Processing Magazine

FDA warns of counterfeit botox

May 7, 2013
botox
The counterfeit product is sold in a package identical to that made for the U.S. market, making it appear to be the same drug.

The U.S. Food and Drug Administration (FDA) has warned in recent days that fraudulent versions of Allergan's drug Botox are being distributed on the U.S. market. In an official statement, the FDA said that the fraudulent drug is not approved by the agency and called on healthcare practitioners and the general public to exercise caution when dealing with the drug.

The counterfeit product is sold in a package identical to that made for the U.S. market, making it appear to be the same drug. However, the vial inside is labeled as a foreign version of Botox, which is not allowed for sale in the United States. The product is being distributed by unlicensed firms and, because of that, the FDA cannot be certain that it is compliant with U.S. standards regarding manufacturing, storage and handling of medical products. The agency therefore recommends that the products are not used, as they are considered unsafe.

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The counterfeit versions of Botox are sold by a company that goes by the names "Online Botox Pharmacy," "Onlinebotox.com," and "Onlinebotox." By the time the public alert was issued, the products did not appear to be available online. However, the FDA was presented with evidence that the fake Botox was sold through "blast faxes", usually selling the product at lower prices than the officially approved version. Online Botox Pharmacy uses a U.S. return address when sending packages to medical practices, despite the fact that the products are from foreign sources -- a practice which is common for fraudulent product sales, the FDA commented.

According to licensed manufacturer Allergan, Botox is a purified version of the same toxin that causes botulism and can cause potentially deadly swallowing and breathing difficulties if used wrongly. Last year the product generated sales of $1.77 billion, with about half of this coming from cosmetic use, Reuters reported.

The FDA warned that medical products manufactured abroad and not having any state or federal approval may be "misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe." It also noted that medical practices that buy and use illegal or unapproved medical products from foreign sources may be compromising patients' health and safety, as they may not be receiving adequate treatment.

The Botox for injection which the FDA has approved for the U.S. market is manufactured by Allergan and displays the active ingredient as "OnabotulinumtoxinA" on both the outer carton and vial. At present, there is no indication that Allergan's FDA-approved version is at risk, so it can still be considered safe and effective for its intended and approved uses, the FDA statement explained. Medical practices can identify the counterfeit version by two main features: the outer carton shows the active ingredient as "Botulinum Toxin Type A" and the lot number and expiration dates on the outer carton and the vial inside do not match. The public is asked to report suspect Botox products obtained from Online Botox Pharmacy or other questionable sources to the FDA immediately.The U.S. Food and Drug Administration (FDA) has warned in recent days that fraudulent versions of Allergan's drug Botox are being distributed on the U.S. market. In an official statement, the FDA said that the fraudulent drug is not approved by the agency and called on healthcare practitioners and the general public to exercise caution when dealing with the drug.

The counterfeit product is sold in a package identical to that made for the U.S. market, making it appear to be the same drug. However, the vial inside is labeled as a foreign version of Botox, which is not allowed for sale in the United States. The product is being distributed by unlicensed firms and, because of that, the FDA cannot be certain that it is compliant with U.S. standards regarding manufacturing, storage and handling of medical products. The agency therefore recommends that the products are not used, as they are considered unsafe.

The counterfeit versions of Botox are sold by a company that goes by the names "Online Botox Pharmacy," "Onlinebotox.com," and "Onlinebotox." By the time the public alert was issued, the products did not appear to be available online. However, the FDA was presented with evidence that the fake Botox was sold through "blast faxes", usually selling the product at lower prices than the officially approved version. Online Botox Pharmacy uses a U.S. return address when sending packages to medical practices, despite the fact that the products are from foreign sources -- a practice which is common for fraudulent product sales, the FDA commented.

According to licensed manufacturer Allergan, Botox is a purified version of the same toxin that causes botulism and can cause potentially deadly swallowing and breathing difficulties if used wrongly. Last year the product generated sales of $1.77 billion, with about half of this coming from cosmetic use, Reuters reported.

The FDA warned that medical products manufactured abroad and not having any state or federal approval may be "misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe." It also noted that medical practices that buy and use illegal or unapproved medical products from foreign sources may be compromising patients' health and safety, as they may not be receiving adequate treatment.

The Botox for injection which the FDA has approved for the U.S. market is manufactured by Allergan and displays the active ingredient as "OnabotulinumtoxinA" on both the outer carton and vial. At present, there is no indication that Allergan's FDA-approved version is at risk, so it can still be considered safe and effective for its intended and approved uses, the FDA statement explained. Medical practices can identify the counterfeit version by two main features: the outer carton shows the active ingredient as "Botulinum Toxin Type A" and the lot number and expiration dates on the outer carton and the vial inside do not match. The public is asked to report suspect Botox products obtained from Online Botox Pharmacy or other questionable sources to the FDA immediately.