ASPS reinforces patient safety measures in the wake of reports of counterfeit Botox injections

With 22 women from 11 states reporting harmful reactions after receiving what authorities believe to be counterfeit Botox, ASPS is reinforcing the critical importance of protecting patients and practicing medicine responsibly – in clinical settings and within the physician's scope of training.

According to the Centers for Disease Control, reported cases include "injections administered by unlicensed or untrained individuals in non-healthcare settings, such as homes or spas."

"Patient safety is paramount and incidents like these require patients to have heightened vigilance," says ASPS President Steven Williams, MD. "We urge patients to exercise caution."

"Do your homework," adds The PSF President Scot Glasberg, MD. "Although Botox seems like a very easy procedure, clearly, as demonstrated, there are risks to it. That's why you want to know who you're going to."

The symptoms, which include blurred or double vision, difficulty swallowing and muscle weakness, are similar to those seen when botulinum toxin spreads to other parts of the body, noted the FDA in an April 16 announcement. There is no indication that the reported events are linked to AbbVie's FDA-approved Botox, and the genuine product should be considered safe and effective for its intended and approved uses. Allergan Aesthetics, an AbbVie company, manufactures its Botox products in 50-, 100- and 200-unit dose forms. A statement from Allergan notes that both providers and consumers can identify authentic products via descriptions on the outer cartons, which are either "BOTOX®️ COSMETIC / onabotulinumtoxinA / for Injection" or "OnabotulinumtoxinA / BOTOX®️ / for injection." The manufacturer identified on the outer carton is either "Allergan Aesthetics / An AbbVie Company" or "abbvie." FDA-approved Botox displays the active ingredient as "OnabotulinumtoxinA" on the outer carton and vial – along with the hologram of the word "Allergan" on the vial label. The company adds that patient requests to see the labels might increase as a result of this information.

In the statement, Allergan said it has a comprehensive supply chain security program to ensure its products are safe, secure and sold through authorized distribution channels.

"All reports of counterfeit product are thoroughly investigated by our team and in conjunction with law enforcement and public health authorities where appropriate," says Adelle Infante, associate vice president of Global Communications for Allergan Aesthetics.

How to spot counterfeit Botox

The counterfeit product, meanwhile, includes telltale information that can be found on the outer carton and vial. The counterfeit product may be identified by one or more of the following:

• 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 the manufacturer
• The outer carton contains language that is not English

ASPS is also alerting patients of the following tips for spotting counterfeit injectables and avoiding complications:

• Counterfeit products are often quoted at a significantly lower price. Prices from clinic to clinic can vary, but if a price seems too good to be true, it should raise concerns.
• The Society emphasizes the importance of receiving Botox and other injectables exclusively from licensed professionals who adhere to strict safety standards in clinical settings.
• Patients can best protect themselves and significantly reduce the risks associated with cosmetic procedures by consulting a board-certified plastic surgeon who is a member of ASPS. Plastic surgery as a specialty requires extensive training, experience and expertise to perform procedures safely and effectively.

"If a provider is hesitant to share details about their training, credentials or where they purchased the product, that behavior should be a massive red flag – and patients should not be afraid to ask questions or reconsider if they are at the right place to receive a treatment," Dr. Williams says.

The Society also reminds patients that injections should always be administered in a clinical setting that provides a clean, controlled environment that follows strict sterilization standards and has the necessary safety equipment to address any possible complications.

"Patients should be suspicious if they are offered Botox injections in hotel rooms or at home," Dr. Williams says. "Plastic surgeons are not just expert injectors of these types of medications but are well prepared to manage potential complications."

The FDA advises consumers to report suspected counterfeit Botox products to the FDA at (800) 551-3989 or through www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm.