Newborn PPH from antidepressant use?

June 10, 2015

Using SSRI late in pregnancy may increase the risk of persistent pulmonary hypertension in a newborn. Plus, hormone therapy may help mood in early postmenopause; use of mesh for prolapse on the rise

Newborn PPH from antidepressant use?

A cohort study in a large group of publicly insured women seems to indicate that using selective serotonin reuptake inhibitors (SSRI) late in pregnancy may increase the risk of persistent pulmonary hypertension in a newborn.

Researcher used the Medicaid Analytic eXtract for 46 states and Washington DC from 2000 to 2010, with a last follow-up date of December 21, 2010. The pool included 3,789,330 pregnant women who were enrolled in Medicaid from 2 months or fewer after the date of their last menstrual period to at least 1 month after delivery. The source cohort included only women with a diagnosis of depression.

A total of 128,950 (3.4%) women had filled at least 1 prescription of antidepressants late in pregnancy, 102,179 (2.7%) of whom used an SSRI and 26,771 (0.7%) of whom used a non-SSRI. Among the babies not exposed to antidepressants, 7630 were diagnosed with pulmonary hypertension (20.8 per 10,000 births; 95% confidence interval [CI], 20.4-21.3 per 10,000 births) compared with 322 infants exposed to SSRIs (31.5; 95% CI, 28.3-35.2 per 10,000 births) and 78 infants exposed to non-SSRIs (29.1; 95% CI, 23.3-36.4 per 10,000 births).

 

 

The association between pulmonary hypertension in infants and antidepressant use in their mothers was attenuated with increasing levels of confounding adjustment. The odds ratios for SSRIs were 1.51 (95% CI, 1.35 – 1.69) unadjusted and 1.10 (95% CI, 0.94 – 1.29) after restricting to women with depression and adjusting for the high-dimensional propensity score. For non-SSRIs, the odd ratios were (95% CI, 1.12-1.75) and 1.02 (95% CI, 0.77-1.35), respectively. After restricting the outcome to primary pulmonary hypertension, the adjusted odds ratio for SSRIs was 1.28 (95% CI, 1.01-1.64) and for non-SSRIs was 1.14 (95% CI, 0.74-1.74).

The researchers concluded that the study results were consistent with a linkage between increased risk of pulmonary hypertension in infants and SSRI use in their mothers during late pregnancy.  They pointed out that the absolute risk was small and that the increase seems to be more modest than that found in earlier studies.

NEXT: HT may help mood, not cognition, in early postmenopause >>

 

HT may help mood, not cognition, in early postmenopause

In what form a woman takes hormonal therapy (HT) may influence the treatment’s impact on mood in early postmenopause, according to results of a multi-institution study that builds on data from the Women’s Health Initiative (WHI). The findings, from a large randomized clinical trial (RCT), point to greater benefit for mood with pills versus transdermal treatment, but no effects on cognition-positive or negative-for either formulation.

Published in PLOS Medicine, the data are from the Cognitive and Affective Study (KEEPS-Cog) of the Kronos Early Estrogen Prevention Study. The research, the investigators say, is the first large RCT to examine the effect on cognition and mood of two types of HT in healthy women who had undergone hysterectomy and were in the late menopausal transition or early postmenopausal period (within 36 months of the last menstrual period).

At 9 US academic centers, 220 women (average age 52.6) were randomized to 4 years of 0.45 md/d of oral conjugated equine estrogens (EE) plus 200 mg/d of micronized progesterone (m-P) for the first 12 days of each month, 211 were randomized to 50 micrograms/d of transdermal estradiol (t-E2) plus 200 mg/d of m-P for the first 12 days of each month, and 262 women received placebo pills and patches. Primary outcomes were scores on the Modified Mini-Mental State examination; four cognitive factors: verbal learning/memory, auditory attention/working memory, visual attention/executive function, and speeded language/mental flexibility; and a mood measure, the Profile of Mood States (POMS). A linear mixed-effects model was employed to make use of all available data from each participant, even those for whom data were missing. Data from those with and without full data were compared to assess for potential biases resulting from missing observations.

 

 

The researchers hypothesized that treatment with up to 4 years of HT would improve both cognition and mood in healthy recently postmenopausal women but were surprised to find that was not the case for cognition.  Women treated with EE showed a statistically significant change over time in the POMS depression-dejection score (-5.26 x 10-2; effective size [ES] = 0.49, P<0.001), or a medium ES for improvement in the score relative to placebo. The ES of EE on the POMS tension-anxiety subscale was in the small to medium range (-3.01 x 10-2; ES = 0.26, P<0.001).  Transdermal HT was not associated with any improvement on POM subscales, in contrast to results from previous studies. The findings for cognition were similar to that from the WHI Memory Study of Younger women, that is, neither EE nor t-E2 affected cognitive function in the women studied.

Their findings, the authors said “provide valuable information to women considering the various options for managing menopausal symptoms” and “could be incorporated into clinical decisions for cardiovascularly (sic) healthy, non-hysterectomized (sic) women considering whether or not to use” hormones. They noted, however, that the study’s generalizability is limited because the participants were predominantly white, generally well educated, and at low risk of cardiovascular disease. The research also was not powered to assess clinical events such as dementia and the researchers said future studies are needed that directly compare the long-term effects and mechanisms of action of EE and t-E2.

NEXT: Despite warnings, mesh use for prolapse on the rise >>

 

 

Despite warnings, mesh use for prolapse on the rise

Despite the FDA’s warnings about health risks associated with the use of surgical mesh for transvaginal repair of pelvic organ prolapse (POP), use of the device is increasing, according to a study of POP patients in New York state.

At the same time, risks of reinterventions within 1 year and post-surgery urinary retention continue, said the authors of the study, which was published online in BMJ (June 2, 2015).

Researchers at Weill Medical College of Cornell University in New York analyzed a statewide database of nearly 28,000 women who had prolapse repair procedures in the state from 2008 to 2011. More than 7,300 women underwent prolapse repair with mesh and 20,653 had the procedure without mesh.

They found POP repair with mesh rose from 21% in 2008 to 30% in 2011. While more than 62% of the patients in the cohort were younger than 65 years, there were more 65-and-older patients in the mesh group than in the non-mesh group. 

Although post-surgery complications were not common whether surgeons used mesh or not, researchers reported that mesh recipients were more likely than non-mesh recipients to have a reintervention within 1 year and to have urinary retention within 90 days.

In subgroup analyses based on age, researchers found that younger mesh patients had a 66% increased risk of reintervention within 1 year, compared to non-mesh patients. Mesh use was associated with a 36% increased risk of developing in-hospital complications, such as urinary retention, among older patients.

 

 

"This study is addressing the real-world, population-based application of mesh as a medical device, and it yields a different profile for its safety-that mesh is not as safe as people believe it is," said senior author Art Sedrakyan, MD, PhD, in a Weill Cornell news release.

Despite these findings, Dr. Sedrakyan and colleagues said, mesh is not always dangerous and these and other results should not be taken to the extreme.

But the FDA continues to send messages about mesh’s potential harm. The agency has issued proposals that would include the reclassification of surgical mesh used for POP from a moderate-risk to a high-risk, or class III, device.

“The authors present a manuscript which highlights the need and the benefit for patient registries for new surgical implants, such as what we’ve seen with the… POP mesh kits,” Daniel S. Elliott, MD, of Mayo Clinic, Rochester, MN, told Urology Times, a sister publication to Contemporary OB/GYN. “This current large-scale problem that we are dealing with shows the need to change how new surgical products are introduced to the market by industry, and then readily accepted by many surgeons and implanted in unsuspecting patients.”

While patient product registries help to fix the problem, they are not the entire solution, according to Dr. Elliott, who was not involved in the study.

“A registry occurs too late in the process to prevent complications. A registry only serves to alert the surgical community after the problem occurs,” he said. “My argument is that unless medical industry is forced to prove a product’s long-term safety prior to the release of a product (as with what occurred with POP mesh kits), then this whole mesh fiasco is doomed to be repeated. If the medical industry had been forced to definitely prove the long-term benefits of a new medical implant prior to release, and surgeons critically assessed all new products devoid of financial bias or incentive introduced by industry, then this whole POP mesh mess could have been avoided.”