# 6637
This afternoon we’ve another twist to the fungal meningitis outbreak that’s been linked to steroids dispensed by a Massachusetts compounding pharmacy, as the FDA issues a warning about two other drugs from that facility that may also have contamination issues.
FDA Statement on Fungal Meningitis Outbreak
[10-15-2012] As a result of FDA, CDC, and state health departments’ ongoing investigation of contamination at the New England Compounding Center’s (NECC) Framingham, Massachusetts facility, on October 4, the FDA advised providers to not use any NECC products. On October 6, NECC announced a recall of all its products. A complete list of all products subject to this recall can be accessed here [HTML | PDF]. The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use.
Also as a result of the ongoing investigation of NECC, a patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance and reported to FDA. Triamcinolone acetonide is a type of steroid injectable product made by NECC. The cases of meningitis identified to date have been associated with methylprednisolone acetate, another similar steroid injectable product.
In addition, two transplant patients with Aspergillus fumigatus infection who were administered NECC cardioplegic solution during surgery have been reported. Investigation of these patients is ongoing; and there may be other explanations for their Aspergillus infection. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.
FDA continues to evaluate these reports, and when the agency obtains additional information, it will be promptly relayed to the public. FDA has not confirmed that these three infections were, in fact, caused by an NECC product.
For more on this story we turn to Maggie Fox of NBC News:
More drugs implicated in fungal meningitis outbreak
By Maggie Fox, NBC News
Two more drugs have been implicated in the ongoing outbreak of fungal meningitis linked to contaminated pain injections, federal health officials said Monday.
Both come from the same pharmacy, New England Compounding Center, that distributed the steroids suspected of sickening at least 205 people and killing 15 of them, the Food and Drug Administration said in a statement.
The CDC has posted updated numbers on the expanding outbreak of fungal meningitis linked to potentially contaminated steroid injections. Cases have now been detected in 15 states (Pennsylvania was added today).
Of particular note, there are now 2 confirmed cases of peripheral joint infection (e.g. knee, hip, elbow, shoulder ) reported, in addition to 212 meningitis cases.
A reminder: This type of meningitis is not transmissible between people. Those who did not receive a steroid injection from one of the suspect lots are not at risk of infection.
The CDC continues to advise:
Patients and clinicians need to remain vigilant for onset of symptoms because fungal infections can be slow to develop. In this outbreak symptoms typically have appeared 1 to 4 weeks following injection, but it’s important to know that longer and shorter periods of time between injection and onset of symptoms have been reported. Therefore, patients and physicians need to closely watch for symptoms for at least several months following the injection. See updated Patient Guidance for more information, and contact your physician if you are concerned you may have become ill from your injection.
Complicating matters, the primary fungus identified so far - Exserohilum - while common in the environment – has never been associated with meningitis before.
Doctors are working on new treatment protocols, but as the CDC’s Incident Manager for this outbreak, J. Todd Weber MD stated last week, “This is new territory for public health and the clinical community.”
For health care practitioners , the CDC has scheduled another Clinician’s Outreach Call (COCA) for tomorrow afternoon (Oct. 16th). Details at the link below:
Finally, the following guidance documents have been updated, or added, on the CDC site over the past two days.
UPDATED: Interim Treatment Options for Septic Arthritis Associated With Injection of Potentially Contaminated Steroid Products
October 15, 2012 12:00 PM EDT
UPDATED: Interim Treatment Guidance for Central Nervous System (CNS) and/or Parameningeal Infections Associated with Injection of Potentially Contaminated Steroid Products
October 15, 2012 12:00 PM EDT
UPDATED: Role of Antifungal Prophylaxis in Asymptomatic Patients
October 14, 2012 8:00 PM EDT
NEW: What Should Physicians Be Doing?
October 14, 2012 8:00 PM EDT
UPDATED: Frequently Asked Questions for Clinicians
October 14, 2012 8:00 PM EDT
UPDATED: Instructions for Clinicians Regarding Diagnostic Testing and Specimen Shipping for Central Nervous System and Parameningeal Infections
October 14, 2012 6:00 PM EDT
NEW: Interim Guidance for Management of Asymptomatic Persons Exposed to Potentially Contaminated Steroid Products
October 14, 2012 6:00 PM EDT
NEW: Interim Treatment Options for Septic Arthritis Associated With Injection of Potentially Contaminated Steroid Products
October 14, 2012 6:00 PM EDT
NEW: Interim Treatment Guidance for Central Nervous System (CNS) and/or Parameningeal Infections Associated with Injection of Potentially Contaminated Steroid Products
October 14, 2012 6:00 PM EDT
