Update: The recall has been expanded to include ALL NECC injectable products.
The outbreak of fungal meningitis first became known on September 21, 2012 when the Tennessee Department of health notified the Center for Disease Control that a patient developed meningitis around 19 days after being injected with an epidural steroid at a Tennessee ambulatory surgical center.
Within 4 days the New England Compounding Pharmacy recalled three lots of its methylprednisolone acetate. This was primarily used to inject into the spinal column for pain relief. Just three days ago the US Recall News published an update called Steroid Meningitis Outbreak Update. (source)
At that time they referenced 185 fungal meningitis cases over 12 states with 14 deaths. As of 6:25 PM 10/14/2012 there were 205 cases with 15 dead. ( CDC cases and death by state and date) How many more will die and get sick is a guestimate that no one is prepared to make. However estimates are that 14000 people have been given the tainted steroid.
When Were the First Steroid Shots Given
Us Recall News also had an apparent error when it reported that “if you received an epidural injection on or after Sept 26, 2012 you should contact your doctor to find out the lot number on the steroid bottle. In fact the CDC’s own guidance states:
Doctors should contact patients who have received medicines associated with three lots of preservative-free methylprednisolone acetate (80mg/ml) from the NECC that were recalled on September 26, 2012. Thedate now given for the start of the tainted injections is given starting May 21, 2012. See Clinician Guidance for more information, including new case definitions.
Who Has Been Implicated as Causing This Outbreak of Meningitis
The NECC New England Compounding Center has been implicated as the compounding pharmacy that provided the steroids. Cultures from patients as well as testing of some of the files of specific batches from NECC show the fungus. In fact the cultures are still being studies in labs for any other evidence that can help with treatment.
In fact the NECC recalled all of it steroid batches of Methlprednisolone Acetate. The specific lot numbers were also listed. These numbers are 050212012, 06292012 and 08102012.
The NECC has asked for a massive recall of its drug products. These include painkillers, steroids and many others.
According to the FDA’s latest update of October 12, 2012:
They also found fungus in sealed NECC vials of the steroid collected from around the country. What is so far unknown is how the fungus got in the vials, where it came from and where the original powder steroid was purchased. As a compounding pharmacy the NECC takes a dry steroid and turns in into an injectable liquid.
FDA, in partnership with CDC, is trying to figure out how the fungus matches with the fungus taken from patient cultures. So far there have been two types of fungus cultured from patients as will be discussed below.
As part of the ongoing investigation, FDA’s investigators have collected samples of materials from the NECC facility in Framingham, Massachusetts, and from clinical facilities around the country that reported ill patients and/or had retained quantities of methylprednisolone acetate compounded by NECC. FDA is looking at the process and procedures in the compounding process. What is understood is that these dry powder come in on pallets. It is unknown if the pallets have been tested for presence of the fungus. This was confirmed in a response I received from the Oho Department of Health to a Public Records request on issues related to the crisis. See the response immediately below.
Dear Mr. Castelli:
This letter is to inform you that the Ohio Department of Health (“Department”) received your record request for information with respect to the above referenced matter. The Department will forward your request to the proper personnel. However, keep in mind that the Department does not directly regulate Ohio’s pharmacies. Instead, the Ohio State Board of Pharmacy (“Board”) has regulatory authority and most of your question will be better directed to the Board. The Board’s contact information is below:
Ohio State Board of Pharmacy
77 S High Street Room 1702
Columbus, OH 43215
Phone: 614-466-4143
Fax: 614-752-4836
TTY/TDD Ohio Relay Service: 1-800-750-0750
Or you may send the Board an email using the follow webpage: https://pharmacy.ohio.gov/Contact.aspx
To the extent the Department has any responsive documents, they will be provided to you. Be advised that the Department does not confirm or otherwise comment upon or discuss information in a manner that would identify an individual. Individually identifiable health information that may be in the possession of the Department will not be provided without a specific authorization bearing an original signature from the individual who is the subject of the information. R.C. 3701.17. A general or photocopied authorization for the release of medical or other information is not sufficient for the release of information pursuant to R.C. 3701.17.
One of the allegations against NECC is that they were making these batches in bulk. According to regulators they were only supposed to make this on a per prescription basis. So far Massachusetts and Ohio have suspended their license. In Ohio it is the state department of pharmacy that controls their operation
So NECC is clearly in the sights of regulators and attorneys as well as State attorney generals. Additionally the sister corporation Ameridose as well as Alaunus Pharmaceutical LLC, which distributed drugs for Ameridose may have some role or corporate governance issues could play a part as Conigliaro and Cadden have ownership interests in all three of the companies. So the interrelationship and control of these companies is an issue that is being looked at.
What Fungus Has Been Identified and How is it Treated
CDC has recognized the presence of the fungus Exserohilum in multiple clinical specimens from people with meningitis. At this time, only one clinical specimen has tested positive for the fungus Aspergillus.
Current treatment guidance is also given by the CDC. In part the guidance discusses that:
There is significant evidence that Exserohilum rostratum (a brown-black mold) is the predominant pathogen in this outbreak. They have gone to the mecical literature and found voriconazole may be effective in treating infections due to brown-black molds, as well as infections due to Aspergillus species. They also base treatment suggestions on the anatomic site of infection and pharmacokinetics of antifungal agents. The CDC is also consulting with national experts. Though some commentators have suggested we are in uncharted water here in terms of incubation of the disease as well as treatment.
I have seen statements to the effect that even if you test negative for meningitis you still may develop it due to the subtle nature to go undetected. So even if you have been cleared you may still not be out of the water. Guestimates are that if no symptoms appear within 4 weeks after the shot that you are unlikely to develop meningitis. but other places I have seen you must be vigilant for months.
For more information about this outbreak please consider the following resources:
Mr. Castelli’s web site
FDA web site
CDC web site
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