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Extremely clean rooms may fuel resistance

The prevalence of drug-resistant microbes is a worldwide concern. To investigate how the degree of cleaning and hygiene measures (microbial control) influences the development of antibiotic resistance, a research team compared the microbes present on surfaces of clinical settings (microbiota) with those in other built environments, such as clean rooms subject to strong microbial control in the aerospace industry and public and private buildings with few if any microbial controls. Findings demonstrated that as microbial diversity decreases in areas with high levels of environmental hygiene, the diversity of resistances increases. These results suggest that stable microbial diversity in clinical areas can counteract the spread of drug resistance.


"The microbial control of pathogens is already being successfully used in cultivated plants and also in humans in the framework of stool transplantation," says study coauthor Gabriele Berg, a researcher from the Graz University of Technology in Austria. "Our study provides an initial foundation to pursue such ideas in indoor areas in the future."


Sources: Mahnert A, Moissl-Eichinger C, Zojer M, et al. Man-made microbial resistances in built environments. Nat Commun. 2019;10(1):968. Gratz University of Technology. Excessive hygiene promotes resistance to antibiotics. News release. March 12, 2019.



Exposure raises risk of miscarriage, birth defect

Oral fluconazole, a triazole antifungal agent, may be used to treat fungal infections during pregnancy. Researchers aimed to assess the effect of exposure to low and high doses of fluconazole during pregnancy on the occurrence of spontaneous abortions, major congenital malformations, and stillbirths. In a cohort of 441,949 pregnancies, they found that:


* nearly 70% of women exposed to fluconazole in pregnancy received the common single therapeutic dose of 150 mg (low dose); the remainder received a dose above 150 mg (high dose).


* use of oral fluconazole during early pregnancy was associated with an increased risk of spontaneous abortion compared with no exposure


* fluconazole exposure during the first trimester did not increase the risk of overall major congenital malformations, but exposure to a high dose during the first trimester was associated with an increased risk of cardiac septal closure anomalies compared with no exposure.



No association was found between exposure to fluconazole during pregnancy and the risk of stillbirth. The researchers concluded that "any maternal exposure to fluconazole during pregnancy may increase risk of spontaneous abortion and doses higher than 150 mg during the first trimester may increase risk of cardiac septal closure anomalies." These findings are consistent with prior research. However, the authors of an accompanying editorial stress that risks must be weighed against benefits and that appropriate antifungal therapy "should not be deferred if indicated. A healthy mom is required for a healthy baby."


Sources: Berard A, Sheehy O, Zhao JP, et al. Associations between low- and high-dose oral fluconazole and pregnancy outcomes: 3 nested case-control studies. CMAJ. 2019;191(7):E179-E187. Paquette VC, Elwood C. The safety of oral fluconazole therapy in pregnancy. CMAJ. 2019;191(7):E177-E178. Prenatal fluconazole exposure increases neonatal risks. HealthDay News. February 20, 2019.



New insulin pump helps patients tailor therapy

The Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) has been approved to deliver subcutaneous insulin in children and adults with diabetes. Known as an alternate controller enabled (ACE) infusion pump or ACE insulin pump, it can be used with different components of a patient's diabetes therapy system, allowing the patient to tailor diabetes management according to individual device preferences. Compatible medical devices include automated insulin dosing (AID) systems, continuous glucose monitors (CGM), blood glucose meters, and other electronic devices used for diabetes management. AID systems typically consist of a pump, CGM, and software to control the system. If not digitally connected to communicate with and receive drug dosing commands from other diabetes management devices, the ACE insulin pump can be used to infuse insulin on its own.


Many of the risks associated with use of the new pump are the same as those of other insulin infusion pumps, such as infection, bleeding, pain, and skin irritations. Risks specific to ACE insulin pumps connected to other devices include incorrect drug delivery due to loss of communication between devices, such as the pump misunderstanding commands it receives, or cybersecurity breaches.


Source: US Food & Drug Administration. FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. News release. February 14, 2019.



Nasal spray approved for refractory depression

Used in combination with an oral antidepressant, esketamine nasal spray (Spravato) has been approved to treat adults with depression who have tried other antidepressant medications without an adequate response (treatment-resistant depression). Because this medication can cause significant adverse reactions such as sedation and difficulty with attention, judgment, and thinking (dissociation), it is available only through a Risk Evaluation and Mitigation Strategy (REMS) restricted distribution system. A Boxed Warning details these risks as well as the risk of abuse or misuse and suicidal thoughts and behaviors.


As required by the REMS, the patient self-administers Spravato in the presence of a healthcare provider; the patient cannot take the medication home. The provider must monitor the patient for at least 2 hours after receiving a Spravato dose because of the risk of sedation and dissociation. The REMS also requires both the prescriber and the patient to sign a Patient Enrollment Form that states that the patient understands that he or she should make arrangements to get home safely and that the patient should not drive or use heavy machinery for the rest of the day.


Patients with unstable or poorly controlled hypertension or preexisting aneurysmal vascular disorders may be at increased risk for adverse cardiovascular or cerebrovascular effects. Spravato must be dispensed with a patient Medication Guide that outlines the drug's uses and risks.


Source: US Food & Drug Administration. FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor's office or clinic. News release. March 5, 2019.