FDA Warns of Illegal Cancer Drug Use

The FDA points out the risk factors associated with using unapproved cancer injectables and issues new warnings to health care providers.

The FDA has released a letter warning of counterfeit cancer drugs, mostly injectables. In reaction to recent shortages due to production and plant issues, the FDA drafted a formal letter warning health care providers to be wary of any injectable drugs not approved by the FDA.

“Health care providers should be aware that purchasing medications from direct-to-clinic promotions that are from non-verified sources might increase the risk of receiving a potentially unsafe and ineffective product, since the products offered for sale may be unapproved, not manufactured with the quality attributes of FDA-approved products, or counterfeit,” according to the FDA statement.

Examples of products still on the market include the unapproved versions of FDA-approved medications such as Faslodex (fulvestrant), Neupogen (filgrastim), Rituxan (rituximab) and Herceptin (trastuzumab).

FDA officials maintain that the use of these unauthorized products may put the patient more at risk because the products are of “uncertain purity, storage, handling, identity, and sourcing.” The shortages have caused hospitals and clinics in dire need of treatment options to use less effective medicines and alternative options to the drugs that are on the shortage list. In lieu of unapproved medications, the FDA claims that a number of FDA-approved versions of the unapproved medications that have been purchased through direct-to-clinic solicitations are not currently in short supply.

The FDA has also taken steps to secure other forms of the medication internationally, allowing “temporary importation of the foreign version of that medication through a controlled distribution network until the U.S. shortage of the medication is resolved,” according to the statement.

The agency has released tips for health care providers about how to help ensure the safety of their patients by pointing out the risks of purchasing unapproved injectable cancer medications. The FDA maintained that when considering treatment options, providers should:

1. Obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the United States. Determine if the wholesale distributor is licensed in the state(s) where it is conducting business.

2. Determine if the medication is FDA-approved by checking the Orange Book or Drugs@FDA.

3. Question when 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. Providers should be alert for these signs that the product is not FDA-approved:

• Packaging looks different
• Labeling is not in English
• Dosing recommendations are unfamiliar
• Dosage form or route of administration is different (eg, ampoule instead of pre-filled syringe)

5. If you receive multiple complaints about the same product, such as a new side effect or lack of therapeutic effect, these may signal a product quality issue.

6. Report product quality issues and adverse events to FDA using the MedWatch system.

7. Report suspicious activity regarding marketing and distribution of unapproved injectable cancer medications to FDA's Office of Criminal Investigation under “Report Suspected Criminal Activity.”