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FDA Warns US Practices Against Using Unapproved Foreign Botox

Samson, Kurt

doi: 10.1097/01.NT.0000427575.49179.46

The US Food and Drug Administration has advised medical practitioners who purchased botulinum toxin type A from a Canadian supplier that the drug has not been approved for use in the United States and may be ineffective or harmful to patients.

In a Dec. 19 statement, the agency said that it had alerted 350 medical practices, by letter, that had purchased unapproved botulinum toxin (onabotulinumtoxinA, or Botox) from Canada Drugs (, located in Winnipeg, Manitoba, and several affiliated companies that it supplies, including Quality Specialty Products, A+ Health Supplies, QP Medical, Bridgewater Medical, and Clinical Care.

Although most notified physicians were dermatologists and cosmetologists, several were neurologists and pain management providers. The agency requested that physicians stop using the drugs and retain and secure all remaining products.

“These medications may be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe,” according to the FDA. Physicians purchasing and administering illegal and unapproved medications from foreign sources “are placing patients at risk and potentially depriving them of proper treatment,” the agency warned.

While no health problems associated with product use have been reported, the agency said that it is concerned that the drugs may lack proper labeling, boxed warnings, or the required patient Medication Guide to ensure correct use.

“FDA urges the health care community to examine its purchasing practices to make sure that products are purchased directly from the manufacturer or from state-licensed wholesale drug distributors in the United States,” the statement said.

“The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering them.”

Botox is manufactured by Allergan, Inc., of Irvine, CA, and has been approved for treating upper limb spasticity, cervical dystonia, upper motor neuron syndrome, migraine, and urinary incontinence due to multiple sclerosis and spinal injury.

The FDA has published the names of the individual practices that were sent letters on its website, together with contact information for reporting activity related to unapproved drug purchases and a state-by-state list of wholesale distributors providing approved products. The information is available at the following:

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Francis O. Walker, MD, professor of neurology and neuromuscular conditions, and director of the Movement Disorder Clinic at Wake Forest University School of Medicine in Winston-Salem, NC, told Neurology Today in a telephone interview that only a handful of neurologists were sent letters.

“Most of them are dermatologists. I don't know anyone in neurology who would do this, or understand how they could.”

It is impossible to know how widespread the practice is, but part of the problem is a lack of adequate oversight of those individuals at medical practices charged with acquiring medications, he said.

“These people are under tremendous financial pressure. They are required to obtain drugs yet cut costs, which is unreasonable, so there needs to be more aggressive monitoring.”

He emphasized that while botulinum is one on the most neurotoxic agents known, even when diluted, its widespread use in cosmetic dermatology has resulted in a general sense that the drug is safer than it really is, even with evidence to the contrary.

In a 2008 investigation, Public Citizen found a total of 16 deaths in patients, including four children, after injected botulinum spread to other parts of the body, causing paralysis and other symptoms. Severe allergic reactions have also been reported.

“Botulinum is unbelievably toxic, and I cannot understand how many doctors are so cavalier about purchasing it, let alone [other] unapproved products. This whole business is just scary,” Dr. Walker said.

©2013 American Academy of Neurology