Breaking News: US Food and Drug Administration (FDA) has identified a third batch of counterfeit cancer medication in the United States. On February 5, 2013, the FDA posted a health practitioner warning about this latest counterfeit version of the cancer treatment Avastin.
According to the FDA “lab tests have confirmed that at least one batch of a counterfeit version of Roche’s Altuzan distributed in the United States contains no active ingredient.” The counterfeit drugs allegedly have been distributed by New York-based supplier, Medical Device King/Pharmalogical, reports the FDA warning. This is the first time a US drug supplier has been implicated in the distribution of counterfeit cancer drugs.
By making this announcement to health care providers, the FDA is adopting a new strategy. The alert emphasizes the importance that health care providers’ purchasing choices have in ensuring patient safety. In appealing to health care providers’ responsibility to patients, the FDA states:
“Medical practices that purchase and administer unapproved medicines are putting patients at risk of exposure to medicines that may be counterfeit, contaminated, or improperly stored and transported. For most of these medicines, there are FDA-approved versions readily available in the United States. FDA cannot ensure the safety and efficacy of any product that has not undergone the rigorous scientific review that is part of FDA’s approval process. To protect patient health, health care professionals should use only FDA-approved medicines.”
FDA Asks Health Care Professionals to Help Ensure the Safety
of their Patients
In the health care provider warning posted for this latest incident, the FDA has asked that health care providers minimize their patients’ exposure to counterfeit/misbranded/poorly stored by following four steps to drug safety:
1. If a medication’s price sounds too good to be true, it can be a sign the drugs offered are substandard, unapproved, stolen or counterfeit. Purchasers should be wary of deep discounts on expensive drugs.
2. Look for the following signs to verify whether or not the medication in question is FDA-approved:
- The medication name is different from the name of the product ordered.
- There are noticeable differences in the packaging from drugs that you have ordered previously.
- Any of the labeling is printed in a language other than English.
- Dosing recommendations are unfamiliar.
- The way the drug is administered has changed (e.g., ampule instead of pre-filled syringe).
- The National Drug Code (NDC) number is missing from the package.
3. Look up the medicines you have purchased in the FDA’s Orange Book or via Drugs@FDA to
verify their authenticity.
4. If your patients report issues with the medication, such as no alleviation of symptoms, odd side effects, or other problems, consider this a product quality issue and report it to the FDA via the MedWatch system.
Counterfeit cancer medication first appeared on the FDA’s radar in February 2012, when a warning was posted about counterfeit versions of Avastin, an injectable cancer treatment. The current warning comes almost one year to the day as the original counterfeit Avastin warning. Since then a second batch of counterfeit cancer treatments were found in April, six US citizens have been prosecuted for buying or distributing counterfeit cancer medications, and 134 US doctors have received warning from the FDA about their business transactions with the various foreign suppliers that supplied the fake cancer drugs.