Dallas Area Hospital Among Hundreds Receiving FDA Warning About Unapproved Versions of Botox

The FDA has issued warning letters to over 350 US medical practices that they may have purchased unapproved medications, including unapproved versions of Botox from wholesalers owned by foreign suppliers. The medical practices were warned that the suppliers sold drugs not approved for sale by the FDA that may be counterfeit.

In this latest incident of US doctors buying prescription medication for patients from questionable and unapproved sources, doctors in 38 states, and one hospital have received warnings that they have made purchases from an unapproved foreign supplier of medication.

In February 2012, the FDA warned doctors in 19 states that they may have purchased counterfeit versions of the cancer drug Avastin from an unapproved foreign supplier. Additional warnings were issued on April 5, April 23, June 28 and September 10, 2012.

Thus far a doctor in Missouri, another in Maryland and a third in Tennessee have been investigated for purchasing misbranded cancer medication.

The warning was issued about the unapproved Botox on December 19, 2012. The FDA states that “To minimize the chance of patients receiving an unapproved, counterfeit, unsafe, or ineffective medication, FDA requests that medical practices stop administering the unapproved versions of Botox and any other products they have received from foreign suppliers owned and operated by Canada Drugs and known under the following names: Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care. Many, if not all, of the products sold and distributed by these suppliers have not been approved by FDA.”

Said Thomas Christl, Acting Director of Drug Security, Integrity and Recalls, “FDA is very concerned that products distributed by these suppliers may cause harm to patients, because they may be unsafe or ineffective,” and requested that the 350 practices stop administering medicines purchased from any unapproved foreign source.
These products “may be from unknown sources, may have unknown ingredients, may be counterfeit, or may not have been manufactured, transported or stored under proper conditions as required by U.S. law, regulations, and standards,” he warns.

The FDA reminds the health care community to be vigilant in purchasing medications, “FDA urges the health care community to examine its purchasing practices to make sure that products are purchased directly from the manufacturer or from state-licensed wholesale drug distributors in the United States. Health care professionals, pharmacies, and wholesalers/distributors are valuable partners in efforts to protect consumers from the risks of unsafe or ineffective products that may be stolen, counterfeit, contaminated, or improperly stored and transported. The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering them.”

Christl’s letter also warns that “in virtually all cases, importing or causing the importation of unapproved prescription medications from foreign sources violates the Federal Food, Drug, and Cosmetic Act and is illegal.”

The LA Times reported that “in October, the FDA ordered operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers. The vast majority of those sites were operated by Canada Drugs.” The FDA moved to take down Canada Drugs’ various sites by contacting their domain registrar to have the sites disbanded.

According to the Wall Street Journal, Canada Drugs many websites quickly reappeared after switching to a new registrar, Rebel.com, that cultivates fake online pharmacies.

The FDA warns that “unapproved botulinum toxin products may not contain the boxed warning or Medication Guide in its labeling as required in FDA-approved products. As a result, the healthcare provider and patient may not be fully informed of the serious risk of harm or death associated with botulinum toxin products.”

A full list of all the doctors and medical practices who received warning letters can be found here.