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

[Shiloh]

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

Source: http://www.trust.org/alertnet/news/c...s-toll-now-14/

CDC reports 2 more U.S. meningitis outbreak deaths; toll now 14
Thu, 11 Oct 2012 17:53 GMT
Source: reuters // Reuters

Oct 11 (Reuters) - Two more people have died from fungal meningitis linked to steroid injections, bringing the total to 14 deaths since the outbreak began last month, the U.S. Centers for Disease Control said on Thursday.

A total of 170 people have been stricken with a rare fungal meningitis in 11 states since the outbreak began, according to the latest CDC tally, up from 137 listed on Wednesday.

Florida reported its second death in the outbreak and Indiana its first death in the outbreak. The CDC also confirmed the first case in Idaho, the 11th state to report a case...

[Catbird]

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

CDC Daily Update

Multistate Meningitis Outbreak Investigation

October 11, 2012 1:30 PM EDT

Current Situation

As of October 10, 2012, CDC?s fungal disease laboratory has confirmed the presence of the fungus Exserohilum in 10 people with meningitis and the fungus Aspergillus in one person with meningitis.

Clinicians should continue to contact patients who have received medicines associated with three lots of preservative-free methylprednisolone acetate (80mg/ml) from the New England Compounding Center (NECC) that were recalled on September 26, 2012. The potentially contaminated injections were given starting May 21, 2012. See updated Clinician Guidance webpage for more information.

CDC's guidance to patients has not changed as a result of the expanded voluntary recall of all NECC products, announced October 6. Patients who feel ill and are concerned about whether they received a medication from one of the NECC products recalled on September 26 should contact their physician.

Onset of symptoms is typically 1 to 4 weeks following injection, but there are also reports of shorter and longer periods of time between injection and onset of symptoms. See updated Patient Guidance.


At-A-Glance

Status: Ongoing Investigation
Infection: Fungal Meningitis
Facility Type: Outpatient Setting
Case Count: 170
States: 11
Deaths: 14

[Emily]

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

There's a lot of confusing information in the press claiming the FDA had no inspection or regulatory powers over compounding pharmacies that could have prevented a disaster like the current one and that giving the FDA broader approval powers would make us safer, but this warning letter from the FDA to NECC suggests otherwise:

http://www.fda.gov/ICECI/Enforcement.../ucm076196.htm

WARNING LETTER
NWE-06-07W
VIA FEDERAL EXPRESS

December 4, 2006
Barry J. Cadden, Director of Pharmacy and Owner
New England Compounding Center
697 Waverly Street
Framingham, MA 01702

Dear Mr. Cadden:

On September 23, 2004, investigators from the U.S. Food and Drug Administration (FDA) and the Massachusetts Board of Pharmacy inspected your firm, located at 697 Waverly Street, Framingham, Massachusetts. On January 19, 2005, the inspection was completed. This inspection revealed that your firm compounds human prescription drugs in various dosage forms and strengths.

We acknowledge the receipt of your October 1, 2004, letter addressed to FDA's New England District Office, concerning questions presented during the referenced inspection.

FDA's position is that the Federal Food, Drug, and Cosmetic Act (FDCA) establishes agency jurisdiction over "new drugs," including compounded drugs. FDA's view that compounded drugs are "new drugs" within the meaning of 21 U.S.C. ? 321(p), because they are not "generally recognized, among experts . . . as safe and effective," is supported by substantial judicial authority. See Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609, 619, 629-30 (1973) (explaining the definition of "new drug"); Prof'ls & Patients for Customized Care v. Shalala, 56 F.3d 592, 593 n.3 (5th Cir. 1995) (the FDCA does not expressly exempt pharmacies or compounded drugs from its new drug provisions); In the Matter of Establishment Inspection of: Wedgewood Village Pharmacy, 270 F. Supp. 2d 525, 543-44 (D.N.J. 2003), aff'd, Wedgewood Village Pharmacy v. United States, 421 F.3d 263, 269 (3d Cir. 2005) ("The FDCA contains provisions with explicit exemptions from the new drug . . . provisions. Neither pharmacies nor compounded drugs are expressly exempted."). FDA maintains that, because they are "new drugs" under the FDCA, compounded drugs may not be introduced into interstate commerce without FDA approval.

The drugs that pharmacists compound are not FDA-approved and lack an FDA finding of safety and efficacy. However, FDA has long recognized the important public health function served by traditional pharmacy compounding. FDA regards traditional compounding as the extemporaneous combining, mixing, or altering of ingredients by a pharmacist in response to a physician's prescription to create a medication tailored to the specialized needs of an individual patient . See Thompson v. Western States Medical Center, 535 U.S. 357, 360-61 (2002). Traditional compounding typically is used to prepare medications that are not available commercially, such as a drug for a patient who is allergic to an ingredient in a mass-produced product, or diluted dosages for children.

Through the exercise of enforcement discretion, FDA historically has not taken enforcement actions against pharmacies engaged in traditional pharmacy compounding. Rather, FDA has directed its enforcement resources against establishments whose activities raise the kinds of concerns normally associated with a drug manufacturer and whose compounding practices result in significant violations of the new drug, adulteration, or misbranding provisions of the FDCA.

FDA's current enforcement policy with respect to pharmacy compounding is articulated in Compliance Policy Guide (CPG), section 460.200 ["Pharmacy Compounding"], issued by FDA on May 29, 2002 (see Notice of Availability, 67 Fed. Reg. 39,409 (June 7, 2002)).1 The CPG identifies factors that the Agency considers in deciding whether to initiate enforcement action with respect to compounding. These factors help differentiate the traditional practice of pharmacy compounding from the manufacture of unapproved new drugs. They further address compounding practices that result in significant violations of the new drug, adulteration, or misbranding provisions of the FDCA. These factors include considering whether a firm compounds drugs that are copies or essentially copies of commercially available FDA-approved drug products without an FDA sanctioned investigational new drug application (IND). The factors in the CPG are not intended to be exhaustive and other factors may also be appropriate for consideration.

[snip]

3. Repackaging;

Additionally, we are in receipt of a complaint alleging that you are repackaging the approved injectable drug, Avastin, into syringes for subsequent promotion and sale to health professionals . Avastin is unpreserved and is packaged and labeled in 4 and 16 ml single-use glass vials. The labeled precautions include "discard any unused portion left in a vial . . . ." Each step in the manufacture and processing of a new drug or antibiotic, from handling of raw ingredients to final packaging, must be approved by FDA, whether carried out by the original manufacturer or by some subsequent handler or repacker of the product. Pharmacists are not exempt from these statutory requirements. Generally, the agency regards mixing, packaging, and other manipulations of approved drugs by licensed pharmacists, consistent with the approved labeling of the product, as an approved use of the product if conducted within the practice of pharmacy, i.e., filling prescriptions for identified patients. However, processing and repacking (including repackaging) of approved drugs is beyond the practice of pharmacy and is thus subject to the Act's premarket approval requirements.

The agency has an established policy, articulated in Compliance Policy Guide Sec. 446.100, Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations (CPG 7132c.06) (copy enclosed), concerning the manipulation of approved sterile drug products outside the scope of the FDA-approval. FDA is particularly concerned about the manipulation of sterile products when a sterile container is opened or otherwise entered to conduct manipulations. The moment a sterile container is opened and manipulated, a quality standard (sterility) is destroyed and previous studies supporting the standard are compromised and are no longer valid. We are especially concerned with the potential microbial contamination associated with splitting Avastin - a single-use, preservative-free, vial -- into multiple doses. When used intravitreaily, microbes could cause endophthalmitis, which has a high probability for significant vision loss. The absence of control over storage, and delays before use after repackaging, only exacerbate these concerns.

So it seems the need is not for more broad-based regulations, but for more focus on critical manufacturing of unpreserved drugs, especially those intended for injections, and the ability to followup when problems are found. The real problem in this current outbreak with these injections is sterility, not effectiveness or safety of the active ingredients.

This new article is about an effort to scrutinize the specifics behind the outbreak:

http://www.cbsnews.com/8301-204_162-...nked-pharmacy/

October 11, 2012, 5:43 AM
New allegations in deadly meningitis outbreak

The specialty pharmacy linked to a deadly meningitis outbreak may have misled regulators and done work beyond the scope of its state license, Massachusetts Gov. Deval Patrick said Wednesday...

[sharon sanders]

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

From today's conference it seemed to me that no one was watching the amount of product that was being manufactured and shipped in such large quantities.

It is alleged that the NECC operation was licensed only to produce individual prescriptions.

[Treyfish]

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

CDC: Tests may not detect meningitis fungus
Cases rise to 170 in 11 states
UPDATED 5:22 PM EDT Oct 11, 2012

(CNN) ?
Patients whose fungal tests are negative may still be at risk in a meningitis outbreak, as the fungus involved can be difficult to detect, federal health officials said Thursday.
Cases of the non-contagious fungal meningitis rose to 170 in 11 states as of Thursday, the Centers for Disease Control and Prevention said. Fourteen people have died.

The cases have been linked to injections of contaminated steroid injection made by the Massachusetts-based New England Compounding Center.

Some 14,000 people may have received the injections, the CDC said Thursday, an increase from its previous estimate of 13,000.

Health officials have been able to contact more than 90% of the patients to warn them, officials said.

But "we aren't out of the woods yet," said Dr. J. Todd Weber, incident manager of the multistate outbreak for the CDC.

While the investigation is ongoing, 50 vials of the injection have tested positive for fungus. Those vials were found in the NECC facility, as well as in clinics that received the medication.

CDC's fungal disease laboratory has found the fungus Exserohilum in 10 meningitis patients, and the fungus Aspergillus in one patient.

Exserohilum is new territory for health officials, as it's not typically seen, Weber told reporters Thursday.

However, it can be difficult to find, meaning a patient whose fungal test is negative is not in the clear. Doctors are encouraged to be diligent in following up with patients, he said.


In addition, symptoms from Exserohilum can take a long time to develop. Patients who received the injections should remain vigilant for "at least several months after injection," Weber said.
The average period in which infections are seen is about two weeks, with the longest being 42 days, officials said. However, the longest period a patient may go before developing the disease is not known.

Curing the infection requires a long course of treatment. The CDC is recommending two anti-fungal drugs, which are very strong and can be difficult for patients to tolerate, Weber said.







Read more: http://www.wcvb.com/health/CDC-Tests...#ixzz291vtniiT

[mixin]

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

I also posted part of this article in the Michigan thread but I thought this info would get more exposure in this one.
snip
The person identified by Michigan health officials received the steroid shot in the ankle and has an infection there. (I'm not sure what person this is; I assume it's not the Cass County death).
...

While the biggest concern is for people given the shots for back pain, the CDC said people who received the injections in joints should also be alert to signs of localized infection, including redness, pain, swelling and fever.

http://www.wsbt.com/news/wsbt-meningitis-outbreak-claims-1st-life-in-indiana-20121011,0,2847789.story

[mixin]

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

From today's conference it seemed to me that no one was watching the amount of product that was being manufactured and shipped in such large quantities.

It is alleged that the NECC operation was licensed only to produce individual prescriptions.

This article also mentions violation of state licensing laws prohibiting large scale production but allowing production of medication for patient-specific prescriptions.

http://www.wsbt.com/news/wsbt-meningitis-outbreak-claims-1st-life-in-indiana-20121011,0,2847789.story

[Emily]

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

Catbird's post on the CDC/FDA telebriefing reported that more joint infections are expected.

http://www.flutrackers.com/forum/sho...14&postcount=2

[sharon sanders]

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

It is apparent that the CDC does not know what they are going to find as this situation progresses.

They are evaluating each new case and it appears there is an investigation at the state and federal level into the company that made the compound as well as an investigation into the compound itself.

It is a very fluid situation. They have advised people to keep checking the CDC site for the latest information.

[Nika]

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

The real problem in this current outbreak with these injections is sterility, not effectiveness or safety of the active ingredients.

How hard would it be to use gamma irradiation to sterilize these doses? Is there a biological or technical reason for not doing this?

[cartski]

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

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.

[Nika]

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

is there a CDC/FDA conference call for today?

[sharon sanders]

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

We do not have any notice of one.

There was a Florida media conference a few minutes ago that announced 2 more cases with a total in Florida of 9.

[Catbird]

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

TN is holding a conference now. I'll post the notes when it's over.

ETA: Live blog notes are posted in the Tennessee thread.

[Catbird]

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

Today's CDC status report:

• Status: Ongoing Investigation
• Infection: Fungal Meningitis
• Facility Type: Outpatient Setting
• Case Count: 185
• States: 12
• Deaths: 14

There were no updates to Patient or Clinicians Guidance.