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Published Date: 2013-05-25 23:55:31
Subject: PRO/EDR> Fungal infection, contaminated drug - USA (07): new outbreak, RFI
Archive Number: 20130525.1737028

FUNGAL INFECTION, CONTAMINATED DRUG - USA (07): NEW OUTBREAK, RFI
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[1]
Date: Thu 24 May 2013
Source: FDA [edited]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm353941.htm

The FDA is working closely with the CDC and Tennessee Board of Pharmacy to investigate reports of 7 adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, TN.

Out of an abundance of caution, the FDA recommends that health care providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided.

The reports of adverse events are all from patients who received preservative-free methylprednisolone acetate (80 mg/mL) by injection. To date, the FDA has received 7 reports. Clinical information about these patients is pending; at least 1 of these adverse events appears to involve fungus.

An investigation into the exact source of these adverse events is still ongoing, but these cases are associated with a potentially contaminated medication. As part of the ongoing investigation, the FDA will continue to work closely with the CDC and state authorities to thoroughly review the sterile practices at Main Street.

The FDA asks health care providers and consumers to report adverse events or quality problems experienced with the use of any Main Street products to the FDA's MedWatch Adverse Event Reporting program.

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[2]
Date: Fri 24 May 2013
Source: New York Times [edited]
http://www.nytimes.com/2013/05/25/health/abscesses-reported-after-steroid-injections.html?_r=0

At least 7 people have reported complications after being injected with a potentially contaminated medication made in a pharmacy in Tennessee, federal and state health officials said. The FDA said that it had not yet determined the nature of the illnesses, but that at least 1 person seemed to have a fungal infection. Last fall, fungal contamination of the same type of medication, an injectable steroid produced by a compounding pharmacy in Massachusetts, caused the deaths of more than 50 people. Officials in North Carolina, where 2 of the new cases were found, said that the symptoms were skin abscesses and that there had been no reports of meningitis, stroke or other life-threatening conditions. Illinois said it was investigating 5 cases of patients who developed abscesses after receiving the medication, which is used to treat back pain and swelling in joints, among other conditions.

[Byline: Sabrina Tavernise]

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[The size of this new outbreak of seemingly fungal infections caused by contamination of a compounding pharmacy-produced corticosteroid for injection is too early to know. The previous huge outbreak also began with just a handful of cases reported. ProMED awaits more information regarding the amount of vials distributed to which states and which fungus was isolated.

It is time to allow FDA to be able to oversee this industry by providing not only the proper legislation but also the money and manpower to do the job correctly. Below is a partial list of reported clusters of infections linked to supposedly sterile products produced by compounding pharmacies, almost all in the USA:

1. Perz JF, Craig AS, Stratton CW, et al: _Pseudomonas putida_ septicemia in a special care nursery due to contaminated flush solutions prepared in a hospital pharmacy. J Clin Microbiol 2005; 43(10): 5316-8
2. Held MR, Begier EM, Beardsley DS, et al: Life-threatening sepsis caused by _Burkholderia cepacia_ from contaminated intravenous flush solutions prepared by a compounding pharmacy in another state. Pediatrics 2006; 118(1): e212-5
3. Civen R, Vugia DJ, Alexander R, et al: Outbreak of _Serratia marcescens_ infections following injection of betamethasone compounded at a community pharmacy. Clin Infect Dis 2006; 43(7): 831-7
4. Sunenshine RH, Tan ET, Terashita DM, et al: A multistate outbreak of _Serratia marcescens_ bloodstream infection associated with contaminated intravenous magnesium sulfate from a compounding pharmacy. Clin Infect Dis 2007; 45(5): 527-33
5. Gershman MD, Kennedy DJ, Noble-Wang J, et al: Multistate outbreak of _Pseudomonas fluorescens_ bloodstream infection after exposure to contaminated heparinized saline flush prepared by a compounding pharmacy. Clin Infect Dis 2008; 47(11): 1372-9
6. Maragakis LL, Chaiwarith R, Srinivasan A, et al: _Sphingomonas paucimobilis_ bloodstream infections associated with contaminated intravenous fentanyl. Emerg Infect Dis 2009; 15(1): 12-8
7. Sunenshine R, Schultz M, Lawrence MG, et al: An outbreak of postoperative Gram-negative bacterial endophthalmitis associated with contaminated trypan blue ophthalmic solution. Clin Infect Dis 2009; 48(11): 1580-3
8. Lee SH, Woo SJ, Park KH, et al: _Serratia marcescens_ endophthalmitis associated with intravitreal injections of bevacizumab. Eye (Lond) 2010; 24(2): 226-32
9. Goldberg RA, Flynn HW, Isom RF, Miller D, Gonzalez S: An outbreak of _Streptococcus_ endophthalmitis after intravitreal injection of bevacizumab. Am J Opthalmol 2012; 153(2): 204-8
- Mod.LL

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See Also

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Fungal infection, contaminated drug - USA (02) 20130130.1521840
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2012
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Fungal infection, contaminated drug - USA (15) 20121214.1439451
Fungal infection, contaminated drug - USA (11): complications 20121106.1391405
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Fungal infection, contaminated drug - USA (05) 20121017.1347138
Fungal infection, contaminated drug - USA (04): more medications 20121016.1345302
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Fungal infection, contaminated drug - USA: Exserohilum 20121014.1341591
Aspergillus meningitis - USA (09): Exserohilum 20121011.1337615
Aspergillus meningitis - USA (06): CDC advice 20121009.1333004
Aspergillus meningitis - USA (04): more cases, 2nd fungus 20121007.1328893
Aspergillus meningitis - USA: (TN, NC) contaminated drug 20121002.1320024
2002
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Fungal meningitis, contaminated drug - USA (03) 20021212.6046
Fungal meningitis, contaminated drug - USA: alert (02) 20021117.5831
Fungal meningitis, contaminated drug - USA: 20021002.5444
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