FOR IMMEDIATE RELEASE                                                           Contact: DOH Communications

October 18, 2012                                                                              Jessica Hammonds, (850) 245-4111

STATEMENT FROM SURGEON GENERAL AND SECRETARY OF HEALTH DR. JOHN ARMSTRONG

"The Florida Department of Health continues to reach out to all Florida facilities and practices that have received any New England Compounding Center (NECC) medications since January 2012.  With an abundance of caution and reflecting the guidance of the Food and Drug Administration, the Department of Health is contacting again all 260 Florida facilities that received any NECC medications to remind them of the following messages:

1.  Follow-up with all patients who may have received any NECC medication in your facility or practice since May 21, 2012, to alert these patients to the possibility of infection.  DOH previously contacted all 260 facilities on October 15 to convey this information.     

2. Reassure your community that your facility or practice has followed FDA recall procedures for all NECC medications. In partnership with the Florida Department of Business and Professional Regulation, professional medical societies, pharmacy associations, and the Florida Hospital Association, all health care facilities and physicians in Florida were notified of the voluntary recall on October 5, 2012.

Patient care settings in Florida are free of contaminated NECC steroid medications that have been used for back and joint pain injections. No epidural injections with the contaminated steroid were provided for labor and delivery epidural pain relief. The fungal meningitis from contaminated steroid back injections is not contagious and cannot be passed from person to person."

BACKGROUND

The FDA provided a list of 260 facilities to our state, and also shared guidance with our Department to encourage patient outreach. The FDA, in an abundance of caution, has urged health care facilities that may have received NECC medications to follow up with any patients that used NECC medications during eye surgery or open heart surgery since May 21, 2012. The notification should be at a minimum, by letter, and include information on signs and symptoms of potential infection.

On Sept. 25, the NECC, in coordination with the FDA, the Massachusetts Board of Pharmacy and Centers for Disease Control and Prevention, initially recalled three lots of methylprednisolone acetate principally used for epidural back injections. These contaminated lots have been implicated in the nationwide fungal meningitis outbreak.

The signs and symptoms of meningitis related to epidural NECC medication injections include fever, headache, stiff neck, nausea and vomiting, sensitivity to light, and altered mental status.  Symptoms for other possible infections related to NECC medications include fever; swelling, increasing pain, redness, warmth at injection site; vision changes, pain, redness or discharge from the eye; chest pain or drainage from the surgical site (infection within the chest).

The expanded recall notice on Oct. 5 included 12 injectable products from NECC. With FDA guidance, NECC voluntarily recalled all NECC medications on Oct. 6.  On Oct. 15, the FDA issued a MedWatch Alert advising health care professionals and facilities to conduct outreach to any patient who may have received any injectable NECC medications, including those used in eye or heart surgeries, since May 21, 2012.  DOH continues to collaborate with the Florida Department of Business and Professional Regulation, professional medical associations and affected clinics to ensure that NECC medications are recalled appropriately in Florida.

DOH will continue to update our website at http://newsroom.doh.state.fl.us/. We have set up a toll-free hotline at 1-866-523-7339 for those who may have additional questions. To view the FDA’s list of NECC products, please visit http://www.fda.gov/Safety/Recalls/ucm322979.htm