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

Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

cartski said:
Canada assigns a unique identifier to each drug: "drug identification number" or DIN.

With that unique key, insurers of any type can search "backwards": look at each payment transaction for that DIN to identify the cohort of purchasors, and perhaps the patient, Dr., and pharmacy

Drs. can find out what drugs a patient has taken, but that's a "forward" analysis: going from the individual to gain the set of drugs taken by that person.

The FDA list doesn't have any such number, just the generic name of the drug. Aside from the fact that numerous manufacturers make the same product, matching databases is next to impossible without the unique key.

So another angle is to ask if any of the NECC products were in the country in the first place.

J.
Click to expand...


I do not see Health Canada listed as a customer but the FDA says this is the list given to them by NECC so.......
 
Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

I've also tried to do some digging on this question and I'm not finding anything about exports. But it's pretty complicated as there are actually at least 3 other companies that are interconnected with NECC. They are Ameridose LLC, Alaunus Pharmacy, and Medical Sales Management. The last 2 companies seem to handle the management, marketing and distribution of products made by Ameridose and NECC.

I suspect that if there is an export license, it would be under the name of either Alaunus or Medical Sales Management. The website for Alaunus (here) does not mention anything about international business:

"Company Profile

Based in Framingham, Massachusetts, privately held Alaunus Pharmaceutical is an emerging pharmaceutical company that identifies, develops, and markets generic pharmaceutical products to physicians and pharmacies throughout the United States."
Click to expand...

A good article that gives a pretty thorough background on the companies and their owners can be found at Pharmaceutical Intelligence.
 
Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

The CDC update for Oct. 22nd (NOTE: As of 4:30 pm, there are no updates to the Current Situation, case definitions, or patient and clinician guidance.):


  • Status: Ongoing Investigation
  • Infection: Fungal
  • Facility Type: Outpatient Setting
  • Case Count: 297
  • States: 16
  • Deaths: 23
 
Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

UPDATE 1-Meningitis probe could hit hospital drug supplies - FDA

Mon Oct 22, 2012 3:54pm EDT
By Bill Berkrot

Oct 22 (Reuters) - The extended shutdown of a sister company of the pharmacy at the center of the deadly U.S. meningitis outbreak may exacerbate drug shortages for some hospitals and healthcare providers as the number of infection cases neared 300, U.S. health regulators said.

Ameridose, a drug manufacturer owned by the same people who own New England Compounding Center (NECC), has been closed since Oct. 10 and will remain shuttered until Nov. 5, while authorities complete an inspection of the plant as a precautionary measure - at least temporarily cutting off supplies to its customers.

NECC shipped thousands of potentially contaminated vials of a steroid used for injections to treat severe back pain. Some 14,000 patients may have been exposed to the medici:tiphat:http://www.reuters.com/article/2012...gitis-shortages-idUSL1E8LMK7N20121022?rpc=401
 
Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

I happened to come across this notice while looking for further information on Ameridose, etc. This notice is dated Oct. 12th and obviously only applies to Baptist Health System hospitals but this may be an issue elsewhere as well.



Baptist Health System:
ATTN: DRUG SHORTAGE - OXYTOCIN


Ameridose and Alaunus Pharmaceutical are temporarily ceasing distribution of all products. This impacts our supply of some narcotics and Oxytocin. This situation has created an immediate shortage of Oxytocin. We are aggressively working to obtain additional supplies from other channels through our pharmacy vendors.

ACTION REQUIRED: Please make every effort to conserve in a clinically-appropriate manner the use of Oxytocin. We are asking that use of L R 1000 mL with 20 units Oxytocin be used sparingly. We will keep you posted as new information is available on this situation...
Click to expand...
 
Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

sharon sanders said:
I do not see Health Canada listed as a customer but the FDA says this is the list given to them by NECC so.......
Click to expand...

Health Canada is the equivalent to the FDA or CDC. It is a regulatory body, not a purchasor, distributor, or importer. The importers are likely other pharm companies of one sort or another, perhaps with the same names as the US parent co., but with a Canadian address.

There's potential for myopia in terms of the company person supplying the information to the requestor. If the latter is a US agency, it may be seen as unnecessary to disclose exports because the US agency has no jurisdiction over experts. Pehaps....this is conjecture. I really don't know anything abotu the export rules, or the problem of product dumping.

J.
 
Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

Re: US - 23 dead, 285 sick from suspected fungal meningitis as outbreak worsens

The FDA has pulled the lists of states and facilities that have received shipments of drugs from NECC since May 21, 2012. The FDA statement has been posted at http://www.flutrackers.com/forum/showthread.php?t=194131


CNN:

"...On Monday, the Food and Drug Administration posted on its website a list of more than 1,200 hospitals and clinics that had purchased steroids and other drugs from NECC that if contaminated would be especially dangerous for patients.

The agency then took the list down after it realized it wasn't accurate.

"FDA has found some technical problems with the list and the data are incorrect," according to a statement on the agency's website. "FDA is working to correct the list and will re-post when we are sure it is accurate.""
 
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Re: US - 23 dead, 308 sick from suspected fungal meningitis in 17 states

Re: US - 23 dead, 308 sick from suspected fungal meningitis in 17 states

The CDC has updated its' Current Situation page (see below) and Patient Guidance (see updated thread here).

What Should Patients Do?

Frequently Asked Questions for Patients: Multistate Fungal Meningitis Outbreak Investigation




Multistate Fungal Meningitis Outbreak Investigation

Current Situation

October 23, 2012 12:30 PM EDT

CDC Responds to Multistate Fungal Meningitis Outbreak

The Centers for Disease Control and Prevention (CDC), in collaboration with state and local health departments and the Food and Drug Administration (FDA), is investigating a multistate fungal meningitis outbreak among patients who received contaminated steroid injections. Several patients suffered strokes that are believed to have resulted from their infections. The investigation also includes fungal infections associated with injections in a peripheral joint, such as a knee, shoulder or ankle.

CDC and public health officials are referring any patients who have symptoms that suggest possible fungal infection to their physicians, who can evaluate them further. Patients who received injections in peripheral joints only are not believed to be at risk for meningitis, but they could be at risk for joint infection.


About the Investigation

  • CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in 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 injectable medications continues.
  • As of October 17, 2012, a total of 47 patients have laboratory-confirmed fungal meningitis. This form of fungal meningitis is not contagious. CDC?s laboratory has confirmed Exserohilum rostratum in clinical specimens for all but two patients of these patients. Of the other two patients, one has been found to be infected with Aspergillus fumigatus and one with Cladosporium. These fungi are common in the environment but rarely cause meningitis.
  • CDC continues to work with states to determine if there may be other fungal infections caused by exposure to NECC products beyond the three lots of preservative-free methylprednisolone acetate (80mg/ml) from NECC that were recalled on September 26, 2012. CDC does not have firm evidence that fungal infections have been caused by exposure to other NECC products.
  • CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from the three implicated lots of methylprednisolone and nearly 97% have now been contacted for further follow-up.
  • 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.
  • Information about the investigation and guidance for clinicians, including interim treatment guidelines, is available at http://www.cdc.gov/hai/outbreaks/meningitis.html. CDC recommendations are subject to change as more information becomes available.
 
Re: US - 23 dead, 308 sick from suspected fungal meningitis in 17 states

Re: US - 23 dead, 308 sick from suspected fungal meningitis in 17 states

CDC updates, as of 2:30 pm, Oct. 24th:

  • Status: Ongoing Investigation
  • Infection: Fungal
  • Facility Type: Outpatient Setting
  • Case Count: 317
  • States: 17
  • Deaths: 24


NEW: Health Alert Network (HAN) - Oct 23, 2012 (See thread here.)


UPDATE: Interim Treatment Guidance for Central Nervous System (CNS) and Parameningeal Infections Associated with Injection of Contaminated Steroid Products (See thread here.)

UPDATE: Frequently Asked Questions for Patients: Multistate Fungal Meningitis Outbreak Investigation (See thread here.)


The following updates can be found on this thread.

UPDATE: Interim Treatment Guidance for Osteoarticular Infections Associated With Injection of Contaminated Steroid Products

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

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

UPDATE: Frequently Asked Questions for Clinicians: Multistate Fungal Meningitis Outbreak Investigation



Multistate Fungal Meningitis Outbreak Investigation​
Current Situation​

October 24, 2012 12:00 PM EDT

CDC Responds to Multistate Fungal Meningitis Outbreak

The Centers for Disease Control and Prevention (CDC), in collaboration with state and local health departments and the Food and Drug Administration (FDA), is investigating a multistate fungal meningitis outbreak among patients who received contaminated steroid injections. Several patients suffered strokes that are believed to have resulted from their infections. The investigation also includes fungal infections associated with injections in a peripheral joint, such as a knee, shoulder or ankle.

CDC and public health officials are referring any patients who have symptoms that suggest possible fungal infection to their physicians, who can evaluate them further. Patients who received injections in peripheral joints only are not believed to be at risk for meningitis, but they could be at risk for joint infection.


About the Investigation

  • CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from two of the three implicated lots from NECC (Lot #06292012@26, BUD12/26/2012). 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 third implicated lot of methylprednisolone acetate and other NECC injectable medications continues.
  • As of October 22, 2012, a total of 54 patients have CDC laboratory-confirmed fungal meningitis. This form of fungal meningitis is not contagious. CDC?s laboratory has confirmed Exserohilum rostratum in clinical specimens for all but two patients of these patients. Of the other two patients, one has been found to be infected with Aspergillus fumigatus and one with Cladosporium. These fungi are common in the environment but were not a recognized cause of meningitis prior to this outbreak.
  • CDC continues to work with states to determine if there may be other fungal infections caused by exposure to NECC products beyond the three lots of preservative-free methylprednisolone acetate (80mg/ml) from NECC that were recalled on September 26, 2012. CDC does not have firm evidence that fungal infections have been caused by exposure to other NECC products.
  • CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from the three implicated lots of methylprednisolone and nearly 97% have now been contacted for further follow-up.
  • 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.
  • Information about the investigation and guidance for clinicians, including interim treatment guidelines, is available at http://www.cdc.gov/hai/outbreaks/meningitis.html. CDC recommendations are subject to change as more information becomes available.
 
Re: US - 24 dead, 317 sick from suspected fungal meningitis in 17 states

Re: US - 24 dead, 317 sick from suspected fungal meningitis in 17 states

Source: http://www.wibw.com/home/nationalne...is-Outbreak-Claims-24th-Victim-175692841.html


Posted: Wed 5:53 PM, Oct 24, 2012
Reporter: CBS News, Posted by Chelsey Moran
Fungal Meningitis Outbreak Claims 24th Victim

A twenty-fourth person has died of fungal meningitis, the Centers for Disease Control and Prevention reported Wednesday. An Indiana resident died from the outbreak tied to contaminated steroid injections from the New England Compounding Center.

As of Oct. 24, there are 317 reported infections tied to the outbreak in 17 states. The previous day there had been 308 infections including 23 deaths...
 
Re: US - 24 dead, 317 sick from suspected fungal meningitis in 17 states

Re: US - 24 dead, 317 sick from suspected fungal meningitis in 17 states

CDC update for Oct. 25th includes new Case Definitions (see thread here). There are no updates to the Current Situation, or to Clinician or Patient Guidance.

  • Status: Ongoing Investigation
  • Infection: Fungal
  • Facility Type: Outpatient Setting
  • Case Count: 328
  • States: 18
  • Deaths: 24
 
Re: US - 24 dead, 328 sick from suspected fungal meningitis in 18 states

Re: US - 24 dead, 328 sick from suspected fungal meningitis in 18 states

CDC update for Oct. 26th shows no changes or additions to the Current Situation, or Clinician or Patient Guidance. There was a COCA Call held yesterday but the transcript has not been posted yet.


Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 338
States: 18
Deaths: 25
 
Re: US - 25 dead, 338 sick from suspected fungal meningitis in 18 states

Re: US - 25 dead, 338 sick from suspected fungal meningitis in 18 states

The CDC update for Oct. 27th does not include any changes to the Current Situation, or Clinician or Patient Guidance.

  • Status: Ongoing Investigation
  • Infection: Fungal
  • Facility Type: Outpatient Setting
  • Case Count: 344
  • States: 18
  • Deaths: 25
 
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Re: US - 25 dead, 344 sick from suspected fungal meningitis in 18 states

Re: US - 25 dead, 344 sick from suspected fungal meningitis in 18 states

The CDC update for Oct. 29th includes the first confirmed case in Rhode Island. As of 2 pm, there are no updates to the Current Situation, or Clinician or Patient Guidance.

  • Status: Ongoing Investigation
  • Infection: Fungal
  • Facility Type: Outpatient Setting
  • Case Count: 354
  • States: 19
  • Deaths: 25
 
Re: US - 28 dead, 363 infected from suspected fungal meningitis in 19 states

Re: US - 28 dead, 363 infected from suspected fungal meningitis in 19 states

3 more deaths bring total to 28.
The article also says total joint infections are 7 and total overall infections are 363.

http://www.reuters.com/article/2012/10/30/us-usa-health-meningitis-deaths-idUSBRE89T1HX20121030
Tue Oct 30, 2012 3:02pm EDT

(Reuters) - Three more patients have died after contracting fungal meningitis from potentially tainted steroid injections supplied by a Massachusetts company, the U.S. Centers for Disease Control and Prevention said on Tuesday, bringing the death toll from the outbreak to 28 nationwide.
Click to expand...

http://www.cdc.gov/hai/outbreaks/meningitis.html
 
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Re: US - 14 dead, 170 sick from suspected fungal meningitis as outbreak worsens

Re: US - 14 dead, 170 sick from suspected fungal meningitis as outbreak worsens

cartski said:
This recall list is huge.

http://www.fda.gov/Safety/Recalls/ucm322979.htm

The opioids on this list are extremely common, especially for workers compensation claimants.

http://www.propertycasualty360.com/2012/10/03/wcri-longer-term-opioid-use-for-workers-comp-claim

"The study, ?Longer-Term Use of Opioids,? conducted by the Workers Compensation Research Institute, finds that longer-term use--defined by WCRI as claimants who were prescribed opioids within the first three months after a non-surgical injury and had three or more visits to fill opioid prescriptions between 7 and 12 months after the injury--increased in 10 of the study states, with the highest year-to-year increases in Arkansas (3 percent increase), Michigan (2 percent) and New York (2 percent). "


Is there an indication about export, or production under contract and branded under another name?

Big insurers also have drug formularies - schedules that dictate which drugs and manufucturers are covered by the insurance program. Are NECC products named in those formularies?

J.
Click to expand...


I know we had a brief discussion of whether NECC or associated companies exported any products.

The article below is the first confirmation, from official or media sources, that no products were directly exported to Canada. I still haven't been able to find anything definitive on the possibility of relabeling/packaging for indirect export.

US meningitis outbreak not affecting Canadians, Health Canada says

"OTTAWA - Health Canada says the meningitis outbreak that has claimed at least 25 lives in the United States is not affecting Canada.

But it says any Canadians who travelled to the U.S. for medical treatment on or after May 21 of this year should check online to see if their treatment facility received products from the New England Compounding Center.

...Health Canada says there have been no cases of fungal meningitis linked to the outbreak reported in Canada, and New England Compounding Center is not licensed to produce health products for the Canadian market."
 
Re: US - 28 dead, 363 infected from suspected fungal meningitis in 19 states

Re: US - 28 dead, 363 infected from suspected fungal meningitis in 19 states

As of 8pm, today's CDC update does not include any changes in the Current Situation, or Clinician or Patient Guidance, nor are there any updates on the FDA website.


  • Status: Ongoing Investigation
  • Infection: Fungal
  • Facility Type: Outpatient Setting
  • Case Count: 363
  • States: 19
  • Deaths: 28
 
Re: US - 28 dead, 363 infected with fungal meningitis in 19 states

Re: US - 28 dead, 363 infected with fungal meningitis in 19 states

Today's update from CDC records a 3rd death in VA. There have been no changes posted for the Current Situation, nor to Clinician or Patient Guidance. At this time, there have been no updates on the FDA website.

Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 377
States: 19
Deaths: 29
 
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