FDA Requires Stronger Warnings for Common Insomnia Medications
On Tuesday, the Food and Drug Administration (FDA) announced that several prescription sleep aids must now include aboxed warning—the FDA’s strongest safety warning—following reports of sleepwalking and other rare sleep behaviors that have led to serious injuries and deaths.Sleep aids containing eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist) must carry the boxed warning as well as another warning against the use of the medications by patients with a history of sleepwalking or other rare sleep behaviors like sleep driving.This is not the first time that the FDA has issued a safety alert regarding these medications. In 2013 and 2014, the FDA warned of next-morning impairment associated with zolpidem and eszopiclone."We have closely watched the safety profile of these drugs since they were approved," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "When our ongoing safety monitoring recently reflected the risk of more serious injuries and deaths from patients on these medications who experienced complex sleep behaviors, we determined there was a need to take stronger steps to inform the public."The FDA reviewed 66 reports of serious injuries and deaths that occurred while patients were sleepwalking, sleep driving, or engaging in other activities (such as using a stove) while not fully awake, and most had no memory of the incident. The 46 ...
In this study, we characterized the potential of TAK-137 as a novel antidepressant in rats. In rat primary cortical neurons, TAK-137 increased the phosphorylated form of Akt, extracellular signal-regulated kinase, mTOR, and p70S6 kinase, and dose-dependently increased the expression level of BDNF protein. The antidepressant-like effects of ketamine and TAK-137 were assessed on the day after final administration using the novelty-suppressed feeding test in rats. A single intraperitoneal administration of ketamine shortened the latency to feed. Under these conditions, oral administration of TAK-137 for 3 days shortened the...
CONCLUSIONS: Cabergoline is a safe and effective pharmacologic option for the prevention of physiological lactation and associated physical symptoms in non-breastfeeding women. Future studies should focus on its safety, efficacy and acceptability among WLWH. PMID: 31183987 [PubMed - in process]
Research also finds scale of crisis among African women higher than expectedA landmark study has ended 30 years of anxiety that hormonal contraceptive injections may increase women ’s chances of infection from HIV.But the study found a dramatically higher rate of HIV infection among women in southern Africa than was expected, which one leading campaigning organisation said signified a public health crisis ”.Continue reading...
Conclusion: Overexpression of miR-26a in muscle prevented CKD-induced muscle wasting and attenuated cardiomyopathy via exosome-mediated miR-26a transfer. These results suggest possible therapeutic strategies for using exosome delivery of miR-26a to treat complications of CKD.
Conclusion: Together, our findings uncover the roles of Fto on depression and provide insights into microbiota-related biological mechanisms underlying the association between obesity and depression.
Conclusion: CB may be used as a specific oral antidote for PQ poisoning by strongly binding with PQ and inhibiting its absorption in the gastrointestinal tracts.
Conclusion: The therapy was shown to have antimetastatic action and resulted in normalization of endothelial metabolism, diminution of platelet activation and inhibition of EMT process. The effect was more prominent during early stages of tumor dissemination. Such treatment could be applied to inhibit metastasis during the first stages of this process.
Conclusion: These results revealed the crucial role of the YAP/TAZ-Notch1-NICD axis in liver regeneration. Therefore, BET protein inhibitors must be used in caution in the treatment of hepatic diseases by reason of its suppressive roles in liver regeneration.
Conclusion: Synechococcus elongatus PCC 7942 has the potential as a promising strategy for therapeutic angiogenesis and wound healing primarily by the delivery of functional EVs, not by its photosynthetic activity. The promotion of IL-6 expression may be a mechanism of the cyanobacterium and its EVs-induced pro-angiogenic and -wound healing effects.
ConclusionsThis study helps to extend knowledge of musculoskeletal disorders with the aim of improving the health of professional drivers. The results highlight the importance of designing individual interventions to reduce the incidence of musculoskeletal problems in professional drivers. This would provide greater well-being and lead to a reduction in sick leave.