N.Y., and president-elect of the American Society of Plastic Surgeons.
"Infection, gangrene of the skin, scarring ,chronic pain and deformity are some of the adverse effects seen," said Roth.
"Some also experienced hard lumps where the fat cells had died and clumped together," added Antell.
Ultimately the FDA issued warnings to the public not to use Lipodissolve, and the combination was banned in Canada and Brazil.
It wasn't the combination that was dissolving fat however, noted Dr. Carolyn Jacob, director of Chicago Cosmetic Surgery and Dermatology, it was the DC alone.
Thus, with the trials of ATX-101, Bayer and KYTHERA are testing the safety and efficacy of using a DC solution, sodium deoxycholate, from controlled sources in hopes of producing an injectable that can get regulatory approval in the United States and abroad.
How would deoxycholate work?
Deoxycholate is a common ingredient in soap, that "you'd probably find in your laundry detergents," said Antell. "What soaps do in your laundry detergent is ... help dissipate fatty tissue so that you can get grease and oil stains out of your clothing."
The breakdown of fatty tissue is purportedly the same thing that's happening in the body when DC is injected subcutaneously.
"But you have to wonder: Where does that dissolved material go?" asked Antell.
Roth echoed the concerns, questioning whether small bits of fatty tissue could do damage to the liver, clog the arteries or potentially cause a stroke if they make their way to the brain through the blood stream.
Because there are existing means of breaking down fat using cooling that have not shown signs of adverse effect, Jacob said, "I'm less concerned about what happens to the dissolved fat as what happens when the medication seeps into the surrounding areas, possibly causing breakdown of the skin or other tissues."
This becomes a greater concern if DC is injected into large areas such as the abdomen and buttocks, despite the fact that it only currently is being tested for use in the small under-chin area.
Jacob, Antell and Roth said that if ATX-101 gets approved for ameliorating double chins, it undoubtedly would be used off-label for other larger, untested areas of the body.
"Any time there is an injection [for fat loss], there will be tremendous temptation for people to abuse it and possibly inject themselves," Antell said. "We all like minimally invasive surgeries, but it's still wait and see at this point [for ATX-101]. I would be very cautious."