News

Recent FDA recommendation for voluntary recall related to AmEx Pharmacy products

UPDATE: FDA recommends voluntary recall and warns against use of AmEx Pharmacy sterile products

We updated our advice of 7/3/19 to clarify that the FDA recommended a voluntary recall (but no recall occurred) and warned against the use of AmEx Pharmacy sterile products. This update also provides more details.

 In May 2019, the FDA inspected Florida outsourcing facility, AmEx Pharmacy, and observed conditions that could cause its drugs to become contaminated or otherwise pose risks to patients. On June 25, 2019, the FDA recommended that AmEx Pharmacy voluntarily recall drugs intended to be sterile. AmEx Pharmacy did not issue the recall.

On June 28, 2019, the FDA warned patients and health care professionals not to use AmEx Pharmacy products intended to be sterile due to a lack of sterility assurance. It advised physicians to “quarantine any drugs prepared by AmEx Pharmacy, and not administer or provide them to patients” (https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-sterile-products-pacifico-national-inc-dba).

In a statement, AmEx Pharmacy points out that there have been no reports of harm, and that each batch of Avastin has been determined to be sterile (http://amexpharmacy.com/sterile-ophthalmic-injections/).

The FDA’s recommended voluntary recall and warning have occurred during a known shortage of Avastin. Those practices that have obtained Avastin from AmEx Pharmacy may have difficulty obtaining it elsewhere. However, administering a medication that the FDA has warned health care providers not to use could be difficult to defend if the patient later alleges harm. We recommend that ophthalmologists who are considering using Avastin from AmEx Pharmacy advise patients of the FDA warning before administering it. Patients might refuse to consent to the injection under these circumstances.

We feel the safest course is to follow the FDA advice. Since there are no reports of harm to patients, there is no need to notify patients who have received prior doses of Avastin prepared by AmEx Pharmacy.

If the practice has access to Avastin prepared by another outsourcing facility, it can continue to treat patients with Avastin. If the practice does not have Avastin, patients who need treatment may need to be switched to a different anti-VEGF agent or other medication. This switch will have financial implications for the patient and the practice. We recommend discussing these financial issues with the patient. We also recommend obtaining informed consent for the new medication. Our sample consent forms for other anti-VEGF medications are available at https://www.omic.com/lucentis/ or https://www.omic.com/eylea/.

OMIC policyholders are encouraged to contact our confidential Risk Management Hotline if they need further assistance. Please call 800-562-6642 option 4 or email riskmanagement@omic.com.