Duloxetine and Pregnancy Outcomes: Safety Surveillance Findings.

Duloxetine and pregnancy outcomes: safety surveillance findings.

Int J Med Sci. 2013; 10(4): 413-9
Hoog SL, Cheng Y, Elpers J, Dowsett SA

Duloxetine hydrochloride is approved for the treatment or management of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, chronic musculoskeletal pain, and fibromyalgia in the United States. These conditions affect millions of women, including those of childbearing potential. In pregnancy, pharmacological treatment is justified only if the potential benefits outweigh potential risks to mother and fetus, neonate or infant. There are no adequate and well-controlled studies in pregnant women treated with duloxetine. Post-marketing surveillance is an important tool for the assessment of drug safety in pregnancy in a naturalistic setting. Using safety surveillance and spontaneous adverse events reporting databases, to provide pregnancy outcomes statistics as they relate to duloxetine exposure. This was an analysis of pregnancy outcome data captured in Lilly Safety System (LSS) (a safety database for the collection, storage, and reporting of adverse events involving Lilly Products), through October 31 2011 and the FDA Adverse Events Reporting System (AERS) database through September 30 2011. Both databases provided spontaneous reporting data from the time of first duloxetine marketing authorization in 2004; in addition, the LSS Database includes serious adverse event and pregnancy data from clinical trials since the creation of the database in 1983. Patients who had received duloxetine during pregnancy and reported pregnancy outcomes. Normal and abnormal pregnancy outcomes. Abnormal outcomes comprised spontaneous abortion, premature/post-term birth, congenital anomaly, perinatal/post-perinatal complication, still birth, and ectopic pregnancy. Descriptive statistics are provided for LSS data. A disproportionality analysis was performed using the Empirical Bayes Geometric Mean (EBGM) for the AERS data. The lower bound of the 90% confidence interval of EBGM (EB05) ?1 was used as the threshold to determine disproportionality. In the LSS analysis, 400 pregnancy cases with a known pregnancy outcome were identified. Of the 233 prospectively reported cases, 170 (73%) were spontaneous reports; the remainder were reported from clinical trials (58 [25%]) or post-marketing studies (5 [2%]). In most of these cases (74%), patients received duloxetine for the treatment of depression. Pregnancy outcomes were normal in 143 cases, and abnormal in 90 cases. Abnormal pregnancy outcomes were mainly spontaneous abortions (n=41), post/perinatal conditions (n=25) or premature births (n=19). In patients with abnormal pregnancy outcomes, relevant concomitant medication use and relevant medical history were more frequently reported, compared to those with normal pregnancy outcomes (p<0.05). For the AERS database analysis, EB05 was less than one for all clusters of abnormal pregnancy outcomes; there was no disproportionality of reporting adverse pregnancy outcomes for patients treated with duloxetine versus all other drugs or selected antidepressants. While limitations of these data are recognized, the information available to date from these two data sources suggest that the frequency of abnormal outcomes reported in duloxetine pregnancy cases is generally consistent with the historic control rates in the general population. HubMed – depression


Suicide risk of your client: initial identification and management for the allied health professional.

J Allied Health. 2013; 42(1): 56-61
Donley E

Allied health professionals treat clients in varying degrees of distress with complex needs in a wide range of services. A client could be experiencing a chronic or life-changing illness, have a trauma from a critical event, have preexisting mental illness, be dealing with significant health or personal loss, be using substances, or experiencing a depression. At some point an allied health professional will treat a client who may have a diagnosed depression, appear depressed, or have thoughts of suicide. Mental health of clients is everyone’s responsibility, especially those working in health. This article aims to increase allied health professionals’ understanding of some risk factors and clinical features a client at risk may have and will discuss some initial options of management. It is recommended the allied health professional and organisation be aware of risk factors for suicide but not rely too heavily on risk screening. The worker should have basic skills in recognising poor mood and have a list of useful questions to ask in a crisis. Know your local crisis and supportive mental health services, create links with them, have ongoing professional education and protocols for managing clients at-risk, and be acutely aware of your role and limitations. HubMed – depression


Needs regarding care and factors associated with unmet needs in disease-free survivors of surgically treated lung cancer.

Ann Oncol. 2013 Mar 6;
Yun YH, Shon EJ, Yang AJ, Kim SH, Kim YA, Chang YJ, Lee J, Kim MS, Lee HS, Zo JI, Kim J, Choi YS, Shim YM

BackgroundTo evaluate the long-term needs of lung cancer survivors and to explore factors associated with unmet need.Patients and methodsWe recruited lung patients treated with curative surgery from 2001 through 2006 at two centers in Korea. Needs in the domains of information, supportive care, education and counseling, and socioeconomic support were measured. We selected the four most frequently reported items of unmet need among 19 items in four domains.ResultsThe most frequently reported unmet needs were Complementary and alternative medicine (CAM) and folk remedies (59.8%) in the Information domain, Counseling and treatment of depression and anxiety (63.5%) in the Supportive care domain, diet, exercise and weight control (55.1%) in the Education and counseling domain and Financial support (90.4%) in the socioeconomic support domain. Unmet needs for psychological treatment was significantly greater in participants who were employed (adjusted odds ratio [aOR], 2.25; 95% confidential interval [CI], 1.12 to 4.53). Unmet needs for diet, exercise and weight control were significantly greater in participants who had not received chemotherapy (aOR, 1.76; 95% CI, 1.09 to 2.85). Unmet need for financial support was greater in participants who were married (aOR, 4.14, 95%CI, 1.12 to 15.22) and those who had not received chemotherapy (aOR, 5.91, 95%CI, 1.91 to 18.31).ConclusionThere were substantial unmet needs for information regarding psychological support, education for diet and exercise, and financial support among lung cancer survivors. HubMed – depression



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