FDA Cracks Down Sales of Phony Botox

The U.S. Food and Drug Administration has issued warnings to purchasing agents, quality-control administrators and consumers about the purchase of counterfeit Botox by 350 U.S. medical practices.

Search for Low Prices Leads Doctors to Foreign Drug Suppliers

The U.S. Food and Drug Administration has written more than 350 medical practices about the possible dangers of using counterfeit Botox toxic for cosmetic treatments and other medical procedures. Complex supply chains, global marketing, searching for lower prices could persuade medical practices to buy drugs from foreign suppliers that fail to meet FDA standards of production, quality control, storage and transport, In particular, Botox knockoff drugs are often adulterated, counterfeit or unsafe.

FDA Issues Warning Letters

forehead Botox injectionThe warning letter, dated December 19, 2012, goes on to suggest that these medical practices need to research their suppliers more carefully to find out if they are authorized to do business in their states. Unapproved medications carry risks of infections, sickness or even death, and the Federal Food, Drug and Cosmetic Act makes importation of unapproved prescription medications illegal in all 50 states. Foreign-produced medications could have incomplete warning labels, receive improper storage or fail to meet medical standards of safety. The unapproved counterfeit Botox toxin was produced by Canada Drugs and sold in the last six months, and the wholesale Canadian drug company also uses the following names: Clinical Care, Quality Specialty Products, QP Medical, A+ Medical Supplies and Bridgewater Medical.

FDA List of Doctors Available to the Public

The FDA recommends that consumers check the list of medical practices that have received the counterfeit Botox in the last six months. Plastic surgery patients and people who use Botox for other purposes should check to see if their doctors appear on the list. The health care community has an ethical obligation to research their drug sources through increasingly complex supply chains. Drugs that foreign governments approve fail to meet U.S. standards of production, sourcing, storage, labeling and transportation.

Botox Parties and Cut-rate Pricing

Harried medical purchasing agents sometimes fail to exercise the same caution for cosmetic procedures that other medical practices routinely employ. Competition from Botox parties, self-administered cosmetic treatments and price cuts in outpatient medical procedures have created enormous pressures to find cheaper drug suppliers, but the practice could backfire. Drugs of unknown quality and origin could have incomplete directions for administering them, come from batches past their expiration dates or contain ingredients that cause allergic reactions and other side effects. Dr. Simon Ourian, Medical Director of Epione Beverly Hills, says that he’s “…created a six-point checklist that is required reading for anyone contemplating any type of Botox treatment.”

According to Dr. Ourian, “the risks of counterfeit Botox outweigh any benefits of cost savings.” The FDA urges consumers and medical practices to consider the potential consequences of using unapproved drugs. Other countries have different standards and regulations, and compounding pharmacies and clinics sometimes use cheaper ingredients to cut operational costs. The risky practice has recently caused meningitis outbreaks, botched cosmetic surgeries, muscular paralysis and severe breathing problems. The Botulinum toxin, one of the world’s most powerful poisons, offers health and cosmetic benefits when manufactured, stored and prescribed properly.