FDA Warns Against Unapproved Drugs From Foreign Suppliers

Megan Brooks

Disclosures

December 21, 2012

More than 350 medical practices in the United States may have received unapproved medications, including unapproved versions of Botox, from a foreign supplier, the US Food and Drug Administration (FDA) warned on its Web site this week.

"These medications may be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. Medical practices that purchase and administer illegal and unapproved medications from foreign sources are placing patients at risk and potentially depriving them of proper treatment," the agency said.

The FDA has sent a letter to the physicians or medical practices involved informing them of the situation.

A list of the doctors and clinics that received the letter is available here.

Products Not FDA Approved

To reduce the chance of patients receiving an unapproved, counterfeit, unsafe, or ineffective medication, the FDA is asking 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. Therefore, FDA cannot confirm that the manufacture and handling of these products follow U.S. regulations or that these medications are safe and effective for their intended uses," the FDA said. Medications not approved by the FDA may also lack the necessary and required labels that ensure their appropriate and safe use, the agency reminds clinicians.

So far in 2012, the FDA has issued letters to medical practices in the United States that purchased unapproved medications from foreign suppliers 5 times: on February 10, April 5, April 23, June 28, and September 10.

The FDA is asking healthcare providers to examine their purchasing practices to ensure 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," the FDA said.

Healthcare providers are asked to report suspected criminal activity to FDA's Office of Criminal Investigations (OCI) by calling 1-800-551-3989 or visiting the OCI Web site.

The FDA has provided information on its Web site on how to verify that a wholesale drug distributor is licensed in the state(s) where it is conducting business.

Adverse events related to the use of suspect medications may be reported to MedWatch, the FDA's safety information and adverse event reporting program, either online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

processing....