Michael Gold, M.D., at the MauiDerm 2014 conference shared his insight into the world of fake botulinum toxins. There is a huge counterfeit market, he said. It behooves dermatologists to be aware, because the phony products are easily acquired over the Internet or purchased overseas and carried into the United States. These fake products look exactly like their legitimate counterparts, and the consequences of acquiring and using such products can be highly detrimental to patients — not to mention, it’s illegal to use fake products.
While the United States does not have the most incidents of pharmaceutical crime, it ranks high, according to a new Pharmaceutical Security Institute that is studying the threat of counterfeit products and how to control the problem.
- Risks clinicians can take with fake products include:
- Contamination — products could carry unknown, harmful pathogens;
- Unknown origination — products are untraceable to any manufacturer;
- Uncontrolled — there is no quality assurance;
- Fluctuant potency — products are not standardized, which could lead to unwanted side effects and death;
- It’s illegal.
There is a legitimate Chinese toxin called ChinaTox (Lanzhou Biologic Products Institute). The product has several different names and is available in several parts of the world, including:
- Prosigne — Brazil
- Redux — Peru
- Lantox — Russia, Columbia
- Lanzox — Indonesia
Data behind ChinaTox is somewhat concerning, according to Dr. Gold, medical director and founder of Gold Skin Care Center, Advanced Aesthetics Medi-Spa, Tenessee clinical research Center, The Laser and Rejuvenation Center, Nashville, Tenn.
In an open label study in which ChinaTox was compared with Botox (onabotulinumtoxinA, Allergan), a total of 785 patients with facial spasm and dystonia were treated. Among them, 192 patients received Botox and 593 received ChinaTox. Results showed that higher doses of ChinaTox were required to achieve the same results as those achieved with Botox, and five patients receiving ChinaTox developed rashes.
Additionally, there is a Russian product called Relatox. A citation exists on a study that analyzes this product compared with Botox, indicating comparable safety, dosing and toxicity results for the correction of mimic wrinkles; however, the actual study has not been found.
Potency studies with acquired fake products have had variable results, ranging from mouse mortality to no effect. The products appear to originate in China and Canada.
Labeling of fake products is very similar to legitimate products; however, there are signs clinicians can look for to spot a phony, such as expiration dates and misspellings.
The Food and Drug Administration is cracking down and investigating the use of unapproved botulinum toxins. In 2013, a warning was sent to a number of doctors noting they may have received unapproved products. In reviewing the FDA criminal investigations, however, there are many dermatologists.
“We’re seeing more and more case studies of unapproved product being injected and the resulting side effects,” Dr. Gold said.