FDA warns of counterfeit Botox: Raleigh providers explain how to avoid dangerous products

RALEIGH, N.C. (WNCN) – The Food and Drug Administration is sending out a warning about fake Botox.

The alert comes after reported illnesses across nine states. Although North Carolina isn’t one of them, the Centers for Disease Control and Prevention is warning everyone to avoid unlicensed providers.

At Blue Ridge Dermatology, Botox is kept inside a locked refrigerator. The neurotoxin is used cosmetically to paralyze facial muscles and reduce wrinkles, but the FDA is warning of counterfeit Botox in boxes and vials that look, at first glance, very similar to the FDA-approved product.

Dr. Shelley Cathcart of Blue Ridge Dermatology in Raleigh says when used properly, Botox and other neurotoxins are generally very safe, but the products are made from the same substance that causes the potentially deadly illness botulism.

“The danger is that if you get a lot of that toxin, it can paralyze muscles you did not mean to have paralyzed, so in larger quantities, botulism is where you actually get paralysis of your diaphragm or the muscles you need to breathe,” she explained. “If somebody’s messing with this, trying to recreate this, it would be really dangerous.”

According to the CDC, 19 people in nine states have gotten sick after getting the injections and 9 of them ended up in the hospital. The FDA says it appears the counterfeit products were bought from unlicensed sellers, and some providers were not licensed or not in a medical setting.

“You should know who’s injecting you and who their medical director is and who their supervising physician is,” noted Amanda Dunning, a nurse practitioner and the owner of Glo De Vie Med Spa in Raleigh

She says only medical professionals are allowed to purchase or administer neurotoxins in North Carolina.

“You need to have a physician who purchases it from a pharmaceutical company,” she said. “They have to be a reputable pharmaceutical company. Then, who can provide, is a nurse practitioner. They can prescribe it and provide it, as well as an RN.”

Dunning says it’s important to find an established and reputable facility.

“You need people that know what they’re doing,” she explained. “Not a fly-by-night circumstance where they’re sweeping in, sweeping out, taking your money and hurting you.”

“If you’re going to a licensed medical professional who is following standard of care, which means ordering from a licensed provider of these things, they know what they’re doing,” added Cathcart. “If you’re going to somewhere reputable, you’re not going to have this issue.”

According to the FDA, there are several ways to recognize the counterfeit product:

  • The outer carton and vial contain lot number C3709C3

  • The outer carton displays the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA”

  • The outer carton and vial indicate 150-unit doses, which is not a unit made by AbbVie or Allergan

  • The outer carton contains language that is not English

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