FDA Drug Safety Podcast: Investigation into New England Compounding Center

 

[11-13-2012] This is a FDA Drug Safety Alert from the Division of Drug Information on the investigation into New England Compounding Center, or NECC, and the multistate outbreak of fungal meningitis and other infections.

FDA is concerned about the lack of sterility in products produced at the NECC Framingham, Massachusetts facility. As a result of FDA, CDC, and state health departments' ongoing investigation of contamination at the facility, NECC announced a recall of all its products and has voluntarily shut down.

FDA and CDC identified the fungus Exserholium rostratum in NECC- supplied, preservative-free methylprednisolone acetate products. These products from 3 implicated lots may have been given to 14,000 patients.  Bacteria have also been identified in NECC- supplied preservative-free injectable betamethasone and cardioplegia solution, but the clinical significance of the bacteria identified is not known. Fungal cultures for these two products are pending.

Healthcare professionals should retain and secure all remaining products purchased from NECC, and contact the facility at 1-800-994-6322 to obtain instructions on how to return products to NECC.

FDA also advises healthcare professionals to follow-up with patients who have been administered an injectable product shipped by NECC on or after May 21, 2012, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, or a cardioplegic solution.  You should inform these patients of the symptoms of possible infection and instruct them to contact you immediately if they experience symptoms.

FDA does not urge patient follow-up at this time for NECC products of lower risk such as topicals and suppositories, or for patients who received an NECC product in these categories before May 21, 2012 unless they’ve reported symptoms of infection.

We ask you to use your clinical judgment in deciding which patients are at risk and need to be contacted. FDA has posted a patient notification letter on our webpage at www.fda.gov for healthcare providers to personalize and send to their patients.  Also posted on our webpage are lists of customers who received products from NECC.

Please report any suspected adverse events following use of these products to FDA's MedWatch program at 1-800-332-1088 or online at www.fda.gov/medwatch.

You may also reach FDA’s Drug Information Line at 1-855-543-DRUG and press * to get the most recent information regarding the multistate outbreak. Again that is 1-855-543-DRUG, then press *.

We take our responsibility to safeguard the nation’s medical drug supply very seriously, and we are committed to doing everything we can to help ensure this situation does not happen again. 

FDA is continuing its investigation and will update the public of all changes.