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11/9 Update: Fungal Meningitis Outbreak

Ameridose is a company with the founders similar to the New England Compounding Center (NECC).  NECC is of course the specialty pharmacy tied to a deadly meningitis outbreak.  Ameridose has agreed to extend its voluntary closure until Nov. 19. It was scheduled to reopen on November 5, but on Friday, the state Board of Pharmacy requested the extension.

Case Numbers  There are six critical drugs whose supply will be impacted including local anesthetic drugs, muscle relaxant drugs used during surgery and diuretics used to treat congestive heart failure.  Since Ameridose supplies more than 3,000 hospitals, this impact will be nationwide.

 Center for Disease Control (CDC) – Update on Case Numbers
As of November 8, 2012 (yesterday) here are the counts.

State

Total

Joint

Deaths

Florida (FL)

23

0

3

Georgia (GA)

1

0

0

Idaho (ID)

1

0

0

Illinois (IL)

2

0

0

Indiana (IN)

51

0

4

Maryland (MD)

23

0

1

Michigan (MI)

119

6

7

Minnesota (MN)

11

0

0

New Hampshire (NH)

12

4

0

New Jersey (NJ)

25

0

0

New York (NY)

1

0

0

North Carolina (NC)

3

0

1

Ohio (OH)

16

0

0

Pennsylvania (PA)

1

0

0

Rhode Island (RI)

3

0

0

South Carolina (SC)

1

0

0

Tennessee (TN)

79

0

13

Texas (TX)

2

0

0

Virginia (VA)

50

0

2

TOTALS

424*

10

31

*414 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus 10 peripheral joint infections (e.g., knee, hip, shoulder, elbow). No deaths have been associated with peripheral joint infections.  Case counts by state are based on the state where the procedure was performed, not the state of residence.

This table is from the CDC website.  The numbers are tapering off some what, as expected. Notice there is a column labeled “Joint”.  These are peripheral fungal infections of the hip, knee, shoulder or elbow joints in contrast to the central infections (meningitis). There have been 414 cases of fungal meningitis and 10 of peripheral infections bringing the total to 424 with 31 deaths. Nineteen states remain involved with the most cases in Michigan.  Florida has dropped to 6th in case number. The most deaths have been in Tennessee where the first death occurred.

Further complications of the contaminated lots are now being seen.  Patients are developing abscesses at the site of infection.  Epidural abscesses require patients to be re-hospitalized, treated with antifungal medication and frequently surgery to remove the infected tissue.

Current Back Pain Treatments  As anticipated, doctors are now questioning current approaches to the treatment of back pain.  Old arguments about whether pain management has any effect long-term have risen.  Dependence on quick fixes as ‘cures’ and real questions about what differences, if any, these therapies create.

Additional Infected Medication  The CDC and FDA announced yesterday that contamination has been identified in additional medical products from New England Compounding Center.  Testing revealed contamination by bacteria (Bacillus species) in vials of the drug Betamethasone and in Cardioplegia Solution that were distributed and later recalled by NECC on October 6, 2012.

Betamethasone is a corticosteroid used as a topical cream to relieve skin irritation in patients with eczema and psoriasis.  An oral and injectable form is also produced.  Betamethasone is also administered to mothers to stimulate fetal lung maturation.  It is the injectable form that was found to be contaminated.

Cardioplegia Solution is used during open heart surgery.  While the patient is on cardiopulmonary bypass this high potassium containing solution is injected into the coronary arteries stopping the heart to facilitate the surgery.  Once the bypasses are complete the solution is allowed to wash out and cardiac function is restored. These bacteria are commonly found in the environment and are rarely reported as pathogenic.  When found in patient samples, this bacterium is usually thought to be a skin contaminant.  Different conclusions should be drawn in patients with positive cultures if they have received any of the recalled medications.

MedicationInfected Lot number
Betamethasone08202012@141
Betamethasone07032012@22
Betamethasone07302012@52
Cardioplegia solution09242012@55

Additional microbial organisms may be identified in recalled NECC products as additional laboratory testing is complete.

If you or a family member has been infected with a fungus from an epidural or intra-articular injection you should consult an attorney to know your rights.  The attorneys at Michles & Booth are prepared to help you.  Please call (800) 848-6168. You can always contact us on our website as well.

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