US - CDC reports 63 dead, 749 infected with fungal meningitis in 20 states (Update Aug 5, 2013)

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Re: 7 dead, 64 sick from suspected fungal meningitis as outbreak worsens

Ohio Department of Health

FOR IMMEDIATE RELEASE October 6, 2012
Contact: Office of Public Affairs 614.644.8562

TAINTED STEROID INJECTIONS SUSPECTED BEHIND OHIO CASE OF FUNGAL MENINGITIS

State Health Department Conducting Widespread Outreach to Facilitate Drug Recall & Encourage Physicians to Look Out for Symptoms

COLUMBUS ? The Ohio Department of Health (ODH) today announced that a case of fungal meningitis in a 65-year-old man was likely caused by a tainted epidural steroid injection from New England Compounding Center in Framingham, Mass. This disease is not communicable and cannot be spread person to person. A county of residence is not being released to protect the man?s identity.

After the federal Centers for Disease Control and Prevention (CDC) notified ODH that tainted medication from the Mass. drug maker went to four Ohio healthcare facilities, state health officials have worked closely with the clinics, local health officials and the CDC to contact patients who may have received tainted medicine. The four clinics are Marion Pain Clinic and BKC Pain Specialists in Marion, Cincinnati Pain Management and Ortho-Spine Rehab Center in Dublin.

Late Friday evening the federal Food and Drug Administration (FDA) expanded the recall to include other drugs from the company. Though the drugs included in the expanded recall have not been linked to any illnesses, out of an abundance of caution ODH notified physicians in Ohio to be on the lookout for the subtle symptoms of fungal meningitis.

More...

http://www.odh.ohio.gov/~/media/ODH/ASSETS/Files/news/Recall%20Expanded-%20One%20Ohio%20Case%2010%206%2012.ashx

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Re: 7 dead, 64 sick from suspected fungal meningitis as outbreak worsens

Updated: 11:43 a.m. Sunday, Oct. 7, 2012 | Posted: 11:43 a.m. Sunday, Oct. 7, 2012

Ind. reports 8 meningitis cases tied to steroid

The Associated Press
INDIANAPOLIS ?

A state health official says Indiana now has eight cases of fungal meningitis linked to a tainted back pain medication, up from Saturday's five reported cases.

State Department of Health spokesman Ken Severson also said in a Sunday morning statement that there have been no deaths in Indiana associated with the outbreak...

http://www.whiotv.com/news/ap/health/ind-reports-8-meningitis-cases-tied-to-steroid/nSW6M/

[Pathfinder]

Re: 7 dead, 64 sick from suspected fungal meningitis as outbreak worsens

Scant Oversight of Drug Maker in Fatal Meningitis Outbreak

By DENISE GRADY, ANDREW POLLACK and SABRINA TAVERNISE

Published: October 6, 2012

Eddie C. Lovelace, a Kentucky judge still on the bench into his late 70s, had a penchant for reciting Shakespeare from memory and telling funny stories in his big, booming voice. But a car accident last spring left him with severe neck pain, and in July and August he sought spinal injections with a steroid medicine for relief.

Instead, Judge Lovelace died in Nashville in September at age 78, one of the first victims in a growing national outbreak of meningitis caused by the very medicine that was supposed to help him. Health officials say they believe it was contaminated with a fungus.

The rising toll ... has cast a harsh light on the loose regulations that legal experts say allowed a company to sell 17,676 vials of an unsafe drug to pain clinics in 23 states.

?This wasn?t some obscure procedure being done in some obscure hospital,? said Tom Carroll, a close friend to the Lovelace family, and their lawyer. ?They had sought out a respected neurosurgeon who had been referred by their family doctor, at a respected hospital,? he said, referring to the St. Thomas Outpatient Neurosurgery Center. ?How does this happen??

The answer, at least in part, is that some doctors and clinics have turned away from major drug manufacturers and have taken their business to so-called compounding pharmacies, like New England Compounding, which mix up batches of drugs on their own, often for much lower prices than major manufacturers charge ? and with little of the federal oversight of drug safety and quality that is routine for the big companies.
...
Some physicians who work in big hospitals may not even know whether the drug they use is from a compounder.

Dr. Anders Cohen, the chief of neurosurgery and spine surgery at the Brooklyn Hospital Center, said: ?We ask for the medication, it?s in stock, we use it. I don?t know if it?s coming from A, B or C. This is kind of a wake-up call about where your stuff is coming from.?
...
Full text:

http://www.nytimes.com/2012/10/07/us/scant-drug-maker-oversight-in-meningitis-outbreak.html?pagewanted=all&_r=0

[Catbird]

Re: 7 dead, 64 sick from suspected fungal meningitis as outbreak worsens

Various media are reporting that CDC will be doing an update briefing at 2pm EST today, about an hour from now.

[mixin]

Re: 7 dead, 64 sick from suspected fungal meningitis as outbreak worsens

Now, a 2nd type of fungus has been found:

Published Date: 2012-10-07 12:01:52
Subject: PRO/EDR> Aspergillus meningitis - USA (04): more cases, 2nd fungus
Archive Number: 20121007.1328893
ASPERGILLUS MENINGITIS - USA (04): MORE CASES, SECOND FUNGUS
************************************************** **********
A ProMED-mail post

http://www.promedmail.org

ProMED-mail is a program of the
International Society for Infectious Diseases

http://www.isid.org

Date: Sat 6 Oct 2012

Source: NBC News [edited]

http://vitals.nbcnews.com/_news/2012/10/05/14245074-seven-deaths-reported-in-growing-meningitis-outbreak-second-fungus-found?chromedomain=dailynightly&lite

Federal health officials have widened their recall of drugs suspected of giving people an unusual type of meningitis that has, so far, killed 7, and identified 2 different types of fungus they believe are infecting people. At least 64 cases in 9 states have been diagnosed with meningitis linked to the contaminated drugs, the CDC reported Sat 6 Oct 2012. Health experts expect more cases will be reported and are asking anyone who had a recent steroid injection for lower back pain to be on the lookout for headaches, stiff neck, unsteadiness, and other classic symptoms of meningitis.
...
"Fungus has been identified in specimens obtained from 9 patients, including _Aspergillus_ and _Exserohilum_," CDC said. Both types of fungus are found in back yards; _Exserohilum_ can cause leaf spot, but it has also been linked to skin and sinus infections. _Aspergillus_ causes lung infections in cancer, HIV, and other patients with suppressed immune systems. Some kind of fungal contaminant has been found in at least one vial of drugs made by the pharmacy. Fungi can grow in drugs that are not stored properly, especially those without preservatives, like those made by the compounding pharmacy.
...
The FDA says there will be no shortage of methylprednisone. "There are FDA approved versions of methylprednisolone acetate injection on the market, available with or without preservatives," it said.
...
"Although all cases detected to date occurred after injections with products from these 3 lots, out of an abundance of caution, CDC and FDA recommend that healthcare professionals cease use of any product produced by the New England Compounding Center until further information is available," the FDA added. Among the other drugs from the pharmacy being recalled are 3 steroid drugs, betamethasone, a steroid usually given in creams or as a spray, dexamethasone and triamcinolone; 2 local anesthetics called lidocaine and bupivicaine; the blood pressure drug clonidine; and saline.

http://www.promedmail.org/direct.php?id=20121007.1328893

[mixin]

Re: 7 dead, 64 sick from suspected fungal meningitis as outbreak worsens

From an earlier ProMED article:

[snip]
The New England company is what is known as a compounding pharmacy. These pharmacies custom-mix solutions, creams, and other medications in doses or in forms that generally aren't commercially available. Other compounding pharmacies have been blamed in recent years for serious and sometimes deadly outbreaks caused by contaminated medicines. Compounding pharmacies are not regulated as closely as drug manufacturers, and their products are not subject to FDA approval.

A national shortage of many drugs has forced doctors to seek custom-made alternatives from compounding pharmacies. The New England company at the center of the outbreak makes dozens of other medical products, state officials said. But neither the company nor health officials would identify them.

http://www.promedmail.org/direct.php?id=20121005.1326188

My question would be: Why are these medical professionals using drugs from loosely regulated pharmas when FDA approved versions are available?

[Treyfish]

Re: 7 dead, 64 sick from suspected fungal meningitis as outbreak worsens

U.S. CDC to give update on deadly meningitis outbreak Sunday

Oct 7 (Reuters) - The latest tally of cases in a widening outbreak of fungal meningitis linked to steroid injections will be made available at 2 p.m. EDT (1800 GMT) on Sunday, the Centers for Disease Control and Prevention said...As of Saturday, the death toll had risen to seven and 65 people in nine states were reported to have fallen ill after receiving steroid injections. The cases have been traced to three lots of the steroid prepared by a pharmaceutical compounding plant in Massachusetts, New England Compounding Center Inc.

The CDC, which advised of the pending update on its website, said vials of steroids linked to the outbreak were shipped to 76 facilities in 23 states and could have been used to inject thousands of patients.

So far, cases of people becoming ill after receiving the steroid injections have been reported in Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Tennessee and Virginia.

Deaths have been reported in Tennessee, Maryland, Michigan and Virginia.

Meningitis is an infection of the membranes covering the brain and spinal cord. The particular form affecting people in the outbreak is not contagious.

http://www.reuters.com/article/2012/...8L71H420121007

[Pathfinder]

Re: 7 dead, 64 sick from suspected fungal meningitis as outbreak worsens

<TABLE border=0 cellPadding=0 width="95%"><TBODY><TR><TD align=center>New England Compounding Center Issues
Voluntary Nationwide Recall of All Products




</TD></TR><TR><TD align=left>
October 6, 2012


New England Compounding Pharmacy, Inc. d/b/a New England Compounding Center (NECC) today announced a recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts. This action is being taken out of an abundance of caution due to the potential risk of contamination, and in cooperation with an investigation being conducted by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Massachusetts Board of Registration in Pharmacy. The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained and secured.

While there is no indication at this time of any contamination in other NECC products, this recall is being taken as a precautionary measure. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), and/or the company logo that can be accessed here. A complete list of all products subject to this recall can be accessed here.

NECC is notifying its customers of this recall by fax. Clinics, hospitals and healthcare providers that have product which is being recalled should stop using the product immediately, retain and secure the product, and follow instructions contained in the fax notice.

Adverse reactions or quality problems experienced with the use of any product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
? Online: www.fda.gov/medwatch/report.htm
? Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
? Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.



</TD></TR></TBODY></TABLE>http://www.neccrx.com/

[Treyfish]

Re: 7 dead, 64 sick from suspected fungal meningitis as outbreak worsens

CDC: More than 90 people ill with meningitis
Updated: Sunday, 07 Oct 2012, 1:33 PM CDT
Published : Sunday, 07 Oct 2012, 1:33 PM CDT

ATLANTA (AP) ? Health officials say they have now confirmed more than 90 cases of a rare fungal meningitis that has been linked to a steroid commonly used to ease back pain.

The Centers for Disease Control and Prevention posted updated figures to its website Sunday. The death toll stood at 7, the same number as a day earlier. The outbreak is spread across nine states, the same states reported Saturday: Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Tennessee and Virginia.

The CDC figures show there are 91 cases in the U.S. altogether.

The steroid linked to the outbreak has been recalled, and health officials have been scrambling to notify anyone who may have received an injection of it. The Massachusetts pharmacy that made it has said it is cooperating with investigators.http://www.fox10tv.com/dpp/news/nati...gitis_39905146

[Pathfinder]

Re: 7 dead, 64 sick from suspected fungal meningitis as outbreak worsens

Multi-State Meningitis Outbreak - Current Case Count

October 7, 2012 2:00 PM EDT
Persons with Meningitis Linked to Epidural Steroid Injections, by State

<!--See larger map
-->
Persons with meningitis linked to epidural steroid injections, as of October 7, 2012:
Total case count: 91
Florida: 4 cases
Indiana: 8 cases
Maryland: 3 cases, including 1 death
Michigan: 20 cases, including 2 deaths
Minnesota: 3 case
North Carolina: 2 cases
Ohio: 1 case
Tennessee: 32 cases, including 3 deaths
Virginia: 18 cases, including 1 death

http://www.cdc.gov/hai/outbreaks/meningitis-map.html

[Treyfish]

Re: 7 dead, 64 sick from suspected fungal meningitis as outbreak worsens

At-A-Glance
Status: Ongoing Investigation
Infection:
Fungal Meningitis
Facility Type:
Outpatient Setting
Case Count: 91
States: 9
Deaths: 7

http://www.cdc.gov/HAI/outbreaks/meningitis.html

[Treyfish]

Re: 7 dead, 91 sick from suspected fungal meningitis as outbreak worsens

2:48 p.m. Sunday, Oct. 7, 2012 | Posted: 2:48 p.m. Sunday, Oct. 7, 2012
Meningitis outbreak sparks call for FDA action

HARTFORD, Conn. ? U.S. Sen. Richard Blumenthal is calling for stronger government oversight of so-called "compounding pharmacies" amid a meningitis outbreak in several states that has killed seven people.
The Connecticut Democrat said Sunday that he will be writing to U.S. Food and Drug Administration Commissioner Margaret Hamburg to ask for stricter scrutiny of such pharmacies. He said the facilities appear to operate in a "regulatory black hole" and are only marginally overseen by the FDA.
Federal officials have linked the outbreak to a steroid for back pain produced by the New England Compounding Center in Framingham, Mass. Ninety-one people in nine states have contracted fungal meningitis. There are no cases in Connecticut.
Blumenthal says he will be proposing more authority for the FDA in such cases, if needed.http://www.ajc.com/news/ap/health/me...action/nSW8y/?

[sharon sanders]

Re: 7 dead, 91 sick from suspected fungal meningitis as outbreak worsens

Interim Treatment Guidance for Central Nervous System and/or Parameningeal Infections Associated with Injection of Potentially Contaminated Steroid Products

October 6, 2012 4:00pm ET

The pathogens involved in this cluster of infections are still under investigation. At present, there is culture and/or histopathologic evidence of fungal infection in at least nine patients; isolates have included Aspergillus spp. and Exserohilum spp. At least one patient also had Propionibacterium acnes of unclear clinical significance isolated from a post-mortem central nervous system (CNS) specimen. When initiating treatment for patients with meningitis (i.e., cerebrospinal fluid [CSF] pleocytosis regardless of glucose and protein levels), epidural abscess, and/or vertebral osteomyelitis of unknown etiology who are linked to the cluster, clinicians should continue to follow routine empiric treatment protocols to cover for potential bacterial pathogens and add empiric broad-spectrum antifungal therapy to the treatment regimen because of the severe adverse outcomes of untreated invasive fungal infection. These recommendations are based upon current evidence that at least two fungal pathogens are involved, and the possibility that additional pathogens may be identified as the investigation continues. CDC has consulted with national experts on treatment options for fungal CNS and/or parameningeal infections in patients associated with this cluster. The following represents interim guidance and may change as new information becomes available.

• Consult an infectious disease physician to assist with diagnosis, management, and follow–up which may be complex and prolonged.

• After collecting cerebrospinal fluid for culture, initiate empiric combination antifungal therapy using the following regimen in addition to routine empiric treatment protocols to cover for potential bacterial pathogens until the etiology of the patient’s CNS and/or parameningeal infection has been identified:

• • Voriconazole, preferably at a dose of 6mg/kg every 12 hours (IV initially) and to continue on this high dose for the duration of treatment, if possible. Regular monitoring of serum concentration is advisable.
    
    AND
  
  

• • Liposomal Amphotericin B (preferred over other lipid formulations), preferably at a dose of 7.5 mg/kg IV daily (higher than standard dose). If nephrotoxicity is a potential concern, particularly in older patients, the dose may be decreased to 5mg/kg IV daily. Administration of 1L normal saline prior to infusion may be considered to minimize risk of nephrotoxicity.
  
  

• • Avoid routine use of intrathecal amphotericin B, either the deoxycholate or the lipid formulations, due to limited data on its use and associated toxicities.
  
  

• Adequate duration of treatment is unknown but likely will require prolonged antifungal therapy (e.g., months) tailored by the clinical response to infection. Individual management decisions, including choice of long-term antifungal regimen, should be made in consultation with infectious disease physicians experienced in the treatment of fungal infections. Clinicians should be vigilant for potential relapse of infection after completion of therapy.

• At this time, CDC does not recommend initiation of antifungal prophylaxis in exposed patients who are asymptomatic and/or have normal CSF laboratory examination. These patients should be closely monitored for development of symptoms, with a low threshold for performing lumbar puncture should the patient become symptomatic.

• There is currently no clear evidence for the use of adjuvant steroid therapy. If used, careful monitoring of clinical status is warranted.

Contact Us:

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• Page last reviewed: October 6, 2012 4:00pm ET
• Page last updated: October 6, 2012 4:00pm ET
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  National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
  Division of Healthcare Quality Promotion (DHQP)

http://www.cdc.gov/hai/outbreaks/clinicians/guidance_cns.html

[sharon sanders]

Re: 7 dead, 91 sick from suspected fungal meningitis as outbreak worsens

Lumbar Puncture in Asymptomatic Patients

October 6, 2012 4:00pm ET
At this time, CDC does not recommend performing lumbar puncture in exposed patients who are currently asymptomatic. These patients should be closely monitored for development of symptoms, with a low threshold for performing lumbar puncture should the patient become symptomatic. The clinical investigation of patients associated with this cluster is ongoing, and this recommendation may change as new information becomes available


Contact Us:

• Centers for Disease Control and Prevention
  1600 Clifton Rd
  Atlanta, GA 30333
• 800-CDC-INFO
  (800-232-4636)
  TTY: (888) 232-6348
• New Hours of Operation
  8am-8pm ET/Monday-Friday
  Closed Holidays
• cdcinfo@cdc.gov

• Page last reviewed: October 6, 2012 4:00pm ET
• Page last updated: October 6, 2012 4:00pm ET
• Content source: Centers for Disease Control and Prevention
  National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
  Division of Healthcare Quality Promotion (DHQP)

http://www.cdc.gov/hai/outbreaks/clinicians/guidance_lumbar_puncture.html

[sharon sanders]

Re: 7 dead, 91 sick from suspected fungal meningitis as outbreak worsens

Role of Antifungal Prophylaxis in Asymptomatic Patients

October 6, 2012 4:00pm ET


At this time, CDC does not recommend initiation of antifungal prophylaxis in exposed patients who are asymptomatic and/or have normal cerebrospinal fluid laboratory examination. These patients should be closely monitored for development of symptoms, with a low threshold for performing lumbar puncture should the patient become symptomatic.


Contact Us:

• Centers for Disease Control and Prevention
  1600 Clifton Rd
  Atlanta, GA 30333
• 800-CDC-INFO
  (800-232-4636)
  TTY: (888) 232-6348
• New Hours of Operation
  8am-8pm ET/Monday-Friday
  Closed Holidays
• cdcinfo@cdc.gov

• Page last reviewed: October 6, 2012 4:00pm ET
• Page last updated: October 6, 2012 4:00pm ET
• Content source: Centers for Disease Control and Prevention
  National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
  Division of Healthcare Quality Promotion (DHQP)

http://www.cdc.gov/hai/outbreaks/clinicians/gudance_antifungal_prophylaxis.html