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Published Date: 2012-10-09 11:38:13
Subject: PRO/EDR> Aspergillus meningitis - USA (06): CDC advice
Archive Number: 20121009.1333004

ASPERGILLUS MENINGITIS - USA (06): CDC ADVICE
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In this posting:
[1] Query
[2] CDC: statistics
[3] CDC: frequently asked questions for clinicians - multistate meningitis outbreak

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[1] Query
Date: Mon 8 Oct 2012
From: Danyelle Redden <danyelleredden@gmail.com> [edited]

Are there any official recommendations for patients who received potentially contaminated injections but are asymptomatic? Should these patients undergo lumbar puncture? They are beginning to show up in my emergency department.

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Danyelle Redden, MD, MPH
Orlando, FL
USA
<danyelleredden@gmail.com>

[Dr Redden's question is one being asked quite frequently among patients who received injections from the recalled lots and their doctors. Below are the latest, and rising, statistics [2] and below that recommendations from the Centers for Disease Control and Prevention [CDC] addressing this question [3]. Essentially, if the patient is totally asymptomatic, there is no indication for lumbar puncture but there should be a low threshold for the procedure. - Mod.LL]

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[2] CDC: statistics
Date: Mon 8 Oct 2012
Source: CDC, Healthcare-Associated Infections (HAIs) [edited]
http://www.cdc.gov/HAI/outbreaks/meningitis.html

At-a-glance
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Status: ongoing investigation
Infection: fungal meningitis
Facility type: outpatient setting
Case count: 105
States: 9
Deaths: 8

A map of the current case count can be found at http://www.cdc.gov/hai/outbreaks/meningitis-map.html
Tennessee 35, Virginia 23, Michigan 21, Indiana 11, Maryland 5, Florida 4, Minnesota 3, North Carolina 2.

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[3] CDC: frequently asked questions for clinicians -- multistate meningitis outbreak
Date: Sun 7 Oct 2012
Source: CDC, Healthcare-Associated Infections (HAIs) [edited]
http://www.cdc.gov/hai/outbreaks/clinicians/faq_meningitis_outbreak.html

CDC is aware that New England Compounding Center [NECC] has voluntarily expanded its recall to include all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts. CDC's guidance to patients has not changed as a result of this voluntary recall. Patients who feel ill and are concerned about whether they received a medication from NECC should contact their physicians.

Clinicians should actively contact patients who have received medicines associated with 3 lots of preservative-free methylprednisolone acetate (80 mg/mL) recalled on 26 Sep 2012. The potentially contaminated injections were given starting 21 May 2012. Symptoms that should prompt diagnostic evaluation include: fever, new or worsening headache, neck stiffness, sensitivity to light, new weakness or numbness, increasing pain, redness or swelling of the injection site.

What is causing these infections?
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The infections are caused by a fungus. At this point, the original source of the outbreak has not been determined; however, all infected patients identified thus far have received preservative-free (PF) methylprednisolone acetate (80 mg/mL) from among the 3 lots voluntarily recalled by the New England Compounding Center in Framingham, MA.

What should physicians be doing?
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1. Find out if you have administered a potentially contaminated medication from New England Compounding Center. The 3 potentially contaminated lots are:
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot No. 05212012@68, BUD 11/17/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot No. 06292012@26, BUD 12/26/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot No. 08102012@51, BUD 2/6/2013

2. Contact patients who have been exposed. All patients who have received medication from 1 of these 3 lots should be immediately contacted directly (that is, called) to determine if they are having any symptoms. It is important to note that infected patients have presented with mild symptoms, only slightly worse than baseline.

3. Refer symptomatic patients for a diagnostic procedure. For patients who received epidural injection with medication from the lots listed above and have any symptoms of meningitis or basilar stroke, a diagnostic lumbar puncture (LP) should be performed, if not contraindicated. Because presenting symptoms of some patients with meningitis have been mild and not classic for meningitis (such as new or worsening headache without fever or neck stiffness), physicians should have a low threshold for LP.

While CDC is only aware of infections occurring in patients who have received epidural steroid injections, patients who received other types of injection (such as joint injection) with potentially contaminated methylprednisolone acetate should also be contacted to assess for signs of infection (such as swelling, increasing pain, redness, warmth at the injection site) and should be encouraged to seek evaluation (such as an arthrocentesis) if such symptoms exist.

Interim instructions regarding diagnostic testing and treatment options are available at http://www.cdc.gov/hai/outbreaks/clinicians/index.html.

4. Report concerning cases to public health. Physicians should report suspected cases to their state health department.

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 http://www.fda.gov/medwatch.

Is there a role for prophylaxis?
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Currently, CDC emphasizes the need for rapid clinical evaluation and diagnosis, if indicated. Prophylaxis is not recommended at this time.

Is there a role for lumbar puncture in asymptomatic patients?
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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 if the patient should become symptomatic. The clinical investigation of patients associated with this outbreak is ongoing, and this recommendation may change as new information becomes available.

Were the 3 lots mentioned above only used for spinal injections?
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No. These medications were used for other types of injections, including injections into the joint (such as the knee). To date, CDC has only identified infections in patients who received epidural steroid injections with these medications. However, patients who received other types of injections with these products may also be at risk.

What states have received the potentially contaminated medication?
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23 states have received medication from the New England Compounding Center:
California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, West Virginia

The names of the facilities that have received medication from one of these lots are available at http://www.cdc.gov/hai/outbreaks/meningitis-facilities-map.html.

Are other medications from the New England Compounding Center associated with infections?
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To date, CDC has not received reports of infections linked to other products from the New England Compounding Center. However, out of an abundance of caution, CDC recommends that patients cease use of any product produced by the New England Compounding Center until further information is available. A list of products produced by the New England Compounding Center can be found through the FDA website at http://www.fda.gov/Drugs/DrugSafety/ucm322734.htm.

If patients have taken or used medications from New England Compounding Center, and they are worried that they are ill because of use of one of these products, they should seek medical attention. Again, CDC has not received any reports of infection linked to other products from New England Compounding Center.

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[Other sites of infection may be recognized as the medication is used for indications outside epidural injection in sites such as joints.

It has not yet been reported from CDC what the date (or dates) of injection were and what the 1st day of symptoms. Likewise, the one species (or more) of _Aspergillus_ has not been reported. - Mod.LL]

See Also