FDA launches effectiveness study of healthcare antiseptics
The US Food and Drug Administration (FDA) today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain ingredients used in over-the-counter healthcare antiseptics, the agency said in a news release.
Healthcare antiseptics are primarily used in hospitals, clinics, outpatient settings, and long-term-care facilities. They include hand washes and rubs, surgical hand scrubs and rubs, and patient preoperative skin preparations, the FDA said. Their most common active ingredients are alcohol and iodines. The rule does not cover consumer antiseptics like antibacterial soaps and hand sanitizers.
The rule will be published tomorrow in the Federal Register, and the FDA is allowing 180 days for public comment. The rule lists 25 antiseptics that the agency will assess, plus 3 combination products. The FDA recommends their continued use while researchers gather data.
"Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the agency is requesting additional scientific data to demonstrate that health care antiseptics in the over-the-counter drug monograph are generally recognized as safe and effective (GRASE) for their intended use to reduce bacteria that potentially can cause disease," the agency said in the release.
"The FDA's request for more safety and effectiveness data for health care antiseptic active ingredients should not be taken to mean the FDA believes that these products are ineffective or unsafe."
The FDA last thoroughly assessed these products in 1994. The agency said emerging science suggests that for at least some healthcare antiseptic active ingredients, systemic exposure as shown by detection of antiseptic ingredients in the blood or urine is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily exposure.
The Association for Professionals in Infection Control and Epidemiology (APIC) and the Society for Healthcare Epidemiology of America (SHEA) today strongly supported the FDA's actions. "Since all infection prevention and control guidelines are evidence-based, it is important to stay up-to-date on safety and effectiveness data to protect healthcare personnel and their patients," the societies said in a joint statement.
Apr 30 FDA news release
Apr 30 FDA proposed rule
Apr 30 APIC/SHEA statement
NDM-1 in Dhaka water raises flag for rapid rise in drug-resistant bacteria
The carbapenemase NDM-1, an enzyme that fosters the spread of extensively drug-resistant bacteria, has made its way very recently into a large portion of the environmental waters of Dhaka, Bangladesh, and is likely to continue its rapid spread, say the findings of a study published yesterday in Emerging Infectious Diseases.
The authors, from Cardiff University in Wales, tested environmental water/sewage samples from 58 sites in seven regions of Dhaka in October 2012 for NDM-1 (New Delhi metallo-beta-lactamase variant 1) and found it was present in samples from 36 (62%) of the sites.
They also found high rates of NDM-1 in gram-negative bacteria, particularly Escherichia coli, in gut samples. Gut carriage can lead to contamination of drinking water and food because of poor sewage treatment. In addition, since E coli causes common community-acquired infections that often require hospitalization, the likelihood of NDM-1–encoding E coli moving between the community and the hospital increases as gut carriage of the bacteria spreads.
The authors say testing for NDM-1 in Dhaka water in 2008-09 did not detect its presence, nor did testing of gut samples in 2009-10, pointing to the rapidity with which it has spread.
Apr 29 Emerg Infect Dis study
Reports: 6 melioidosis cases in arid Australia, vaccine candidate progress
Burkholderia pseudomallei, the agent that causes melioidosis, a disease of animals and humans that typically occurs in wet, tropical areas, can survive in harsh and even desert environments, as evidenced by an Emerging Infectious Diseases dispatch yesterday that detailed six human cases of the disease in the normally arid interior of Australia.
The cases occurred over a 4-month period in 2011 after heavy rains and flooding in central Australia, which has a desert climate with low rainfall and often-dry riverbeds. None of the case-patients had traveled overseas or to the tropical part of the country, which lies in the north.
All patients lived below the 20th latitude south; melioidosis historically occurs between latitudes 20 degrees south and 20 degrees north. Half the patients were male and half female; five were indigenous Aboriginal Australians.
Three required intubation and ventilation for severe bacteremia. All received intravenous ceftazidime or meropenem followed by trimethoprim/sulfamethoxazole or a similar agent according to standard guidelines, and all survived. Multilocus sequence typing showed each of the isolates to be novel and unique, and none had any known single-locus variants.
Outbreaks of meloidosis are not unheard of in the dry areas of Australia after flooding but have been rare. The authors say that "the geographic boundaries of B pseudomallei across the vast interior of the Australian continent and the extent of incursion into southern Australia remain entirely unclear," that further study is needed, and that the diagnosis of meliodosis should be considered in the area, particularly after heavy rains and flooding.
Apr 29 Emerg Infect Dis dispatch
In other melioidosis news, another report in Emerging Infectious Disease says consensus among a group of experts at a March 2014 meeting was reached on steps for advancing to the next stage of development of vaccines against B pseudomallei.
To date, no standardized protocols have existed for the testing of candidate vaccines, meaning direct comparisons between them have not been possible, plus partial effectiveness has been demonstrated only in murine models.
The meeting included members of the Steering Group on Melioidosis Vaccine Development (SGMVD), which was established in 2013, plus several additional experts from the United Kingdom and the United States.
It was agreed that a gateway system similar to that used for tuberculosis vaccine candidates will be used. Head-to-head comparison of the candidate vaccines using standardized mouse models and a defined set of testing criteria will be carried out by an independent institute, after which vaccines to test in non-human primates will be selected.
A melioidosis vaccine is "urgently needed," for public health purposes, say the authors, but also for biodefense, in that B pseudomallei is categorized as an agent at high risk of "deliberate misuse as a weapon."
Apr 29 Emerg Infect Dis report