FDA Issues Notification Regarding Risks of Purchasing Unapproved Injectable Cancer Medications from Unlicensed Sources

January 18, 2012 6:50 PM

Food and Drug Administration (FDA) is reminding health care providers to obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the US. FDA explains that “current shortages of injectable cancer medications may present an opportunity for unscrupulous individuals to introduce non-FDA approved products into the drug supply, which could result in serious harm to patients.” FDA reports that the agency is aware of promotions and sales of unapproved injectable cancer medications directly to clinics in the US and that the medications were likely administered to patients. Examples of products include unapproved versions of FDA-approved medications such as Faslodex® (fulvestrant), Neupogen® (filgrastim), Rituxan® (rituximab), and Herceptin® (trastuzumab). FDA stresses the risks to patients when such unapproved medications are used. The agency outlines several steps health care providers should take to ensure patient safety:

1. Obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the US. FDA provides a Web page that lists for each state the online resource for verifying that a wholesale distributor is appropriately licensed.
2. Determine if the medication you have received is FDA approved by checking the Orange Book or Drugs@FDA.
3. Question whether a price sounds too good to be true. Deep discounts may be offered because the product is stolen, counterfeit, or unapproved.
4. Carefully inspect the product and packaging and be alert for signs that the product is not FDA approved, such as if the packaging looks different or the dosing recommendations are unfamiliar.

FDA also notes that if a health care provider receives multiple complaints about the same product, such as a new side effect or lack of therapeutic effect, these may signal a product quality issue.

FDA reminds health care providers that in certain circumstances, the agency may authorize limited importation of medications that are in short supply. Such medications are imported from approved international sources and distributed in the US through a controlled network, and would not be sold in direct-to-clinic solicitations. If FDA has arranged for limited importation of the foreign version of a medication, information on obtaining that medication will be available in the Drug Shortages section of the FDA Web site.

Additional details are available in an FDA Drug Safety communication (PDF).