PORTLAND, Ore. (KOIN) — Marilyn Dawkins said she has Botox to thank for never having to admit she’s 67.
“I have a fake ID that says I’m 48, and I’m sticking to it,” she said.
She always trusted she was getting the real FDA-approved Botox — until KOIN 6 News showed her some documentation.
A statement issued by the FDA in November 2013 announced the agency alerted 230 medical practices over the summer – including some local practices – about distribution of “fraudulent and unapproved versions of Botox.”
The FDA sent a letter to specific doctors that said their practice may have purchased or received unapproved, fraudulent versions of Botox which “may cause harm to patients.” The letter told the doctors to stop using it if they had it.
While the FDA told KOIN 6 News the investigation is ongoing, the agency confirmed an unlicensed company — using names like “Online Botox Pharmacy,” “onlinebotox.com” and “onlinebotox” — sold something to medical practices labeled as Botox which could have “harmful ingredients” and hasn’t had the safety testing and oversight required by US law. Investigators said medications from this firm may be from foreign or unknown sources.
The FDA urged the health care community to examine its purchasing practices.
“Anybody that chooses to buy outside of the legitimate drug supply chain is going to run the risk of receiving unapproved or counterfeit medicines,” an FDA spokesperson said by phone.
Allergan, the manufacturer of authentic Botox, told KOIN 6 News doctors should purchase Botox directly from the company or its authorized distributors.
The FDA said the unlicensed supplier sent out mass faxes to clinics selling products at “prices below those of FDA-approved products.”
Dr. Roger Dailey, with the Casey Eye Institute’s Aesthetic Facial Surgery Center at OHSU, helped start the Physicians Coalition of Injectable Safety seven years ago, in part to raise awareness and prevent this type of situation.
“I know for sure that some providers in some spas are giving what they believe to be the actual product,” Dailey told KOIN 6 News. “I think the people who buy it, it’s hard for me to imagine that they don’t know that it’s not FDA-approved.”
Using a list from the FDA’s website, KOIN 6 News checked with some of the medical practices in Oregon that received the FDA’s warning letter about possible fraudulent Botox.
On the list were Aestheticare and Laser Wellness Center, 1246 NE 7th Street in Grants Pass, Bridgeport Laser and Wellness Center, 7180 SW Hazelfern Road in Tigard and the Oregon Headache Clinic, 15259 SE 82nd Drive in Clackamas.
Spokespeople for each location told KOIN 6 News they only get their Botox from Allergan, the manufacturer, but declined to answer questions on-camera. They all said they were not concerned about the products they were using on their patients.
In a statement, Bridgeport Laser and Wellness Center said, “We were contacted by the FDA in July 2013 after our name and number were found in another physician’s office. In speaking directly with the FDA, we discovered that the company “Online Botox” had used our practice name in reference as a way to help sell its products based on our large number of online 5-star reviews. We have never done business with “Online Botox” and only use Allergan products.”
The FDA would only say to KOIN 6 News that it sent letters to certain medical practices “based on information indicating that the facility purchased or received product from the supplier identified in the letter.”
If doctors are found to have used fraudulent Botox there can be serious consequences.
“If you administer a non-FDA approved medication to a patient, the medical board can take away your license,” Dr. Dailey said, “and it’s a federal offense punishable by prison time.”
The FDA told KOIN 6 News the agency notified the Oregon Medical Board about the letters it sent to physicians.
The OMB declined a request for an on-camera interview. In a written statement, Operations and Policy Analyst Nicole Krishnaswami said the board’s investigations department “contacts the physician to determine what steps are necessary.”
The investigations are confidential and what steps might be taken were not divulged. But if disciplinary action is taken, “the board’s action becomes public record.”
At this point, no disciplinary action has been taken.
On its website, Allergan clearly states how anyone can verify they are receiving authentic Botox:
“You’ll see a US license number listed beneath the copyright information. … Look for a holographic film on the vial label. Allergan should appear within the rainbow lines. If you do not see the rainbow lines or the name Allergan does not appear, do not use the product.”
Anyone who thinks they may have received fraudulent Botox — either it didn’t work right or led to a bad reaction — is asked to report that to the FDA.
Now that Marilyn Dawkins knows, she said it is “something to be aware of and now check.”
She’s only had good experiences with Botox and wants to keep it that way.
“This is my face, you know.”