As a patient, you trust that the medication and treatments you receive are authentic and safe. Doctors and medical professionals also work under the belief that the products they provide their patients meet a strict level of standards, including drugs used during surgical procedures. Unfortunately, there will always be those who attempt to make money unethically, with little regard for the consequences of their actions. With the FDA's recent discovery of sales of fraudulent versions of Botox, a familiar scenario is being played out.
Nearly ten years ago, four patients were hospitalized after receiving injections of what they were told was Botox, a sterile, purified version of the toxin that causes botulism and when injected, can temporarily smooth certain wrinkles. Instead they were given an unapproved botulinum toxin. Initially, these patients may have suspected their complications were from surgical mistakes. However, the results of a wide-scale investigation of U.S. medical clinics found that dozens of people were treating patients with unsafe substitutes for Botox which lead to surgical complications.
As recently as 2012, the FDA warned over 350 medical facilities that they might have received unapproved medications from a foreign supplier. Now the FDA has discovered that counterfeit versions of Botox, manufactured for sale in the U.S. by Allergan Inc. are making their way into medical offices. The agency warns that the outer carton is counterfeit, and the vial contained inside is a foreign version of Botox, which is not FDA-approved for sale in the U.S. The FDA says they "cannot confirm that the manufacture, quality, storage, and handling of these products follow U.S. standards," adding that fraudulent versions should be considered unsafe and not used.
In this case, the FDA says, the fake Botox was not being sold on the Internet, but through faxes sent to medical offices offering lower prices than Botox is usually sold for. Any products or sellers with the names "Online Botox Pharmacy," "OnlineBotox.com," or "Onlinebotox" should be considered fraudulent.
This FDA alert comes at a time when lawmakers are working to keep the public safe from counterfeit or contaminated products. Both the House of Representatives and the Senate recently released drafts of bills intended to create a national set of standards for tracking prescription drugs through the distribution chain. While the House bill would require drugs to be traced by lots, which could contain many individual packages, the Senate draft calls for each individual drug unit to be traceable. The best outcome would be legislation that protects patients from medical complications due to unsafe products.
Reuters, Fraudulent Versions of Allergan's Botox Found in U.S., 4-26-13
FDA, Fraudulent Versions of Botox Found in the United States, 4-26-13