FDA asks manufacturers to withdraw bacitracin from the market
The US Food and Drug Administration (FDA) has requested that manufacturers of bacitracin for injection voluntarily withdraw their products from the market.
In a statement issued late last week, the FDA said that while bacitracin for injection is approved to treat infants who have pneumonia or empyema caused by Staphylococci bacteria, healthcare providers no longer use it for these conditions because there are other effective, FDA-approved treatments that don't have the same serious risks, which include kidney toxicity and anaphylactic reactions. The move follows an April 2019 meeting of the FDA's Antimicrobial Drugs Advisory Committee that ended with an almost unanimous vote that the drug's risks outweigh its benefits.
"Based on FDA's review of currently available data, FDA believes that the potential problems associated with bacitracin for injection are sufficiently serious to remove the drug from the market," the agency said.
Topical or ophthalmic drugs containing bacitracin are not affected by the voluntary withdrawal request.
Jan 31 FDA statement
CRE outbreak continues in Lithuanian hospitals
The European Centre for Disease Prevention and Control (ECDC) today issued a rapid risk assessment on an ongoing hospital outbreak of Klebsiella pneumoniae carbapenemase-producing, carbapenem-resistant Enterobacteriaceae (KPC-CRE) in Lithuania.
The ECDC reports that 223 KPC-CRE cases were detected from Feb 1, 2019, to Jan 7, with 208 cases (93.3%) occurring in a single hospital (hospital 1) and five other hospitals affected. The vast majority of the isolates collected from cases were K pneumoniae (199 cases, 89%), followed by Escherichia coli (21 cases, 9%). Whole-genome sequencing (WGS) revealed that one major K pneumoniae strain—sequence type (ST) 392—was responsible for the outbreak in hospital 1 and was detected in the other five hospitals.
WGS also revealed that the ST392 outbreak strain carried a plasmid containing the blaKPC-2 carbapenemase gene, which was also found in different K pneumoniae sequence types and in E coli and Citrobacter spp isolates, "thus indicating plasmid-mediated spread of carbapenem resistance in addition to clonal expansion of one single CRE strain," the ECDC said.
Additional resistance to the last-resort antibiotic colistin was detected in half of the 52 KPC-CRE isolates for which colistin susceptibility was performed.
The number of CRE cases reported in the outbreak represents a significant increase for Lithuania, which reported only 5 and 12 cases in 2017 and 2018, respectively. The ECDC warns that the risk of continued spread in the Lithuanian healthcare system is likely to be high, since several patients with the outbreak strain have been transferred from hospital 1 to other hospitals. The risk of transmission for people outside the healthcare system is considered low.
Feb 3 ECDC rapid risk assessment
Stewardship program tied to drop in MRSA rates
After implementation of an antibiotic stewardship program involving an infectious disease consultant at four Japanese hospitals, a new study found that decreasing trends for methicillin-resistant Staphylococcus aureus (MRSA) and drug-resistant Pseudomonas aeruginosa (DRPA) accelerated after the program was established, with the drop in MRSA rates increasing by 50% to 150%.
The study appeared Jan 31 in the International Journal of Infectious Diseases.
The stewardship program was implemented at one hospital from 2010 through 2013, and the other three from 2014 through 2017. They collected susceptibility data several years before and during the intervention and compared MRSA and DRPA rates with other hospitals throughout Japan.
Both MRSA and DRPA exhibited decreasing trends (P < 0.01 for all four hospitals and all bacterial cultures) throughout the study period, but the decrease was heightened after the intervention was initiated. The sharper decrease occurred for all DRPA regardless of the antibiotic class assessed (eg, carbapenems), and for MRSA the decline was 50% to 150% steeper among the four hospitals.
Jan 31 Int J Infect Dis study