FDA Concerned Not All Patients Being Treated With Approved Botox

More than 350 medical practices across the country recently got warning letters from the FDA about where they were buying their Botox . Some local physicians are on the list provided by the FDA.

By Diana Gonzalez
|  Friday, Feb 15, 2013  |  Updated 10:13 PM EDT
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More than 350 medical practices across the country recently got warning letters  from the FDA about where they were buying their Botox. Some local physicians are on the list provided by the FDA. Diana Gonzalez reports.

More than 350 medical practices across the country recently got warning letters from the FDA about where they were buying their Botox. Some local physicians are on the list provided by the FDA. Diana Gonzalez reports.

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It's injectables week at Miami Plastic Surgery, and Mary Cowart is taking advantage of the discounted prices to relax some of the lines on her face.

Before she started getting Botox injections there she researched plastic surgeon Dr. Michael Kelly.

"Also read up on the Botox, and he's also explained where they obtained the products. So I've always felt safe. I've never had any doubt or question that I was getting the real thing, " Cowart said.

While Kelly says he uses only FDA approved Botox cosmetic, that's not necessarily the case in other practices.

More than 350 medical practices across the country recently got warning letters from the FDA about where they were buying their Botox . Some local physicians are on the list provided by the FDA.

Among these doctors is Coral Gables dermatologist Maria Elena Kendall and Dr. Constantino Mendieta, known as the surgeon who developed the Miami thong lift.

Each letter warns that the "medical practice has received medications from foreign or unlicensed suppliers owned and operated by Canada drugs ... Including versions of Botox…"

It goes on to say: "FDA is very concerned that products distributed by these suppliers may cause harm to patients, because they may be unsafe or ineffective."

Kelly said the range of possible risks include infectious problems if the medications weren’t handled in a sterile manner, and “ concentration problems where you're getting a much bigger dose of Botox than what you should be getting, and that was the problem with the people up north who had the paralysis."

That was the case in 2004 in Fort Lauderdale, where 4 people were treated with unapproved botulinim toxin and were temporarily paralyzed and near death.

The office staff at Miami Plastic Surgery says they are frequently solicited by questionable suppliers.

"They say ‘Oh you know they have cheaper prices for botox and some of the other injectables that we use,’" said Maria Andrew.

Kendall declined to give NBC 6 an interview or a written statement.

Mendieta said he was unable to do an interview with NBC 6 due to his busy surgical schedule. In an email response, he stated another doctor suggested his practice buy botox from Canada.

"We felt this would benefit our patients by lowering their cost without compromising their safety since botox is only made by Allergan and only manufactured in Ireland. We were not clear that this particular practice is frowned upon by the state,” Mendieta said in his email.

Kelly says when patients come in for injections they can check the vial. It should say Botox Cosmetic not just Botox . There's also a vertical hologram across the label that says Allergan .

"I don’t think there’s anything wrong with a patient looking and saying doctor did this drug come from the united states did you buy it from the United States,” Kelly said.

FDA: Letters to doctors about risks of purchasing unapproved versions of Botox and other medications from foreign or unlicensed suppliers.

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