Federal regulators have warned more than 350 medical practices that Botox they may have received from a Canadian supplier could be unapproved, counterfeit, or unsafe. FDA Warns About Counterfeit Botox from Canadian Suppliers.
The Food and Drug Administration (FDA) sent a letter last month, which was made public last week, stating that batches of the wrinkle treatment shipped by suppliers owned by Canada Drugs have not been approved by the FDA. As a result, the agency cannot assure the effectiveness or safety of these Botox treatments. Canada Drugs has been previously tied to the distribution of unapproved and counterfeit cancer drugs.
FDA Warning About Counterfeit Botox
This warning from the FDA marks the fifth alert issued this year about foreign suppliers providing unapproved drugs. Additionally, the FDA stressed the importance of obtaining Botox and other injectables from licensed U.S. pharmacies. Otherwise, purchasing from unapproved sources puts patients at serious risk.
In the past, the FDA has issued similar warnings. For example, in February, they alerted 19 medical practices about counterfeit Avastin, a cancer treatment. Moreover, the agency has issued multiple warnings about counterfeit Avastin and Altuzan, a similar cancer drug. These counterfeit drugs, often distributed by Canada Drugs, present significant health concerns for professionals and patients alike.
The Risks of Counterfeit Botox and Other Injectable Treatments
Counterfeit Botox and other drugs distributed by Canada Drugs can pose serious and life-threatening health risks. Since injectable treatments like Botox are distributed through medical practices, authenticity becomes even more important. Therefore, doctors must ensure the safety and legitimacy of the treatments they administer to patients.
Why the Concern?
The FDA has linked ongoing drug shortages with increased financial incentives for pharmacies to sell counterfeit drugs. While genuine Botox is distributed by Allergan, counterfeit versions often come from dangerous, unregulated sources. Unfortunately, these sources are not subject to quality control and can produce unsafe, ineffective treatments.
In October, the FDA ordered about 4,100 websites to stop selling unapproved medications to U.S. consumers. Notably, the majority of these websites were operated by Canada Drugs.
Despite enforcement efforts, some of these sites were still operating as of Friday.
What You Need to Know
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Genuine Botox is made by Allergan Inc., a trusted and regulated company.
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The FDA has warned about the increasing risks of counterfeit Botox, making it essential for medical practices to ensure they only use FDA-approved and genuine Botox.
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Patients should always ask their medical providers where their Botox treatments are sourced from and ensure they’re receiving FDA-approved Botox for safety.
