Tallahassee, FL - October 22, 2012 -
Tallahassee Memorial Hospital Release
“We have received numerous phone calls from patients concerned about the recent outbreak of fungal meningitis reportedly caused by contaminated steroid injections. Federal officials have traced this outbreak to the pharmaceutical company New England Compounding Center and their steroid Methylprednisolone Acetate.
Tallahassee Memorial Center for Pain Management does not use this company for any of our medications, nor do we use the steroid in question. Tallahassee Memorial Center for Pain Management utilizes the steroid Triamcinolone, also known as Kenalog, and it is supplied to us by Bristol-Myers through our supplier Henry Schein.
Additional information can be found on the Center for Disease Control’s website at www.cdc.gov. Because patient safety is our highest priority, we will continue to follow this important issue; however, rest assured you have not been exposed to the contaminated steroid as a patient of Tallahassee Memorial Center for Pain Management.”
Tallahassee, FL - October 22, 2012 - The Florida Department of Health (DOH) and the Florida Department of Business and Professional Regulation (DBPR) today contacted eight manufacturers of anti-fungal medications to ensure that adequate supplies are available to treat individuals with fungal meningitis in Florida. The Departments sent letters to the manufacturers of Voriconazole and Amphotericin B, asking the companies to communicate closely with the states that have identified cases of fungal meningitis and to guard against attempts to hoard or artificially raise the price of medications in the event of a shortage.
"The Florida Department of Health will continue to collaborate with public and private partners to ensure that patients with fungal meningitis related to contaminated steroid injections can receive the recommended CDC medications," said State Surgeon General and Secretary of Health Dr. John Armstrong.
“We will continue to work with our state and federal partners to respond to this outbreak and provide support to the impacted facilities throughout the state,” said DBPR Secretary Ken Lawson.
The Centers for Disease Control and Prevention (CDC) has provided interim treatment guidance for meningitis that references these two medications. Voriconazole is manufactured by Pfizer, Sandoz Inc., Mylan Laboratories Ltd. and Teva Pharmaceuticals. Amphotericin B is manufactured by Astella, Alkopharma USA, Sigma Tau and X Gen Pharmaceuticals. The Food and Drug Administration (FDA) has also contacted the manufacturers of the drugs recommended in CDC treatment protocols, and the manufacturers have not reported any shortage of treatment supplies at this time.
The Departments have notified facilities in the state that may have medications from the New England Compounding Center (NECC) and have urged them to adhere to FDA recall procedures for those products. Additionally, DOH has notified patients who may have received a dose of the potentially contaminated steroid injections from the six identified facilities in Florida.
Any practitioner experiencing difficulty obtaining the medications necessary to treat patients affected by contaminated NECC products should contact the FDA’s Center for Drug Evaluation and Research (CDER) Drug Information Hotline, 1-888-463-6332, or email the CDER at firstname.lastname@example.org.
Patients who are concerned about whether they received a medication from one of the contaminated NECC products and who have experienced any symptoms should contact their health care professional. Symptoms include fever, new or worsening headache, nausea, and/or symptoms consistent with a stroke. Some symptoms may be very mild in nature. Fungal meningitis is not contagious and occurs when the protective membranes covering the brain and spinal cord are infected with a fungus.
DOH and DBPR will continue to update their websites at http://newsroom.doh.state.fl.us/ or http://www.myfloridalicense.com/dbpr/. A toll-free hotline is also available at 1-866-523-7339 for those who may have additional questions.
Tallahassee, FL - October 9, 2012 - A precautionary voluntary recall of all New England Compounding Center (NECC) products distributed since January 2012 has been issued by the company, in coordination with the Food and Drug Administration (FDA). This recall is in addition to the October 5th recall of the three contaminated lots of NECC methylprednisolone acetate used for epidural back injections. The numbered contaminated lots are 05212012@68, 06292012@26 and 08102012@51. These lots have been associated with a non-contagious fungal meningitis outbreak. All contaminated lots and NECC products should be returned in accordance with FDA recall procedures.
"We continue to be vigilant in our efforts to protect the health and safety of Floridians,” said State Surgeon General and Secretary of Health Dr. John Armstrong. “We are working in collaboration with the Centers for Disease Control and Prevention (CDC), our health partners and the Department of Business and Professional Regulation (DBPR) to ensure that no NECC medications are present in any health care setting in Florida."
The CDC has expanded the timeline and scope of injection risk to include any patients known or suspected to have received back or joint injections with the suspect lots of NECC methylprednisolone acetate since May 21, 2012. If symptomatic, these patients should be evaluated immediately by their health care professional and monitored or treated as necessary. Patients without symptoms should be evaluated by their health care professionals as soon as possible. This meningitis cannot be spread from person to person. At this time, there has not been a case of septic arthritis related to contaminated steroid joint injections.
Florida health professional associations are also assisting with disseminating updated public health information to their members and patients.
Of the eight Florida facilities identified as having received shipments of the three contaminated steroid lots, two have stated that they have not used these medications (Interventional Rehab Center in Pensacola and North County Surgicenter in Palm Beach).
The remaining six facilities are:
• Florida Pain Clinic, Ocala, FL
• Marion Pain Management Center, Ocala, FL
• Orlando Center for Outpatient Surgery, Orlando, FL
• Pain Consultants of West Florida, Pensacola, FL
• Surgery Center of Ocala, Ocala, FL
• Surgical Park Center, Miami, FL
Symptoms to look for:
Infected patients have presented approximately one to four weeks following their injections with a variety of symptoms including but not limited to: fever, new or worsening headache, neck pain, nausea and/or new symptoms consistent with a stroke (including weakness on one side of the body and slurred speech). Some of these symptoms may be mild, yet should still be reported to a health care professional.
As of 2 PM October 7, the CDC lists 91 cases and seven deaths of meningitis across nine states linked to contaminated steroidal injections of methylprednisolone acetate. Four of these patients are in Florida, and all four reside in Marion County.
The Florida Department of Health and DBPR’s Devices, Drugs, and Cosmetics (DDC) program will continue to notify all Florida health care facilities and practitioners of this expanded list of NECC recalled products. The staff of these facilities will continue contacting patients who have received these injections since May 21, 2012.
We will continue to update our websites at http://newsroom.doh.state.fl.us/ or www.myfloridalicense.com and have set up a toll-free hotline at 1-866-523-7339 for those who may have additional questions. To view FDA’s product list as of Oct. 7, please visit: http://www.fda.gov/DRUGS/DRUGSAFETY/ucm322752.htm. To view the CDC’s list of Florida facilities involved, please visit http://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2012/10/10-06-12-FLORIDA-LIST-WITH-NECC.pdf.
The Florida Department of Health works to protect, promote and improve the health of all people in Florida through integrated state, county and community efforts. Follow us on Twitter at @HealthyFla and on Facebook. For news story ideas, interviews, videos and more from DOH Communications visit the DOH Online Newsroom.
Tallahassee, FL - October 8, 2012 - Based on the latest information from the Centers for Disease Control and Food and Drug Administration, the Department of Health and the Department of Business and Professional Regulation today strongly advise all Florida health care facilities and practitioners to stop using any products from the New England Compounding Center (NECC). These products should be pulled from shelves immediately and not used until the CDC and the FDA make determinations that the products are safe.
This recommendation is in addition to the recall of three lots of NECC Methylprednisolone Acetate received in Lot Nos. 05212012@68, 06292012@26 and 08102012@51 which should be returned in accordance with FDA recall procedures. These three lots have been associated with Aspergillus meningitis following epidural back injections. These medications are not used for epidural analgesia in labor and delivery. This meningitis is not contagious and cannot be spread from person-to-person.
Any patients known or suspected to have received back injections with NECC Methylprednisolone Acetate from the suspected lots should be evaluated immediately by their health care professional and monitored or treated as necessary. The FDA’s list of recalled products related to the meningitis outbreaks is online at: http://www.fda.gov/DRUGS/DRUGSAFETY/ucm322752.htm
The departments have notified all eight Florida facilities who received contaminated Methylprednisolone Acetate, and all suspected lots have been removed. The departments continue to communicate jointly to all other facilities that may have any products from the NECC. Facilities and practitioners should immediately stop using any NECC products until the CDC and the FDA make determinations that the products are safe. A list of facilities who may have received any products from the NECC is online at: http://www.myfloridalicense.com/dbpr/os/communications_office/documents/documents/100612FLORIDALISTWITHNECC.pdf
The Department of Health has set up a toll-free hotline at 1-866-523-7339 for those who may have additional questions. Health care facilities with questions about how to identify affected products or how to dispose of any products may visit the Division of Drugs, Devices and Cosmetics' webpage at http://www.myfloridalicense.com/dbpr/ddc/index.html for additional information.
The Division of Drugs, Devices and Cosmetics safeguards the health, safety and welfare of the citizens of the state of Florida from injury due to the use of adulterated, contaminated or misbranded drugs, drug ingredients and cosmetics by administering the provisions of the Florida Drug and Cosmetic Act (Chapter 499, F.S.).