CDC HAN Advisory: Additional NECC Products Found Contaminated

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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

FDA: Ameridose Announces Voluntary Recall Of All Products

Photo Credit CDC

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Ameridose, a sister company to the New England Compounding Center (NECC) – the pharmacy at the center of investigation involving contaminated steroid products – has announced a voluntary recall of all of their products as their facilities are coming under review by the FDA.

 

The FDA reassures that - This recall is not based on reports of patients with infections associated with any of Ameridose’s products, and the agency recommended this recall out of an abundance of caution.

 

The company posted a carefully worded announcement on their website earlier today:

 

Ameridose Issues Recall of All Products

Contact:
Consumer:
888-820-0622
amdservice@ameridose.com

FOR IMMEDIATE RELEASE - October 31, 2012 - Ameridose today announced it will commence a voluntary recall of any unexpired products remaining in circulation. This action is voluntary, and represents an expansion of our cooperation with the U.S.Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy.

 

During the course of its on-going inspection of our facility, FDA has notified Ameridose that it will be seeking improvements in Ameridose’s sterility testing process.  Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death.

(Continue . . .)

 

 

The first sentence in the second paragraph of their press release, which reads . . .

 

During the course of its on-going inspection of our facility, FDA has notified Ameridose that it will be seeking improvements in Ameridose’s sterility testing process.

 

. . .  is apparently their interpretation of the FDA’s assessment from below, which states:

 

FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility.

 

Without comment, I'll also mention that both parties managed to agree that injecting non-sterile products is generally a bad idea, and represents a - `serious hazard to health and could lead to life-threatening injuries and/or death’.

 

Moving on.   Here is the FDA’s statement in its entirety.

 

 

    FDA NEWS RELEASE

For Immediate Release: Oct. 31, 2012
Media Inquiries: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA reports voluntary recall of all Ameridose drug products

The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo . A complete list of all products subject to this recall can be accessed at www.ameridose.com .

 
The FDA is currently conducting an inspection of Ameridose’s facility. Although this inspection is ongoing, the FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. Use of non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries. Most products produced at and distributed by this facility are represented by Ameridose to be sterile products. Ameridose entered into a voluntary agreement with the Massachusetts Board of Registration in Pharmacy to cease all pharmacy and manufacturing operations starting on Oct. 10, 2012.

 

This recall is not based on reports of patients with infections associated with any of Ameridose’s products, and the agency recommended this recall out of an abundance of caution. Therefore, at this time, the FDA is also recommending that health care professionals do not need to follow up with patients who received Ameridose products. Health care professionals should stop using Ameridose products at this time, and return them to the firm.

 

Hospitals, clinics, health care professionals, and other customers with Ameridose products on hand should contact Ameridose at 888-820-0622 to obtain instructions on how to return products to Ameridose.

 

“The FDA’s top priority is to ensure that drugs are safe for the American public,” said FDA Commissioner Margaret A. Hamburg, M.D.

 

Together with the State of Massachusetts, the FDA commenced the current inspection of the Ameridose facility as part of the agency’s ongoing fungal meningitis outbreak investigation. Ameridose is a company sharing common management by the same parties as New England Compounding Center (NECC) of Framingham, Mass., the firm associated with compounded drugs linked to the ongoing fungal meningitis outbreak.

 

“Because the preliminary results of the FDA’s inspection raise concerns about the sterility assurance of Ameridose’s products, the FDA is advising health care professionals to stop using all Ameridose products and follow the recall procedures provided by the firm,” explained Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.

 

The FDA has identified some Ameridose products that currently appear on the critical shortage list. These products were in shortage before the Ameridose recall, but supplies may be further affected as a result of the Ameridose recall. The FDA is working with alternative manufacturers to maintain supplies of these life-saving drugs.

 

“The agency is taking all steps within its authority to help prevent or alleviate shortage situations and to minimize the impact this recall may have on drug supplies,” added Commissioner Hamburg.

 

As new information becomes available, the FDA will issue additional public communications.

 

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

 

The FDA asks health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch Program by fax at 800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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

 

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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