MMWR: Invasive Meningococcal Disease Among MSM In New York City

Meningitis Cases in New York City

Health department is recommending vaccination for certain men at high risk for meningitis. For the latest information, visit the New York City Department of Health and Mental Hygiene.  Photo Credit CDC  Meningococcal Disease

 

 

# 6826

 

Last October, in NYC: The Other Meningitis Outbreak, I wrote about an ongoing outbreak of bacterial meningitis that had been reported in New York City among certain HIV positive men who had sex with other men (MSM).

 

Six weeks later, after two more infections had come to light, the New York City Health Department issued a statement recommending that certain MSM – regardless of their HIV status -  get the meningitis vaccine.

 

 

Health Department Expands Vaccination

Recommendations for Men at Greatest Risk for Contracting Meningitis

Two new cases of meningitis among men who have sex with men were reported over the past five weeks

November 29, 2012 – The Health Department issued new recommendations today for vaccinating against invasive meningococcal disease – commonly known as meningitis – after an increase in cases. Vaccinations are now advised for men, regardless of HIV status, who have had intimate contact with another man that he met through a website, digital application (“App”), or at a bar or party since September 1, 2012 AND live in the following neighborhoods: Bedford-Stuyvesant, Brownsville, Bushwick, Clinton Hill, Crown Heights, Downtown Brooklyn, Dumbo, East New York, Prospect Heights and Williamsburg.

(Continue . . . )

 

Vaccination can help prevent infection, but does not treat an active infection. A person can be a carrier, and transmit the infection, without falling ill themselves (cite).

 

Treatment is with antibiotics and steroids, but even with treatment, 10%-15% of patients may die. Severe neurological sequelae may occur as well.

 

Which brings us to a Notes From The Field report in the most recent MMWR.

 

Notes from the Field: Serogroup C Invasive Meningococcal Disease Among Men Who Have Sex With Men — New York City, 2010–2012

Weekly

January 4, 2013 / 61(51);1048-1048

On September 27, 2012, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) alerted health-care providers and the public about 12 cases of invasive serogroup C Neisseria meningitidis disease (SCMD) occurring in NYC since August 2010 among men who have sex with men (MSM). Cases were identified through existing mandatory notifiable disease reporting and classified according to the Council of State and Territorial Epidemiologists case definitions (1). By December 31, 2012, a total of 18 cases had been identified among MSM. For 2012, the incidence rate of invasive meningococcal disease among MSM aged 18–64 years was 12.6 per 100,000 persons, compared with 0.16 among non-MSM males aged 18–64 years. MSM and non-MSM population denominators were obtained from the 2010 NYC Community Health Survey (2) a telephone-based survey of approximately 10,000 NYC residents.

 

All 18 patients were hospitalized, and five deaths occurred. The age range among patients was 21–59 years (median: 32 years). Nine lived in Brooklyn, four in Manhattan, two in the Bronx, and two in Queens; one was homeless. Nine were black, and four were Hispanic. Ten were infected with human immunodeficiency virus (HIV), including eight of 12 cases reported during 2012. Eleven of 12 isolates were closely related (>85%) by pulsed field gel electrophoresis (3) to a strain from a 2006 SCMD outbreak in Brooklyn (4); the last six out of seven patients' isolates were indistinguishable from each other. At least seven patients had met multiple sexual partners online.

 

On October 4, 2012, DOHMH recommended administration of meningococcal vaccine to HIV-infected male NYC residents who had intimate contact with any man met online, through a smartphone application, or at a bar or party since September 1, 2012. On November 29, DOHMH expanded its recommendation to HIV-uninfected men with the same high-risk behaviors who reside in areas of Brooklyn where recent cases have clustered. In addition, DOHMH publicized this outbreak among the population at risk through advertising, mass e-mail messages on MSM websites, posters distributed at MSM bars and clubs, and outreach to community leaders and physician's groups.

 

More information regarding invasive meningococcal disease and this outbreak is available on the CDC and DOHMH websites (5). Public health departments should be alert for cases of SCMD in MSM and should ask SCMD patients about sexual history, travel history (including travel to NYC), and HIV status to help determine if this outbreak is spreading to other juridictions.

 

For more information, the CDC maintains an extensive website on Meningococcal Disease.

 

»» Read More

CDC HAN Update On Fungal Meningitis Outbreak

 

Photo Credit FDA

# 6796

 

While the number of new meningitis cases linked to contaminated steroid injectables produced by NECC have slowed in recent weeks after their recall in late September, the number of slower-to-develop  paraspinal/spinal & peripheral joint (site of injections) infections continues to rise.

 

 

 

In many cases, the symptoms of fungal infection are subtle - and since these patients (by definition) already had joint/spinal pain when they received these injections - it isn’t always easy to identify patients who develop pockets of these slow growing organisms.

 

The CDC, in reviewing diagnostic imaging of a number of patients who received these injections, has determined that there may be a substantial number of as-yet unrecognized infections out there. 

 

So today they have issued a HAN Health Update.

 

 

December 20, 2012, 11:55 ET (11:55 AM ET)
CDC HAN-0338-2012-12-20-U-N

Update: Multistate Outbreak of Fungal Infections among Persons Who Received Injections with Contaminated Medication

Summary
New information from diagnostic imaging of patients exposed to contaminated methylprednisolone acetate (MPA¹) from the New England Compounding Center (NECC) in Framingham, Mass., demonstrates the need for assertive clinical evaluation of these patients for the possibility of an unrecognized, localized spinal or paraspinal infection. This Health Alert Network (HAN) notice provides updated guidance and information about the ongoing multistate outbreak of fungal infections as follows:

• CDC and state partners have analyzed new preliminary data based on recent Magnetic Resonance Imaging (MRI) studies among patients who had spinal or paraspinal injection with contaminated MPA from NECC. These findings demonstrate that among patients with no previous evidence of infection, and with new or worsening symptoms at or near the site of their injection, more than 50% had findings suggestive of a localized spinal or paraspinal infection, including epidural abscess, phlegmon, arachnoiditis, discitis, or vertebral osteomyelitis.
• This new information suggests that some patients who received spinal or paraspinal injections with implicated MPA from NECC may currently have an unrecognized, localized spinal or paraspinal infection.
• CDC is therefore re-emphasizing the guidance from the November 20 HAN advisory that recommended clinicians remain vigilant for evidence of fungal infection in these patients and use an assertive approach for clinical management and follow-up of these patients. CDC continues to recommend MRI with contrast of the symptomatic area(s) in patients with new or worsening symptoms at or near their injection site following spinal or paraspinal injection of implicated MPA.
• In addition, CDC is recommending that clinicians should consider obtaining an MRI with contrast of the injection site in patients with persistent but baseline symptoms because the presentation of these spinal or paraspinal infections can be subtle and difficult to distinguish from a patient’s baseline chronic pain.

 

(Continue . . .)

 

 

The CDC’s Health Alert Network (HAN) is designed to ensure that communities, agencies, health care professionals, and the general public are able to receive timely information on important public health issues.

 

You can sign up for HAN messages, and scores of other CDC and HHS email notifications, by going to the CDC - Quick Subscribe GovDelivery page.

 

There are 4 types of HAN releases, starting from the highest priority to the lowest.

• Health Alert - Conveys the highest level of importance; warrants immediate action or attention.
• Health Advisory - Provides important information for a specific incident or situation; may not require immediate action.
• Health Update - Provides updated information regarding an incident or situation; unlikely to require immediate action.
• Info Service -Provides general information that is not necessarily considered to be of an emergent nature.

 

Complicating matters, last week the FDA updated their list of contaminates detected in injectable drugs produced by this compounding pharmacy.

 

Laboratory Testing and Results

 

[12-12-2012] FDA and CDC have identified bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC. These include bacteria known as Bacillus, and fungal species including Aspergillus tubingensis,  Aspergillus fumigatus,  Cladosporium species,and Penicillium species.

Although rare, some of the identified Bacillus species can be human pathogens.  Some of the fungal organisms identified, particularly Aspergillus fumigatus, are known to cause disease in humans.  It is not known how product contamination with these organisms could affect patients clinically.

 

»» Read More

Referral: McKenna On The Steroid-Linked Meningitis Outbreak

CDC update 12/3/12

 

# 6762

 

Maryn McKenna, writing on her Superbug Blog this morning, has the details of a special briefing provided to her and others from the Association of Health Care Journalists by the CDC on the multi-state meningitis outbreak linked to contaminated steroid injections.

Follow the link to read:

 

Fungal Meningitis From Injections: Not Even Close To Over

• By Maryn McKenna
• 12.04.12
• 9:30 AM

»» Read More

CDC Update Of Fungal Meningitis Cases

 

# 6717

 

The CDC - which now issues updates on Mondays, Wednesday, and Friday - indicates that 23 new cases of fungal infection from contaminated steroids have been identified since last Friday’s report (Monday was a Federal Holiday).

 

*451 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus 10 peripheral joint infections (e.g., knee, hip, shoulder, elbow). No deaths have been associated with peripheral joint infections.

 

The bulk of these newly identified cases (20) are listed as coming from Michigan, although no details are given.  A quick check of the Michigan Department of Health’s website still shows case counts current as of November 9th.

 

As of November 9, 2012, Michigan's case count associated with the Centers for Disease Control and Prevention multi-state meningitis investigation is 128 total cases and eight deaths [64 cases of meningitis, eight deaths*, 57 epidural abscess, one stroke and six joint infections].

 

Since these reports don’t tell us the date of onset of symptoms, we really can’t tell how many of these cases are `new’ in the past couple of weeks, and how many are older, but just now being identified. 

 

The assumption is that no contaminated steroids were administered to patients after the recall notice was announced in late September.

 

The danger of developing meningitis is believed greatest during the first six weeks after injection, so there is some hope that the number of new cases will begin to decline soon.

 

We’ve also seen reports of epidural abscesses and arachnoiditis among some of these patients. These are localized pockets of fungal infection that are slow to grow, difficult to identify, and even more difficult to treat.

 

The CDC updated their Frequently Asked Questions for Clinicians late last week, with the following information.

Epidural Abscess and Arachnoiditis

There have been media reports of spinal epidural abscesses and arachnoiditis among patients who received treatment for meningitis. What are these conditions and their symptoms?

CDC has received preliminary reports of spinal epidural abscesses and arachnoiditis occurring among a portion of patients undergoing treatment for fungal meningitis due to this outbreak. CDC does not know at this time how many patients developed these disorders or why they occurred.  Both conditions are rare but serious disorders in the general population that require prompt medical attention. 

• A spinal epidural abscess is characterized by inflammation and a collection of pus around the spine. Spinal epidural abscesses sometimes result in swelling in the affected area (e.g., near the site where contaminated steroid mediation was injected).
  • Common symptoms can include fever, headache, back pain, and neurological problems (e.g., weakness, unusual changes in sensation)
• Arachnoiditis is a disorder caused by the inflammation of the arachnoid, one of the membranes that surrounds and protects the nerves of the spinal cord. The condition can be caused by irritation from chemicals, infection, or direct injury to the spine.
  • Symptoms can include numbness, tingling, and a characteristic stinging and burning pain in the lower back or legs.  Some people with arachnoiditis may have debilitating muscle cramps, twitches, or spasms.  The condition may also affect the bladder, bowel, and sexual function.  In severe cases, arachnoiditis may cause paralysis of the lower limbs. 
  • For more information about arachnoiditis, see the National Institute of Neurological Disorders and Stroke’s website.

 

The emergence of these new syndromes linked to fungal tainted steroid injections adds yet another level of uncertainty for those who are waiting to see if they will develop symptoms.

 

And finally, the head of the embattled pharmacy that created and distributed these steroid products appeared before a congressional committee today, but declined to testify.   This from the Boston Globe.

 

 

Pharmacy head pleads Fifth at meningitis outbreak hearing

WASHINGTON Barry Cadden, the owner and director of the specialty pharmacy tied to deadly fungal meningitis outbreak declined to testify Wednesday morning before a congressional committee investigating the matter.

»» Read More

CDC HAN Advisory: Additional NECC Products Found Contaminated

# 6690

 

 

Last night the CDC – as part of their investigation into the multistate fungal meningitis outbreak linked to contaminated steroid products distributed by the New England Compounding Center (NECC) -  issued a pair of HAN Advisories. 

 

• The first, is a notification that two additional products produced by NECC (betamethasone and cardioplegia solution) have tested positive for bacterial contamination.  
• The second advisory is essentially a HAN version of the FDA’s announcement on Wednesday of a total recall of all Ameridose products.  Ameridose is a a sister company to NECC.

 

The CDC’s Health Alert Network (HAN) is designed to ensure that communities, agencies, health care professionals, and the general public are able to receive timely information on important public health issues.

 

You can sign up for HAN messages, and scores of other CDC and HHS email notifications, by going to the CDC - Quick Subscribe GovDelivery page

 

There are 4 types of HAN releases, starting from the highest priority to the lowest.

 

• Health Alert - Conveys the highest level of importance; warrants immediate action or attention.
• Health Advisory - Provides important information for a specific incident or situation; may not require immediate action.
• Health Update - Provides updated information regarding an incident or situation; unlikely to require immediate action.
• Info Service -Provides general information that is not necessarily considered to be of an emergent nature.

 

Yesterday, the CDC also updated the number of confirmed infections due to these contaminated pharmaceuticals, which now total 377 cases of fungal meningitis, and 9 peripheral joint infections.

 

 

 

The following are excerpts from last night’s HAN Advisory on NECC contamination issues.

 

Contamination Identified in Additional Medical Products from New England Compounding Center

Summary: As part of the ongoing investigation of the multistate outbreak of fungal meningitis and other infections, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) continue to test medical products from the New England Compounding Center (NECC) in Framingham, Mass.

NECC is the firm that distributed and recalled injectable steroid medications implicated in the current outbreak of fungal meningitis and other infections. CDC and FDA are reporting today that product testing has identified bacterial contamination with several Bacillus species and closely related bacterial organisms in unopened vials of betamethasone and cardioplegia solution that were distributed and later recalled by NECC on October 6, 2012. These bacteria are commonly found in the environment and have been rarely reported as a cause of human disease; it is not known how product contamination with these species might affect patients.

Although clinical infection is possible, CDC has not received reports of laboratory-confirmed cases of infection due to Bacillus or closely related organisms linked to these products. CDC’s recommendations to healthcare providers for diagnosing and treating symptomatic patients who have received NECC products have not changed as a result of these findings. Additional microbial organisms may be identified in recalled NECC products as additional laboratory testing is completed.

<SNIP>

As part of the ongoing investigation, FDA and CDC have been testing various NECC products for evidence of contamination. Laboratory testing at CDC and FDA has found multiple species of Bacillus and closely related bacterial organisms in unopened vials of betamethasone and cardioplegia solution, as shown in the table below.

Medication
Lot number
Microbial contamination

Betamethasone
08202012@141
Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp.

Betamethasone
07032012@22
Bacillus niabensis, Bacillus circulans

Betamethasone
07302012@52
Bacillus lentus, Bacillus circulans

Cardioplegia solution
09242012@55
Bacillus halmapalus, Brevibacillus choshinensis

Other cultures for these products, including fungal cultures, are pending.

Recommendations to Healthcare Providers
CDC and FDA have previously advised that healthcare professionals should cease use of any product produced by NECC. On October 15, FDA issued a MedWatch Safety Alert advising clinicians to follow-up with patients who received any injectable NECC product, including betamethasone or cardioplegia solution purchased from or distributed by NECC after May 21, 2012. Clinicians were also requested to report any suspected adverse events following use of these products to FDA's MedWatch program.

 

CDC continues to investigate reports of potential infections in patients receiving other NECC products. As of November 1, CDC has received no reports of confirmed infections resulting from injection of any NECC product except those from the three recalled lots of preservative-free methylprednisolone acetate.^[1]

 

CDC’s recommendations to healthcare providers for diagnosing and treating symptomatic patients who have received NECC products have not changed as a result of these findings. CDC continues to recommend routine laboratory and microbiologic tests, including bacterial and fungal cultures, deemed necessary by treating clinicians.

 

These bacteria have been rarely reported as a cause of human disease. Nevertheless, clinicians should consider these product findings when reviewing laboratory results from patients who have been exposed to a NECC product, since Bacillus and related bacteria are often considered in clinical results to be possible skin contaminants. Physicians should continue to report infections potentially related to NECC products to FDA’s MedWatch and to state health departments.

---

1. NECC lots of methylprednisolone acetate (PF) 80mg/ml:

• Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012
• Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
• Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013

»» Read More

CDC: Laboratory Test Results From Meningitis Outbreak

 

 

# 6687

 

Last night the CDC posted updated laboratory test results from patients - and un-opened vials of methylprednisolone produced by the New England Compounding Center  – as part of their investigation into a multi-state outbreak of fungal meningitis.

The latest numbers from this outbreak, as of 2pm yesterday, are:

 

Lab tests have isolated Exserohilum rostratum in 52 of the 54 patients with CDC laboratory-confirmed fungal meningitis. Tests by the CDC and FDA have also found Exserohilum rostratum in unopened vials from two of the three recalled lots of injectable steroids produced by NECC.   Tests are pending on the third lot.

 

Here’s the complete CDC Update:

 

Laboratory Testing and Results from the Outbreak

October 31, 2012 6:00 PM EDT

CDC laboratory-confirmed results found on this page are from three New England Compounding Center (NECC) preservative-free methylprednisolone  acetate (MPA) lots recalled on September 26, 2012.(1)

CDC scientist examines microscopic slides showing Exserohilum rostratum (on screen) during the multistate meningitis outbreak.

CDC's Fungus Reference Laboratory has the capacity and technology to examine fungal isolates under the microscope and to confirm their identification using DNA sequencing methods.

• For the multistate outbreak, the fungus laboratory is working with the Clinical and Environmental Microbiology Branch, Division of Healthcare Quality Promotion, to detect and identify other microbial pathogens. In addition, the Infectious Diseases Pathology Branch, Division of High-Consequence Pathogens and Pathology, is examining tissues from biopsies and autopsy materials.
• CDC and the states are testing tissue and fluid samples from patients with probable or confirmed fungal infection. CDC scientists are looking to see if the samples contain fungi and other microbial pathogens, and if so, what type.
• In addition, FDA and CDC are testing vials of NECC preservative-free MPA to see if they contain fungi and other microbial pathogens and if so, what type.

CDC Laboratory Results

As of October 22, 2012, Exserohilum rostratum has been found in clinical specimens for all but two of the 54 patients with CDC laboratory-confirmed fungal meningitis who meet the confirmed case definition.(2)

 

Tests at CDC and FDA laboratories on the preservative-free MPA vials have confirmed the presence of the same fungus, Exserohilum rostratum, in unopened vials from two of the three recalled lots.(1) Testing on the third lot of preservative-free MPA is ongoing. These laboratory test results strengthen the link between preservative-free MPA vials and the outbreak.

 

The fungi found in both patients and in recalled vials are common in the environment but were not recognized as a cause of meningitis before this outbreak.

»» Read More

FDA Statement On Conditions Reported At NECC Facility

 

Photo Credit CDC

 

 

# 6669

 

The FDA has released a report citing the conditions they observed at the New England Compounding Center, the compounding pharmacy who’s steroid products are linked to a multistate fungal meningitis outbreak.

 

The report cited finding unopened vials of preservative-free methylprednisolone during an inspetion on October 2nd that were observed to have `greenish black foreign matter’ and/or `white filamentous material’ inside.

 

Additional testing `confirmed the presence of viable microbial growth in 50/50 vials tested’.

 

It’s an 8-page report, and may be read in its entirety at this link.  Here is the FDA press announcement.

 

 

 

FDA NEWS RELEASE

For Immediate Release: Oct. 26, 2012
Media Inquiries: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA reports conditions observed at New England Compounding Center facility

Today, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.

 

The investigators also observed problems with NECC’s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination. Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container.

 

The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations.

 

The 483 does not constitute a final FDA determination that any observation listed on the 483 is a violation of the Federal Food, Drug, and Cosmetic Act or any related regulations.

 

The FDA considers the 483 along with an Establishment Inspection Report (EIR), prepared by FDA investigators, and any other relevant information, including any responses received by the company. The agency then considers whether further action, if any, is appropriate. The inspection report for NECC has not been completed and is not being shared at this time.

 

The FDA continues to work closely with the U.S. Centers for Disease Control and Prevention and state partners, including the Massachusetts Board of Registration in Pharmacy, to investigate the outbreak of fungal meningitis among patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid.

For more information: 

• FDA Form 483 for New England Compounding Center
• FDA Form 483: Frequently Asked Questions
• FDA Inspections, Compliance, Enforcement, and Criminal Investigations
• Update on Fungal Meningitis

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CDC Fungal Meningitis Update – Oct. 26th

# 6668

 

The CDC has posted Friday’s update on the number of cases, and deaths, associated with contaminated steroid injections produced by a Massachusetts compounding pharmacy. 

 

The highest risk period according to the CDC is within the first 6 weeks following injection. Since the suspect lots of steroids were identified and recalled a month ago, it is hoped the number of new cases will begin to decline in the next few weeks.  

 

That said, no one knows for sure how long before a person can be declared `out of the woods’. 

 

During a similar incident in 2002, one case did not develop signs of infection until nearly 6 months after exposure (see Revisiting An Earlier Fungal Meningitis Outbreak).

 

The CDC breaks down today’s numbers:

331 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus 7 peripheral joint infections (e.g., knee, hip, shoulder, elbow). No deaths have been associated with peripheral joint infections.

 

For more details on the ongoing investigation, and clinical and patient guidance documents, you can visit the CDC’s website:

 

Multistate Fungal Meningitis Outbreak Investigation

»» Read More

CDC HAN Advisory & Updates On Fungal Meningitis

 

*304 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus 4 peripheral joint infections (e.g., knee, hip, shoulder, elbow). No deaths have been associated with peripheral joint infections.

 

# 6658

 

Proof this morning that they are burning the midnight oil over at the CDC - as they issued no fewer than seven updates on the fungal meningitis outbreak at 11pm last night – including an updated HAN Advisory.

 

Six of the seven are guidance documents are designed for practitioners treating exposed, or infected, patients, while the final one is an updated Q&A for patients.

 

NEW: Health Alert Network (HAN) - Oct 23, 2012 Tuesday, October 23, 2012 11:00 PM

 

UPDATE: Interim Treatment Guidance for Central Nervous System (CNS) and Parameningeal Infections Associated with Injection of Contaminated Steroid Products Tuesday, October 23, 2012 11:00 PM

 

UPDATE: Interim Treatment Guidance for Osteoarticular Infections Associated With Injection of Contaminated Steroid Products Tuesday, October 23, 2012 11:00 PM

 

UPDATE: Interim Guidance for Management of Asymptomatic Persons Exposed to Potentially Contaminated Steroid Products Tuesday, October 23, 2012 11:00 PM

 

NEW: Guidance on Management of Asymptomatic Patients Who Received Epidural or Paraspinal Injections with Contaminated Steroid Products Tuesday, October 23, 2012 11:00 PM

 

UPDATE: Frequently Asked Questions for Clinicians: Multistate Fungal Meningitis Outbreak Investigation Tuesday, October 23, 2012 11:00 PM

 

UPDATE: Frequently Asked Questions for Patients: Multistate Fungal Meningitis Outbreak Investigation Tuesday, October 23, 2012 11:00 PM

 

 

The stickiest issue for the CDC, patients, and physicians has been whether to institute some kind of prophylactic anti-fungal treatment in those who have been exposed, but are thus far asymptomatic.

 

And if the drugs needed were well tolerated, and plentiful in supply, that might be an option.

 

But the truth is, taking these anti-fungal drugs is not without risk, as they have been linked to liver, heart, and kidney damage. 

 

Simply put, they are not something you’d want to take for several months, unless you had to.

 

And there are also concerns that there may not be sufficient supply of these drugs to provide prophylactic treatment to 14,000 patients.

 

So far, of the 14,000 patients believed exposed, just 2.2 % have developed symptoms.

 

While that number will likely rise, the CDC believes that patients who have gone more than 42 days since their last injection without showing signs of illness are at a substantially reduced risk of developing meningitis.

 

Therefore the CDC continues to advise against prophylactic treatment of asymptomatic individuals who may have been exposed.  

 

This excerpt from last night’s HAN advisory.

 

October 23, 2012, 22:00 ET (10:00 PM ET)
CDCHAN-00330-2012-10-23-UPD-N

Issuance of Guidance on Management of Asymptomatic Patients Who Received Epidural or Paraspinal Injections with Contaminated Steroid Products

CDC analysis suggests that the period of greatest risk for development of fungal meningitis among patients who received epidural or paraspinal injections with contaminated products¹ is during the first 6 weeks (42 days) after injection; therefore, additional monitoring of these patients should be considered. Accordingly, CDC provides guidance for asymptomatic patients who received epidural or paraspinal injections with contaminated steroid product¹ within the last 6 weeks (42 days), and those who received such products longer than 6 weeks (42 days) ago. For specific details about the updated guidance, see Guidance on Management of Asymptomatic Patients Who Received Epidural or Paraspinal Injections with Contaminated Steroid Products.

 

As stated above, CDC does not recommend initiation of antifungal treatment in the absence of diagnostic test results indicating fungal meningitis in exposed patients who are asymptomatic. Currently available data do not suggest an added benefit to this approach in comparison to the strategies outlined in the updated guidance, and patients may experience serious adverse drug events associated with treatment.

(Continue . . . )

 

 

Watchful waiting is always difficult, particularly when you are dealing with a potentially fatal condition. But sometimes it really is the lesser of two evils.

 

Patients who go more than 42 days without developing symptoms are believed to be at reduced risk of illness - but as we saw last week (see Revisiting An Earlier Fungal Meningitis Outbreak) during a similar outbreak 10 years ago in South Carolina - infections cropped up as much as six months post-exposure.

 

All of which means that this story, and the ordeal for those exposed, isn’t likely to be over anytime soon.

»» Read More

CDC Fungal Meningitis Update – Oct 22nd

# 6652

 

While there are no additions or changes to guidance documents posted on the CDC’s Meningitis website today, the CDC has updated the number of cases, and deaths, associated with the Multistate Fungal Meningitis outbreak.

 

 

*294 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus 3 peripheral joint infections (e.g., knee, hip, shoulder, elbow). No deaths have been associated with peripheral joint infections.

 

 

Numbers are changing by the hour, as evidenced by this press release from the state of Florida earlier today adding another case to their total (n=18), a 55 year old man who received treatment at pain clinic in Escambia county.  This from the Florida DOH.

 

10.22.12 - Florida Fungal Meningitis Cases Total Eighteen

 

 

A finally, as you might expect - with 23 deaths and hundreds of serious injuries - lawsuits are being filed on behalf of many who received these injections. 

 

For now, the compounding pharmacy that shipped the injectable steroids (NECC) is being named as the sole defendant, but others may be included later.

This from the Wall Street Journal.

 

Lawsuits Mount as Meningitis Deaths Rise

By THOMAS M. BURTON

The compounding pharmacy at the center of a deadly meningitis outbreak is facing a wave of lawsuits from patients who received steroid injections made by the pharmacy.

 

At least 10 lawsuits, including one seeking class action status, have been filed against the New England Compounding Center of Framingham, Mass. Scores more plaintiffs have retained attorneys to commence litigation.

(Continue. . . )

»» Read More

CDC Fungal Meningitis Update – Oct 19th

 

# 6648

 

The latest case counts have been posted by the CDC, and today they are reporting 14 additional cases, and another fatality.

 

 

 

*268 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus 3 peripheral joint infections (e.g., knee, hip, shoulder, elbow). No deaths have been associated with peripheral joint infections.

 

The CDC has also updated some guidance documents since yesterday’s case count, and has posted the audio of Tuesday’s COCA (Clinician Outreach and Communication Activity) call on the outbreak.

 

• UPDATE: Clinician Guidance Thursday, October 18, 2012 6:45 PM

 

• UPDATE: Multistate Fungal Meningitis Outbreak: Healthcare Facilities Thursday, October 18, 2012 4:30 PM

 

• UPDATE: Current Situation - CDC Responds to Multistate Fungal Meningitis Outbreak Thursday, October 18, 2012 3:00 PM

 

 

The COCA call featured briefings by and Q&A with:

Multistate Fungal Meningitis Outbreak Investigation Update: Information and Guidance for Clinicians

Presenter(s):

Melissa K. Schaefer, MD
Medical Officer
Division of Healthcare Quality Promotion
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease and Control and Prevention

Tom Chiller, MD, MPH
Medical Epidemiologist
Division of Foodborne, Waterborne & Environmental Diseases
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease and Control and Prevention

Peter G. Pappas, MD
Professor of Medicine
Division of Infectious Disease
Department of Medicine
University of Alabama at Birmingham 

Overview:

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) continue to work closely with state public health departments on a multistate investigation of fungal meningitis among patients who received an epidural steroid injection. These cases are associated with a potentially contaminated steroid medication prepared by New England Compounding Center (NECC), located in Framingham, Mass. During this COCA Call, subject matter experts will provide updates to the current epidemiology of the outbreak, describe clinical presentation and features of fungal meningitis, and review CDC’s recommended treatment guidance.

 

AUDIO File and TRANSCRIPT available at this link.

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Revisiting An Earlier Fungal Meningitis Outbreak

 

Exserohilum rostratum – Credit CDC

 

 

# 6646

 

One of the basic tenets of modern medicine is Primum non nocere, or `First, do no harm’.  And while that is undoubtedly the goal of every practitioner, sadly, it doesn’t always work out that way.

 

Whether by accident, misdeed, or miscalculation - sometimes a patient’s health is made worse by the treatment they receive from the healthcare system.

 

When that happens it is called an Iatrogenic (from the Greek iatros, physician & genein, to produce) illness or injury.

 

 

HCAIs (Health Care Associated Infections) or HAIs (Hospital Acquired Infections) fall under the Iatrogenic umbrella, and according to the AHRQ :

 

HAIs are the most common complication of hospital care and are one of the top 10 leading causes of death in the United States, accounting for an estimated 1.7 million infections and 99,000 associated deaths in 2002. The financial burden attributable to these infections is estimated at $28 to $33 billion in excess health care costs each year.

 

As we watch the rising number of fungal meningitis cases among recipients of steroid preparations from an New England compounding pharmacy, it may surprise many to learn that a strikingly similar tragedy occurred a decade ago.

 

The year was 2002, and the origin was – once again – a compounding pharmacy, this time in South Carolina.  While number of cases was fewer - and the type of fungus was different - the narrative is hauntingly familiar. 

 

This from the CDC’s MMWR of December 2002:

 

Exophiala Infection from Contaminated Injectable Steroids Prepared by a Compounding Pharmacy --- United States, July--November 2002

In the United States, pharmacists compound medications to meet unique patient drug requirements or to prepare drug products that are not available commercially (1). In September 2002, the North Carolina Division of Public Health (NCDPH) was notified of two cases of meningitis caused by a rare fungus in patients who had received epidural injections at outpatient pain management clinics.

 

This report describes five cases of fungal infection associated with contaminated drugs prepared at a compounding pharmacy. Clinicians should consider the possibility of improperly compounded medications as a source of infection in patients after epidural or intra-articular injections.

 

In this case, the contamination was eventually linked to an improperly maintained and operated autoclave.

 

An investigation of compounding pharmacy A by the South Carolina Board of Pharmacy (SCBP) found improper performance of an autoclave with no written procedures for autoclave operation, no testing for sterility or appropriate checking of quality indicators, and inadequate clean-room practices as outlined in the American Society of Health-System Pharmacists (ASHP) guidance for pharmacy-prepared sterile products (2)

 

Of particular concern was the revelation that: Cases occurred up to 152 days following an injection.

 

The source of suspected contamination at the NECC facility in Massachusetts has not been determined, but yesterday the FDA announced that unopened vials from one of the batches of recalled methylprednisolone acetate were found to harbor Exserohilum rostratum.

 

Last night, the Annals of Internal Medicine published a perspective by John R. Perfect, M.D. who dealt with the South Carolina outbreak ten years ago. Dr. Perfect is Chief of the Division of Infectious Diseases at Duke University Medical Center. 

 

The article is free, informative, and much worth reading in its entirety.

 

Iatrogenic Fungal Meningitis: Tragedy Repeated

John R. Perfect, MD

Ann Intern Med. 18 October 2012

Recent reports of fungal meningitis cases caused by contaminated corticosteroid injections demand that we remember prior lessons learned, while scrambling to care for currently affected persons even before all the facts are in hand.

 

In 2002, the Centers for Disease Control and Prevention (CDC) detailed 5 cases of Exophiala (Wangiella) dermatitidis meningitis or arthritis related to contaminated, injectable, preservative-free methylprednisolone acetate prepared from a compounding pharmacy (1).

(Continue . . .)

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FDA: Exserohilum Found In Unopened Vials Of NECC Methylprednisolone

 

 

# 6645

 

An update this afternoon (h/t Catbird on FluTrackers) from the FDA indicating that tests have confirmed the presence of Exserohilum rostratum in unopened vials of methylprednisolone acetate prepared by the New England Compounding Center (NECC).

 

Update on Fungal Meningitis

• Archive of Updates on Fungal Meningitis Outbreak
• NECC press release and a complete list of the firm's compounded products
• FDA’s Drug Information Line: 855-543-DRUG (3784); email: druginfo@fda.hhs.gov

[10-18-2012] CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratumin unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from one of the three implicated lots from NECC (Lot #08102012@51, BUD 2/6/2013).  The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections.  Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues.

 

CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone and nearly 97% of these patients have been contacted for further follow-up.

 

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

 

Health care professionals and patients may dial FDA’s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the meningitis recall and speak directly to a pharmacist.

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CDC Fungal Meningitis Update – Oct 18th

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The CDC has posted their latest update on the multistate fungal meningitis outbreak, citing ten new cases and one fatality since yesterday. New York is the latest addition to the list of states reporting cases.

*254 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus 3 peripheral joint infections (e.g., knee, hip, shoulder, elbow). No deaths have been associated with peripheral joint infections.

 

 

For detailed clinical findings of one of the index cases, published yesterday in the Annals of Internal Medicine, see :

 

Detailed Report On Fatal Meningitis Case

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Detailed Report On Fatal Meningitis Case

 

Exserohilum rostratum – Credit CDC

 

# 6643

 

 

The journal Annals of Internal Medicine has published a letter describing the findings of one of first index cases of fatal meningitis linked to an epidural injection with a contaminated steroid product.

 

Fatal Exserohilum Meningitis and Central Nervous System Vasculitis after Cervical Epidural Methylprednisolone Injection

Jennifer L. Lyons, MD; Elakkat D. Gireesh, MD; Julie B. Trivedi, MD; W. Robert Bell, MD; Deanna Cettomai, MD; Bryan R. Smith, MD; Sarah Karram, MD; Tiffany Chang, MD; Laura Tochen, MD; Sean X. Zhang, MD, PhD; Chad M. McCall, MD, PhD; David T. Pearce, BS; Karen C. Carroll, MD; Li Chen, MD, PhD; John R. Ratchford, MD, MSc; Daniel M. Harrison, MD; Lyle W. Ostrow, MD, PhD; and Robert D. Stevens, MD

 

 

Those who would like to wade through the detailed clinical findings can use the link above, but briefly: The  patient was a 51 year old woman who presented at the local emergency room with a severe headache on August 31st, 2012 a week after receiving an epidural cervical injection at a pain clinic. 

 

This was before the nationwide alert had gone out about contaminated steroids and fungal meningitis, and so the ER doctors had no reason to suspect that as a cause.

 

 

Since headaches are common after a spinal injection, the ER did a CT scan, assured themselves that she wasn’t having a stroke, and sent her home. But the next day she returned, and her symptoms now resembled meningitis (headache, double vision, dizziness, nausea), and so they admitted her. 

 

Her condition steadily worsened over the next several days while her doctors desperately worked to solve a medical mystery.

 

They tested her spinal fluid for herpes simplex virus, varicella zoster virus, Epstein–Barr virus, cytomegalovirus, and West Nile virus. Antigen tests for cryptococcal and histoplasma antigens along with bacterial cultures of her cerebral-spinal fluid were negative as well.

 

After 8 days - despite trying acyclovir, cefepime, vancomycin, doxycycline, and (a bit ironically) methylprednisolone - her condition had grown increasingly grim, as described below:

 

On day 9, neurologic examination progressed to absent pupillary, corneal, and gag reflexes, and liposomal amphotericin B was added empirically.

 

On day 10, all brainstem reflexes were lost, and death from neurologic criteria was pronounced.

 

Exserohilum species was reported in the cerebrospinal fluid the same day.

Autopsy revealed a grossly necrotic brainstem, and microscopic examination showed angioinvasive, septate fungal hyphae associated with diffuse vasculitis (Figure, H) and hemorrhagic infarction in the brain and spinal cord.

 

In simplest terms, this fungus infected and destroyed her brainstem. The rapid progression of this infection points out how important early diagnosis and treatment will be for those infected.

 

Maggie Fox of NBC News has more on this story, which you can access at:

 

First case history shows fungal meningitis can destroy brain fast

By Maggie Fox, NBC News

She had a history of pain, the 51-year-old woman who showed up at the emergency room with a headache so bad it made her face hurt. Within 10 days she was dead, one of the first victims of an outbreak of fungal meningitis that has killed 19 people and made more than 240 sick.

 

(Continue . . )

 

 

According to the New York Times yesterday, doctors are debating the merits of starting prophylactic treatment in asymptomatic patients.

So far, the advice has been strongly against it, primarily because of the potential for antifungal drugs to cause liver, heart, and kidney damage. 

 

This from the CDC’s Clinical Guidance:

 

Interim Guidance for Management of Asymptomatic Persons Exposed to Potentially Contaminated Steroid Products

October 14, 2012 4:30 PM EDT

Antifungal prophylaxis for patients who received epidural injections with potentially contaminated steroid products

• At this time, CDC does not recommend initiation of antifungal prophylaxis in exposed patients who are asymptomatic. These patients should be closely monitored for development of symptoms, with a low threshold for performing lumbar puncture should the patient become symptomatic. When diagnostic lumbar punctures are performed, they should be done through a site other than the site used for epidural injection when possible.

 

Another concern is since treatment courses could go on for months - with thousands of people exposed - the supply of anti-fungal drugs may not be sufficient to treat asymptomatic cases.

 

We should get an update later this afternoon on the case counts from the CDC, and perhaps some new guidance. 

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CDC Fungal Meningitis Update – Oct 17th

# 6640

 

The CDC updated their case counts for the multistate steroid-injection-related fungal meningitis outbreak this afternoon, showing 14 new cases diagnosed and 4 additional deaths.

 

 

*245 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus 2 peripheral joint infections (e.g., knee, hip, shoulder, elbow). No deaths have been associated with peripheral joint infections.

 

 

While there aren’t any new clinical or patient guidance docs posted on the CDC site today, we are seeing press announcements coming from individual State Health Departments around the nation, including:

 

Florida

FOR IMMEDIATE RELEASE      October 17, 2012          

FLORIDA CONFIRMS THIRD DEATH IN MENINGITIS OUTBREAK

TALLAHASSEE – The Florida Department of Health (DOH) has confirmed a third death as a result of the fungal meningitis outbreak associated with contaminated steroids.  

Idaho

Health officials contact Idaho clinics about possible infections related to expanded meningitis investigation

 

posted on October 16, 2012 16:47

The Idaho Division of Public Health is contacting nine Idaho medical facilities that may have received injectable drugs from New England Compounding Center (NECC) since May 2012 that could pose a potential risk for infection or meningitis. The nine clinics are being urged to contact their patients who may have received injections to make certain they do not have symptoms of infection and to report any new symptoms.

Massachusetts

For Immediate release - October 16, 2012

Statement of Dr. Madeleine Biondolillo, Director of the Bureau for Health Care Safety and Quality at the Massachusetts Department of Public Health on October 15, 2012 regarding the ongoing NECC investigation

“As part of our comprehensive response, DPH secured a recall of all NECC products and a surrender of the company’s license to operate immediately following the outbreak. We worked with our partners in the FDA and CDC to promptly notify all providers that they should isolate and remove all NECC products from their supply. Today FDA advised out of an abundance of caution that patients who have received any injectable products from NECC should be notified of the potential risk of infection. DPH is working to promptly conduct notifications with providers in Massachusetts now. The FDA has not confirmed that additional meningitis cases are connected to other NECC products at this point, and the investigation is ongoing. There are no known cases of fungal meningitis in the Commonwealth.”

Minnesota

Health officials contacting clinics in state to urge them to contact patients who received other NECC drugs possibly associated with fungal infections

129 clinics received the products

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CDC/FDA: Multistate Fungal Meningitis Outbreak – Oct 15th

 

# 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.

(Continue . . . )

 

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.

(Continue . . . )

 

 

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:

 

NEW: COCA Conference Call - Multistate Fungal Meningitis Outbreak Investigation Update: Information and Guidance for Clinicians - October 16, 2012
 

 

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

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