Why prescription drugs are now the third leading cause of death and the pharmaceutical manufacturers dominance of mental healthcare

James Moore interviews Professor Peter Gøtzsche, Nordic Cochrane Centre Director, 2017

James Moore was keen to talk to Prof. Peter Gøtzsche about his background in research, his views on antidepressant prescribing and how pharmaceutical manufacturers have influenced mental healthcare.

Overview

  • Professor Gøtzsche’s background in clinical trials within the Pharmaceutical industry.
  • How the pharmaceutical manufacturers were manipulating clinical trial data for their own gain.
  • How drug manufacturers have denied for more than 20 years that benzodiazepines and antidepressant drugs cause dependance.
  • How the UK drug regulator (MHRA) also denied this in 2003 at the same time that the World Heath Organisation reported that 3 antidepressants were in the top 30 list of drugs that create dependance.
  • That surveys of patients show that between 50% and 66% of those taking antidepressants experience dependance.
  • The similarities between the pharmaceutical industry and the tobacco industry.
  • That stopping an antidepressant suddenly can be very dangerous.
  • How prescription drugs have become the third leading cause of death behind heart disease and cancer.
  • How pharmaceutical manufacturers have used their power and influence to the detriment of patient safety.
  • That the best science shows that there is no doubt that psychiatric drugs have killed millions of people over the years.
  • How psychotherapy is shown to reduce the risk of suicide but instead we prescribe pills that increase the suicide risk for all ages of patients.
  • That the chemical imbalance lie is still being propagated amongst psychiatrists even thought here is no scientific evidence whatsoever so support it.
  • How psychiatric drugs should be used for acute/emergency situations only.
  • That the medication centred approach of psychiatry does more harm than good.
  • How patients should avoid psychiatric drugs unless they are used for a very short time or that the patient really feels that they need them.
  • That when you look at the randomised controlled trials, there is a large risk of bias in these trials and that antidepressant efficacy has been overstated.
  • That the Cochrane Collaboration undertook the most rigorous meta analysis ever undertaken of 131 trials involving 27,422 patients taking SSRI’s, this analysis showed that antidepressants do not have any meaningful effects and their harms outweigh any benefits there might be.

Sources

Antidepressant use during pregnancy and psychiatric disorders in offspring

Danish nationwide register based cohort study, 2017

What is already known on this topic

  • Several studies have linked selective serotonin reuptake inhibitor use during pregnancy to autism spectrum disorder in offspring, although results have been conflicting
  • The potential explanation for this association is that selective serotonin reuptake inhibitors cross the placental barrier and affect the development of the fetal brain
  • If this holds true, in utero exposure to selective serotonin reuptake inhibitor and other classes of antidepressants may increase risk for various psychiatric disorders besides autism spectrum disorder

What this study adds

  • Antidepressant use during pregnancy was associated with increased risk for various diagnostic groups of psychiatric disorders in offspring
  • The observed associations may be attributable to the severity of underlying maternal psychiatric disorders in combination with in utero antidepressant exposure

Study Abstract

Objective
To investigate the association between in utero exposure to antidepressants and risk of psychiatric disorders.

Design
Population based cohort study.

Setting
Danish national registers.

Participants
905 383 liveborn singletons born during 1998-2012 in Denmark and followed from birth until July 2014, death, emigration, or date of first psychiatric diagnosis, whichever came first. The children were followed for a maximum of 16.5 years and contributed 8.1×106 person years at risk.

Exposures for observational studies
Children were categorised into four groups according to maternal antidepressant use within two years before and during pregnancy: unexposed, antidepressant discontinuation (use before but not during pregnancy), antidepressant continuation (use both before and during pregnancy), and new user (use only during pregnancy).

Main outcome measure
First psychiatric diagnosis in children, defined as first day of inpatient or outpatient treatment for psychiatric disorders. Hazard ratios of psychiatric disorders were estimated using Cox regression models.

Results
Overall, psychiatric disorders were diagnosed in 32 400 children. The adjusted 15 year cumulative incidence of psychiatric disorders was 8.0% (95% confidence interval 7.9% to 8.2%) in the unexposed group, 11.5% (10.3% to 12.9%) in the antidepressant discontinuation group, 13.6% (11.3% to 16.3%) in the continuation group, and 14.5% (10.5% to 19.8%) in the new user group. The antidepressant continuation group had an increased risk of psychiatric disorders (hazard ratio 1.27, 1.17 to 1.38), compared with the discontinuation group.

Conclusions
In utero exposure to antidepressants was associated with increased risk of psychiatric disorders. The association may be attributable to the severity of underlying maternal disorders in combination with antidepressant exposure in utero. The findings suggest that focusing solely on a single psychiatric disorder among offspring in studies of in utero antidepressant exposure may be too restrictive.

  • Antidepressant use during pregnancy and psychiatric disorders in offspring: Danish nationwide register based cohort study, BMJ 2017;358:j3668, 06 September 2017.
  • Characteristics of study population according to maternal antidepressant use before and during pregnancy. Values are numbers (percentages) unless stated otherwise, featured image credit bmj.

Antidepressant Use in Pregnancy and Preterm Birth, ASD, ADHD in Offspring

Is first-trimester maternal antidepressant use related to offspring birth problems, neurodevelopmental problems, or both?

1. Association Between Maternal Use of SSRI Medications and Autism in Their Children

In the February 2016 issue of JAMA Pediatrics, Boukhris and colleagues reported that in utero exposure to selective serotonin reuptake inhibitors (SSRIs) was associated with a significantly increased risk for autism. The authors examined all pregnancies from 1998 to 2009 in the Québec Pregnancy/Children Cohort database that resulted in children with autism spectrum disorder (ASD) as the primary outcome. Among 145 456 full-term infants included in the analysis, 1054 children were diagnosed with ASD by the mean age of 6.2 years (SD, 3.2 years) at follow-up, including 1008 cases of ASD among 140 732 children (0.72%) who were not exposed to antidepressants, and 31 cases of ASD among the 2532 (1.2%) children who were exposed to SSRIs during the second or third trimester. Based on these results, the authors concluded that second- or third-trimester exposure to SSRIs was associated with increased risk for ASD (adjusted hazard ratio, 1.87; 95% CI, 1.15-3.04).

2017 Study Abstract

Importance
The association between the use of antidepressants during gestation and the risk of autism spectrum disorder (ASD) in children is still controversial. The etiology of ASD remains unclear, although studies have implicated genetic predispositions, environmental risk factors, and maternal depression.

Objective
To examine the risk of ASD in children associated with antidepressant use during pregnancy according to trimester of exposure and taking into account maternal depression.

Design, Setting, and Participants
We conducted a register-based study of an ongoing population-based cohort, the Québec Pregnancy/Children Cohort, which includes data on all pregnancies and children in Québec from January 1, 1998, to December 31, 2009. A total of 145 456 singleton full-term infants born alive and whose mothers were covered by the Régie de l’assurance maladie du Québec drug plan for at least 12 months before and during pregnancy were included. Data analysis was conducted from October 1, 2014, to June 30, 2015.

Exposures
Antidepressant exposure during pregnancy was defined according to trimester and specific antidepressant classes.

Main Outcomes and Measures
Children with ASD were defined as those with at least 1 diagnosis of ASD between date of birth and last date of follow-up. Cox proportional hazards regression models were used to estimate crude and adjusted hazard ratios with 95% CIs.

Results
During 904 035.50 person-years of follow-up, 1054 children (0.7%) were diagnosed with ASD; boys with ASD outnumbered girls by a ratio of about 4:1. The mean (SD) age of children at the end of follow-up was 6.24 (3.19) years. Adjusting for potential confounders, use of antidepressants during the second and/or third trimester was associated with the risk of ASD (31 exposed infants; adjusted hazard ratio, 1.87; 95% CI, 1.15-3.04). Use of selective serotonin reuptake inhibitors during the second and/or third trimester was significantly associated with an increased risk of ASD (22 exposed infants; adjusted hazard ratio, 2.17; 95% CI, 1.20-3.93). The risk was persistent even after taking into account maternal history of depression (29 exposed infants; adjusted hazard ratio, 1.75; 95% CI, 1.03-2.97).

Conclusions and Relevance
Use of antidepressants, specifically selective serotonin reuptake inhibitors, during the second and/or third trimester increases the risk of ASD in children, even after considering maternal depression. Further research is needed to specifically assess the risk of ASD associated with antidepressant types and dosages during pregnancy.

2. Associations of Maternal Antidepressant Use During the First Trimester of Pregnancy With Preterm Birth, Small for Gestational Age, Autism Spectrum Disorder, and Attention-Deficit/Hyperactivity Disorder in Offspring

Key Points

Findings
In this retrospect cohort study of 1 580 629 Swedish offspring using multiple statistical and methodical approaches to adjust for confounding, first-trimester antidepressant exposure was significantly associated with preterm birth (odds ratio, 1.3 in a sibling comparison analysis) but not with risk of being born small for gestational age or later autism spectrum disorder or attention-deficit/hyperactivity disorder.

Meaning
After accounting for confounding factors, first-trimester antidepressant exposure, compared with no exposure, was associated with a small increased risk of preterm birth but no increased risk of small for gestational age, autism spectrum disorder, or attention-deficit/hyperactivity disorder.

2017 Abstract

Importance
Prenatal antidepressant exposure has been associated with adverse outcomes. Previous studies, however, may not have adequately accounted for confounding.

Objective
To evaluate alternative hypotheses for associations between first-trimester antidepressant exposure and birth and neurodevelopmental problems.

Design, Setting, and Participants
This retrospective cohort study included Swedish offspring born between 1996 and 2012 and followed up through 2013 or censored by death or emigration. Analyses controlling for pregnancy, maternal and paternal covariates, as well as sibling comparisons, timing of exposure comparisons, and paternal comparisons, were used to examine the associations.

Exposures
Maternal self-reported first-trimester antidepressant use and first-trimester antidepressant dispensations.

Main Outcomes and Measures
Preterm birth (< 37 gestational weeks), small for gestational age (birth weight < 2 SDs below the mean for gestational age), and first inpatient or outpatient clinical diagnosis of autism spectrum disorder and attention-deficit/hyperactivity disorder in offspring.

Results
Among 1 580 629 offspring (mean gestational age, 279 days; 48.6% female; 1.4% [n = 22 544] with maternal first-trimester self-reported antidepressant use) born to 943 776 mothers (mean age at childbirth, 30 years), 6.98% of exposed vs 4.78% of unexposed offspring were preterm, 2.54% of exposed vs 2.19% of unexposed were small for gestational age, 5.28% of exposed vs 2.14% of unexposed were diagnosed with autism spectrum disorder by age 15 years, and 12.63% of exposed vs 5.46% of unexposed were diagnosed with attention-deficit/hyperactivity disorder by age 15 years. At the population level, first-trimester exposure was associated with all outcomes compared with unexposed offspring (preterm birth odds ratio [OR], 1.47 [95% CI, 1.40-1.55]; small for gestational age OR, 1.15 [95% CI, 1.06-1.25]; autism spectrum disorder hazard ratio [HR], 2.02 [95% CI, 1.80-2.26]; attention-deficit/hyperactivity disorder HR, 2.21 [95% CI, 2.04-2.39]). However, in models that compared siblings while adjusting for pregnancy, maternal, and paternal traits, first-trimester antidepressant exposure was associated with preterm birth (OR, 1.34 [95% CI, 1.18-1.52]) but not with small for gestational age (OR, 1.01 [95% CI, 0.81-1.25]), autism spectrum disorder (HR, 0.83 [95% CI, 0.62-1.13]), or attention-deficit/hyperactivity disorder (HR, 0.99 [95% CI, 0.79-1.25]). Results from analyses assessing associations with maternal dispensations before pregnancy and with paternal first-trimester dispensations were consistent with findings from the sibling comparisons.

Conclusions and Relevance
Among offspring born in Sweden, after accounting for confounding factors, first-trimester exposure to antidepressants, compared with no exposure, was associated with a small increased risk of preterm birth but no increased risk of small for gestational age, autism spectrum disorder, or attention-deficit/hyperactivity disorder.

Image credit Jamie Campbell.

Maternal SSRI use during pregnancy risks speech/language disorders in offspring

Association of Selective Serotonin Reuptake Inhibitor Exposure During Pregnancy With Speech, Scholastic, and Motor Disorders in Offspring

Key Points

Question
Is exposure to selective serotonin reuptake inhibitors during pregnancy associated with an increased risk of adverse speech, scholastic, or motor outcomes in offspring?

Findings
In this cohort study, offspring of mothers who purchased at least 2 selective serotonin reuptake inhibitors prescriptions during pregnancy had a significantly increased risk of speech/language disorders compared with offspring of mothers diagnosed as having psychiatric disorders who did not take medication during pregnancy.

Meaning
The findings suggest that use of selective serotonin reuptake inhibitors during pregnancy increases the risk of speech/language disorders in offspring.

Abstract

Maternal SSRI use during pregnancy risks speech/language disorders in offspring, JAMA Psychiatry, October 12, 2016.

Image @JAMAPsych.

Importance
Speech/language, scholastic, and motor disorders are common in children. It is unknown whether exposure to selective serotonin reuptake inhibitors (SSRIs) during pregnancy influences susceptibility to these disorders.

Objective
To examine whether SSRI exposure during pregnancy is associated with speech/language, scholastic, and motor disorders in offspring up to early adolescence.

Design, Setting, and Participants
This prospective birth cohort study examined national population-based register data in Finland from 1996 to 2010. The sampling frame includes 845 345 pregnant women and their singleton offspring with data on maternal use of antidepressants and depression-related psychiatric disorders during pregnancy.

Exposures
There were 3 groups of offspring: 15 596 were in the SSRI-exposed group, ie, had mothers diagnosed as having depression-related psychiatric disorders with a history of purchasing SSRIs during pregnancy; 9537 were in the unmedicated group, ie, had mothers diagnosed as having depression-related psychiatric disorders without a history of purchasing SSRIs during pregnancy; and 31 207 were in the unexposed group, ie, had mothers without a psychiatric diagnosis or a history of purchasing SSRIs.

Main Outcomes and Measures
Cumulative incidence of speech/language, scholastic, or motor disorders (829, 187, and 285 instances, respectively) from birth to 14 years. All hypotheses tested were formulated before data collection.

Results
Of the 56 340 infants included in the final cohort, 28 684 (50.9%) were male and 48 782 (86.6%) were 9 years or younger. The mean (SD) ages of children at diagnosis were 4.43 (1.67), 3.55 (2.67), and 7.73 (2.38) for speech/language, scholastic, and motor disorders, respectively. Offspring of mothers who purchased SSRIs at least twice during pregnancy had a significant 37% increased risk of speech/language disorders compared with offspring in the unmedicated group. The cumulative hazard of speech/language disorders was 0.0087 in the SSRI-exposed group vs 0.0061 in the unmedicated group (hazard ratio, 1.37; 95% CI, 1.11-1.70; P = .004). There was a significantly increased risk of these disorders in offspring in the SSRI-exposed and unmedicated groups compared with offspring in the unexposed group. For scholastic and motor disorders, there were no differences between offspring in the SSRI-exposed group and in the unmedicated group.

Conclusions and Relevance
Exposure to SSRIs during pregnancy was associated with an increased risk of speech/language disorders. This finding may have implications for understanding associations between SSRIs and child development.

Brain Changes found in Newborns exposed to Antidepressants

Antidepressive treatment during pregnancy can affect newborn brain activity

A first of its kind neuroscience study, published this month in Cerebral Cortex, found changes in the brain electrical activity of infants exposed to SSRI antidepressants during pregnancy. The changes are associated with less-organized communication between the brain’s hemispheres and are comparable to the effects found in previous animal studies.

New Study Finds Brain Changes in Newborns Exposed to Antidepressants, madinamerica, June 17, 2016.

The researchers call for more critical evaluations of the prescription of antidepressants during pregnancy and suggest that non-pharmacologic and therapeutic alternatives should be the preferred treatment.

Abstract

Newborn Brain Function Is Affected by Fetal Exposure to Maternal Serotonin Reuptake Inhibitors, cercor.oxfordjournals, doi: 10.1093/cercor/bhw153, June 6, 2016.

Recent experimental animal studies have shown that fetal exposure to serotonin reuptake inhibitors (SRIs) affects brain development. Modern recording methods and advanced computational analyses of scalp electroencephalography (EEG) have opened a possibility to study if comparable changes are also observed in the human neonatal brain. We recruited mothers using SRI during pregnancy (n = 22) and controls (n = 62). Mood and anxiety of mothers, newborn neurology, and newborn cortical function (EEG) were assessed. The EEG parameters were compared between newborns exposed to drugs versus controls, followed by comparisons of newborn EEG features with maternal psychiatric assessments. Neurological assessment showed subtle abnormalities in the SRI-exposed newborns. The computational EEG analyses disclosed a reduced interhemispheric connectivity, lower cross-frequency integration, as well as reduced frontal activity at low-frequency oscillations. These effects were not related to maternal depression or anxiety. Our results suggest that antenatal serotonergic treatment might change newborn brain function in a manner compatible with the recent experimental studies.

Antidepressive treatment during pregnancy can affect newborn brain activity, University of Helsinki, 15.6.2016. Photo Sampsa Vanhatalo.

The present EEG findings suggest links at the level of neuronal activity between human studies and animal experiments. These links will also enable bidirectional translation in future studies on the neuronal mechanisms and long-term neurodevelopmental effects of early SRI exposure.

Kids Say No to Drugs

Why let pharma drug your children?

ritalin-adhd-cartoon
At present we are stoking the desire for mind-altering effects with medically authorised substances, some of which may be just as harmful or worse than their illicit counterparts.

So today we have the bizarre situation in which use of mind-altering substances is simultaneously prohibited and promoted. Taking heroin to numb the pain of life is demonised, but taking an ‘antidepressant’ or ‘mood stabiliser’ to combat your depressive tendencies or manage your mood swings is encouraged, and not just by the pharmaceutical industry, but by professional and governmental anti-stigma campaigns.

Health cartoons

Suicidality and aggression during SSRI antidepressant treatment

Systematic review and meta-analyses based on clinical study reports

Babel image
Clinical study reports for duloxetine, fluoxetine, paroxetine, sertraline, and venlafaxine obtained from the European and UK drug regulators, and summary trial reports for duloxetine and fluoxetine from Eli Lilly’s website. Antidepressant use doubles the risk of suicide in under 18s and the risks to adults may have been seriously underestimated, researchers found. Babel.

Abstract

Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports, BMJ 2016;352:i65, 27 January 2016.

Objective
To study serious harms associated with selective serotonin and serotonin-norepinephrine reuptake inhibitors.

Design
Systematic review and meta-analysis.

Main outcome measures
Mortality and suicidality. Secondary outcomes were aggressive behaviour and akathisia.

Data sources
Clinical study reports for duloxetine, fluoxetine, paroxetine, sertraline, and venlafaxine obtained from the European and UK drug regulators, and summary trial reports for duloxetine and fluoxetine from Eli Lilly’s website.

Eligibility criteria for study selection
Double blind placebo controlled trials that contained any patient narratives or individual patient listings of harms.

Data extraction and analysis
Two researchers extracted data independently; the outcomes were meta-analysed by Peto’s exact method (fixed effect model).

Results
We included 70 trials (64 381 pages of clinical study reports) with 18 526 patients. These trials had limitations in the study design and discrepancies in reporting, which may have led to serious under-reporting of harms. For example, some outcomes appeared only in individual patient listings in appendices, which we had for only 32 trials, and we did not have case report forms for any of the trials. Differences in mortality (all deaths were in adults, odds ratio 1.28, 95% confidence interval 0.40 to 4.06), suicidality (1.21, 0.84 to 1.74), and akathisia (2.04, 0.93 to 4.48) were not significant, whereas patients taking antidepressants displayed more aggressive behaviour (1.93, 1.26 to 2.95). For adults, the odds ratios were 0.81 (0.51 to 1.28) for suicidality, 1.09 (0.55 to 2.14) for aggression, and 2.00 (0.79 to 5.04) for akathisia. The corresponding values for children and adolescents were 2.39 (1.31 to 4.33), 2.79 (1.62 to 4.81), and 2.15 (0.48 to 9.65). In the summary trial reports on Eli Lilly’s website, almost all deaths were noted, but all suicidal ideation events were missing, and the information on the remaining outcomes was incomplete.

Antidepressants can raise the risk of suicide, biggest ever review finds, telegraph, 27 January 2016.

Conclusions
Because of the shortcomings identified and having only partial access to appendices with no access to case report forms, the harms could not be estimated accurately. In adults there was no significant increase in all four outcomes, but in children and adolescents the risk of suicidality and aggression doubled. To elucidate the harms reliably, access to anonymised individual patient data is needed.

Antidepressant use during Pregnancy and the Risk of Autism Spectrum Disorder in Children

Taking antidepressants during pregnancy increases risk of autism by 87 percent

Taking antidepressants during pregnancy increases risk of autism by 87 percent. Some classes of antidepressants work by inhibiting serotonin (SSRIs and some other antidepressant classes), which will have a negative impact on the ability of the brain to fully develop and adapt in utero, Scott Roberts.

2015 Study Abstract

Importance
The association between the use of antidepressants during gestation and the risk of autism spectrum disorder (ASD) in children is still controversial. The etiology of ASD remains unclear, although studies have implicated genetic predispositions, environmental risk factors, and maternal depression.

Objective
To examine the risk of ASD in children associated with antidepressant use during pregnancy according to trimester of exposure and taking into account maternal depression.

Design, Setting, and Participants
We conducted a register-based study of an ongoing population-based cohort, the Québec Pregnancy/Children Cohort, which includes data on all pregnancies and children in Québec from January 1, 1998, to December 31, 2009. A total of 145 456 singleton full-term infants born alive and whose mothers were covered by the Régie de l’assurance maladie du Québec drug plan for at least 12 months before and during pregnancy were included. Data analysis was conducted from October 1, 2014, to June 30, 2015.

Exposures
Antidepressant exposure during pregnancy was defined according to trimester and specific antidepressant classes.

Main Outcomes and Measures
Children with ASD were defined as those with at least 1 diagnosis of ASD between date of birth and last date of follow-up. Cox proportional hazards regression models were used to estimate crude and adjusted hazard ratios with 95% CIs.

Results
During 904 035.50 person-years of follow-up, 1054 children (0.7%) were diagnosed with ASD; boys with ASD outnumbered girls by a ratio of about 4:1. The mean (SD) age of children at the end of follow-up was 6.24 (3.19) years. Adjusting for potential confounders, use of antidepressants during the second and/or third trimester was associated with the risk of ASD (31 exposed infants; adjusted hazard ratio, 1.87; 95% CI, 1.15-3.04). Use of selective serotonin reuptake inhibitors during the second and/or third trimester was significantly associated with an increased risk of ASD (22 exposed infants; adjusted hazard ratio, 2.17; 95% CI, 1.20-3.93). The risk was persistent even after taking into account maternal history of depression (29 exposed infants; adjusted hazard ratio, 1.75; 95% CI, 1.03-2.97).

Conclusions and Relevance
Use of antidepressants, specifically selective serotonin reuptake inhibitors, during the second and/or third trimester increases the risk of ASD in children, even after considering maternal depression. Further research is needed to specifically assess the risk of ASD associated with antidepressant types and dosages during pregnancy.

Sources and more information
  • Antidepressant Use During Pregnancy and the Risk of Autism Spectrum Disorder in Children, JAMA Pediatrics, doi:10.1001/jamapediatrics.2015.3356, December 14, 2015.
  • Taking antidepressants during pregnancy increases risk of autism by 87 percent, medicalxpress, December 14, 2015.
  • Antidepressants during pregnancy linked to autism, medicalnewstoday, 14 December 2015.

Treatment of Symptoms of the Menopause: assessing individual Benefits, Risks of Menopausal Therapies

Experts Recommend Assessing Individual Benefits, Risks of Menopausal Therapies

Menopausal-Therapies
The Endocrine Society today issued a Clinical Practice Guideline (CPG) on identifying women who are candidates for treatment of menopausal symptoms and selecting the best treatment options for each individual.

Endocrine Society – Hormone Science to Health – press release Experts Recommend Assessing Individual Benefits, Risks of Menopausal Therapies

Washington, DC – The Clinical Practice Guideline (CPG), entitled “Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline” was published online and will appear in the November 2015 print issue of the Journal of Clinical Endocrinology and Metabolism (JCEM), a publication of the Endocrine Society.

Menopause is the life stage that takes place when a woman’s ovaries dramatically decrease production of the hormones estrogen and progesterone, and her menstrual periods stop. The average age of an American woman experiencing menopause is around 51 years old.

During menopause, many women experience symptoms such as hot flashes, night sweats, sleep disturbances, mood changes, joint pain, recurrent urinary tract infections, and difficult or painful sexual intercourse. These symptoms can start in the years before a woman’s final menstrual period and last for more than a decade.

Women now have a broader range of treatment options for menopausal symptoms than ever before, but many clinicians are reluctant to pursue them. A 2012 Endocrine Society survey found that 72 percent of women currently experiencing menopause symptoms had not received any treatment for them.

Hormone therapy—at one time the most popular treatment for menopausal symptoms— has been under intense scrutiny since 2002, when a large government study called the Women’s Health Initiative (WHI) reported that hormone therapy – specifically the combination of conjugated equine estrogens and medroxyprogesterone acetate (Prempro) – increased the risk for blood clots, stroke, breast cancer and heart attacks in postmenopausal women aged 50 to 79 years at study onset. But additional research conducted in the ensuing years indicated the level of risk depends on the individual woman’s health history, age and other factors. Experts have formed a consensus that the benefits of menopausal hormone therapy exceed the risks for most healthy women seeking relief of menopausal symptoms.

There is no need for a woman to suffer from years of debilitating menopausal symptoms, as a number of therapies, both hormonal and non-hormonal are now available,” said Cynthia A. Stuenkel, MD, the chair of the task force that authored the guideline and an endocrinologist specializing in menopause at the University of California, San Diego. “Every woman should be full partners with her health care providers in choosing whether treatment is right for her and what treatment option best suits her needs. The decision should be based on available evidence regarding the treatment’s safety and effectiveness, as well as her individual risk profile and personal preferences.

In the CPG – see full PDF – the Endocrine Society recommends that women with a uterus who decide to undergo menopausal hormone therapy with estrogen and progestogen be informed about risks and benefits, including the possible increased risk of breast cancer during and after discontinuing treatment. Health care providers should advise all women, including those taking menopausal hormone therapy, to follow guidelines for breast cancer screening.

Other recommendations from the CPG include:

  • Transdermal estrogen therapy by patch, gel or spray is recommended for women who request menopausal hormone therapy and have an increased risk of venous thromboembolism – a disease that includes deep vein thrombosis.
  • Progestogen treatment prevents uterine cancer in women taking estrogen for hot flash relief. For women who have undergone a hysterectomy, it is not necessary.
  • If a woman on menopausal hormone therapy experiences persistent unscheduled vaginal bleeding, she should be evaluated to rule out endometrial cancer or hyperplasia.
  • Medications called selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), gabapentin or pregabalin are recommended for women who want medication to manage moderate to severe hot flashes, but either prefer not to take hormone therapy or have significant risk factors that make hormone therapy inadvisable.
  • Low-dose vaginal estrogen therapy is recommended to treat women for genitourinary symptoms of menopause, such as burning and irritation of the genitalia, dryness, discomfort or pain with intercourse; and urinary urgency or recurrent infections. This treatment should only be used in women without a history of estrogen-dependent cancers.

The Hormone Health Network, the Endocrine Society’s public education arm, developed an interactive digital resource called the Menopause MapTM for women to explore the stages of menopause and learn about symptoms they may experience. The Menopause MapTM related resources are available. The Hormone Health Network also offers a digital toolkit for health care providers.

Other members of the Endocrine Society task force that developed this CPG include: Susan R. Davis of Monash University in Melbourne, Australia; Anne Gompel of the Université Paris Descartes in Paris, France; Mary Ann Lumsden of the University of Glasgow School of Medicine in Glasgow, Scotland; M. Hassan Murad of the Mayo Clinical in Rochester, MN; JoAnn V. Pinkerton of the University of Virginia in Charlottesville, VA; and Richard J. Santen of the University of Virginia Health System in Charlottesville, VA.This CPG was co-sponsored by the Australasian Menopause Society, British Menopause Society, European Society of Endocrinology and the International Menopause Society.

The Society established the CPG Program to provide endocrinologists and other clinicians with evidence-based recommendations in the diagnosis and treatment of endocrine-related conditions. Each CPG is created by a task force of topic-related experts in the field. Task forces rely on scientific reviews of the literature in the development of CPG recommendations as well as feedback from co-sponsoring societies, members of the Endocrine Society and expert reviewers. The Endocrine Society does not solicit or accept corporate support for its CPGs. All CPGs are supported entirely by Society funds. A list of CPGs can be found here.

Pain Killers in Pregnancy: Prescription Opioid Epidemic and Infant Outcomes

Opioids During Pregnancy Put Babies at Risk

infant image
Infants exposed to opioid pain relievers were more likely to experience a variety of health problems, including low birth weight. Newborns whose pregnant mothers were prescribed opioid drugs may undergo neonatal abstinence syndrome — withdrawal symptoms, essentially. Infants suffering withdrawal may experience breathing problems, convulsions, vomiting, diarrhea, high-pitched crying, poor appetite, jitteriness, tremors, sweating, fever, mottled skin, and excessive sucking or rooting. Image Will Murphy.

2015 Study Abstract

BACKGROUND AND OBJECTIVES:
Although opioid pain relievers are commonly prescribed in pregnancy, their association with neonatal outcomes is poorly described. Our objectives were to identify neonatal complications associated with antenatal opioid pain reliever exposure and to establish predictors of neonatal abstinence syndrome (NAS).

METHODS:
We used prescription and administrative data linked to vital statistics for mothers and infants enrolled in the Tennessee Medicaid program between 2009 and 2011. A random sample of NAS cases was validated by medical record review. The association of antenatal exposures with NAS was evaluated by using multivariable logistic regression, controlling for maternal and infant characteristics.

RESULTS:
Of 112 029 pregnant women, 31 354 (28%) filled ≥1 opioid prescription. Women prescribed opioid pain relievers were more likely than those not prescribed opioids (P < .001) to have depression (5.3% vs 2.7%), anxiety disorder (4.3% vs 1.6%) and to smoke tobacco (41.8% vs 25.8%). Infants with NAS and opioid-exposed infants were more likely than unexposed infants to be born at a low birth weight (21.2% vs 11.8% vs 9.9%; P < .001). In a multivariable model, higher cumulative opioid exposure for short-acting preparations (P < .001), opioid type (P < .001), number of daily cigarettes smoked (P < .001), and selective serotonin reuptake inhibitor use (odds ratio: 2.08 [95% confidence interval: 1.67–2.60]) were associated with greater risk of developing NAS.

CONCLUSIONS:
Prescription opioid use in pregnancy is common and strongly associated with neonatal complications. Antenatal cumulative prescription opioid exposure, opioid type, tobacco use, and selective serotonin reuptake inhibitor use increase the risk of NAS.

Sources and More Information
  • Pill-pushing doctors endanger babies by prescribing opioid painkillers to pregnant women, naturalnews, August 15, 2015.
  • Prescription Opioid Epidemic and Infant Outcomes, American Academy of Pediatrics, (doi: 10.1542/peds.2014-3299), February 10, 2015.
  • Drug addict babies: Common pregnancy pain drugs leave newborns suffering horrific withdrawal symptoms, mirror, 14 April 2015.
  • Opioids During Pregnancy Put Babies at Risk, medpagetoday, 04.13.2015.
  • Pregnant Women Prescribed Opioids Have Babies More Likely To Suffer Complications, Withdrawal Symptoms, medicaldaily, Apr 14, 2015.