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This presentation details a risk/benefit analyis of the use of SSRIs during pregnancy and concludes that the risks far outweigh the benefits. SSRIs are no more effective than placebo and carry a large …

This presentation details a risk/benefit analyis of the use of SSRIs during pregnancy and concludes that the risks far outweigh the benefits. SSRIs are no more effective than placebo and carry a large cummulative risk for birth complcations. No first use of psychiatric drugs is advocated.

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  • Now Marcia will offer concluding remarks.
  • Transcript

    • 1. The Use and Abuse of Psychiatric Drugs
      Barry Duncan, Psy.D.
      Marcia Barbacki
    • 2.
    • 3. Women During Child Bearing Years
      MDD affects b/w 7% & 13%, peak age 25-44
      BD affects b/w 4% & 6%, with onset in the teens to early 20s.
      Schizophrenia affects about 1% during the early childbearing years.
    • 4. Prevalence of SSRIsUsed During Pregnancy in the US
      Between 14% and 23% of pregnant women experience depressive symptoms, and approximately 13% of women in 2003 took an antidepressant at some time during pregnancy.
    • 5. Global Prevalence of SSRIsUsed During Pregnancy
      13% in the US
      5% in Canada
      Increases in Finland, Denmark, Israel, Germany, and Italy
      Global increase of psych meds: 274%
    • 6. What Is the Evidence Regarding Efficacy and Safety?
      No RCTs w/pregnant women, so all use is off-label
      Have to rely on RCTs about meds in general pop. & on studies of the incidence of birth defects to address:
    • 7. Are Increasing Rates Justified by a Risk Benefit Analysis?
      More importantly, what should you, as physicians and health care professionals, know to conduct an informed discussion about treatments for emotional and behavioral problems during pregnancy?
    • 8. Justified by the Clinical Trial Evidence?
      Hard to Get an Accurate Picture
      Marcia Angell: “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly & reluctantly over my two decades as an editor of NEJM.”
    • 9. Pharmaceutical Company InfluenceIt’s Everywhere, It’s Everywhere
      Extends to Internet, print, & broadcast media, direct-to consumer-advertising, “grassroots” consumer-advocacy, prof. guilds, medical schools, docs, & research—even the FDA. So, press reports, web pages, & even academic literature can be unreliable.
    • 10. Compounding the ProblemFront Line Physicians Don’t Have
      Time, ed., & training to eval. clin. trial lit. or options.
      Result is over-reliance on meds as a first-line tx & under-reliance on safer, comparably effective psychosocial options.
      Inconsistent findings; method. problems, recall, selection bias, confounds; here most recent, sound, replicated findings
    • 11. First, The SSRI RCT LiteratureAre They Effective?
      Kirsch et al. (2008) & Fournier et al. (2010) meta-analytically examined available SSRI trials & found no differences between placebo & SSRIs, for mild, mod. or severe depression w/exception of the most distressed in severely depressed group.
      The negligible advantage over placebo underlines the importance of their substantial adverse effects, including suicidal behavior and the birth defects to be discussed.
    • 12. Other Antidepressant Data
      STAR*D: Largest SSRI trial: 108 of 4,041 who entered the trial remitted & stayed well to the FU period. 97% failed to remit, relapsed or dropped out
      Rush et al. (2011): 1 SSRI produced same remission as 2 SSRIS at 12 weeks & 7 months but 2 produced sig. more adverse events.
    • 13. FDA Pregnancy Safety RatingsA, B, C, D, & X
      Category A: controlled studies show no fetal risks associated with the drug;
      Category B: no evidence of risk in humans, risks have been noted in animal studies;
      Category C: risk cannot be ruled out;
      Category D: positive evidence of risk; and
      Category X: contraindicated for use in pregnancy.
      No SSRI has an A or B rating
    • 14.
    • 15. Finland: ObstetGynecol(6976;2011)Cardiovascular Malformations
      Fluoxetine: 2-fold increase for ventricular septal defects; paroxetine: 4-fold for right ventricular outflow tract defects (0.5% for unexposed to .9% for SSRI to 2.1% for 2 SSRIs)
    • 16. SSRIs: Israel, Italy, GermanyBritish J. of Clin Pharmacology(2008)
      2191 pregnant women — 410 paroxetine and 314 fluoxetine in the first trimester of pregnancy and 1467 controls.
      2-fold increased risk in rate of congenital anomalies with SSRIs compared w/controls, cardiovascular anomalies most common.
      Heart anomalies: 2.8% in the fluoxetine group, 2% in the paroxetine group, and 0.6% in the control group
    • 17. More from the British Journal of Clinical Pharmacology
      Previous pregnancy terminations (spontaneous abortion) were also higher in the fluoxetine & paroxetine groups compared with controls, with rates of 7.8%, 4.8%, and 2.8%. Birth weights were lower in the fluoxetine & paroxetine groups than control group.
    • 18. Prenatal Antidepressant Exposure Syndrome
      Exposure in the 3rd trimester related to embryotoxicity or poor neonatal adaptation: tremor, feeding difficulties, irritability, agitation, rigidity, and respiratory distress.
      FDA and Health Canada warnings 
    • 19. 2006 FDA Warning
      Use of SSRIs past 20th week of pregnancy linked to a 6-fold increase in risk for persistent pulmonary hypertension (PPHN) in newborns
    • 20. Spontaneous AbortionCanadian Study: CMAJ (5124;2010)
      Use of SSRIs was associated with a 68% increased risk of spontaneous abortion.
      Use of more than one class of antidepressant doubled the risk of spontaneous abortion
    • 21. Preterm Birth, Apgar, ICU Admits Denmark Study: Arch of Ped & Adol Med
      Infants of mothers who took SSRIs during pregnancy at greater risk for preterm birth, a low 5-minute Apgar score, and admission to the neonatal intensive care unit.
    • 22. Rates of AutismArch of Gen Psychiatry (1800; 2011)
      Autism: increased from 4 to 5 per 10,000 (1966) to almost 100 today.
      Children whose mothers took an SSRI 1 yr prior to birth had 2X rate of ASD.
      Children whose mothers took an SSRI during pregnancy had 3x the rate.
    • 23. Findings Showing Increased RiskWhat the “Experts” Say
      “Need to balance the small risks of SSRIs against those of no tx.”
      “Only 3 times the risk. The general risk is 1%. So that means the risk is still just 3%.”
      “No epidemiologic study can prove a risk, but if there is one, it appears to be low.”
      “Important to interpret data in the context of the deleterious effects of untreated depression.”
    • 24. Taking a Closer LookThe Mantra of:
      Meds pose only a small risk
      Untreated depression has deleterious effects
    • 25. How Many Risks Are Enough?
      1. 2x the rate of cardiovascular malformations
      2. 6x the rate of persistent pulmonary hypertension (and other withdrawal problems)
      3. 68% higher rate of spontaneous abortion
      4. Significantly more preterm births, lower Apgar scores, and ICU admissions
      5. 2 or 3x the rate of autism
      6. Gestational hypertension: Over 2x the risk (9 v. 19%)
      7. Combined with the lack of efficacy and general adverse effect package of SSRIs
      The Cumulative Risk
      Is Significant
    • 26. The Myth of Untreated DepressionUnderlying Illness, not the SSRIs
      “Treated depression” doesn’t yield good results in RCTs
      3 studies above compared depressed women who used SSRIs v. depressed women who didn’t: The Denmark, Canadian, and US studies found no effects of “untreated depression” on the fetus or newborn.
    • 27. Recent Meta-Analytic Study Looked at PRB, LBW, IUGR
      Depression ??; 2/3 didn’t control for SSRI use
      Depressed women from US middle class or from a social democracy did not have birth defects; only impoverished countries or poor in the US; much stronger argument re poverty than untreated depression
    • 28. The Evidence Warrants A Serious Look&Changes in Prescribing Practices
      We warn about alcohol & cigarettes, but how much evidence do we need to warn about psychiatric medications?
    • 29. Psychosocial Options First Find Alternatives in Your Area
      Alternatives should be discussed: Stress reduction techniques, support groups, psychotherapy, reducing work hours, familial, Church, & community support.
      Many women express concerns about medication during pregnancy & physicians must offer alternatives
    • 30. In the Case of DepressionPsychological Treatments in RCTs
      Are as effective as medication in the short run with more durable benefits in the long run, even if the depression is severe
      Although combined treatments are touted as the best option, they are not better than psychotherapy alone over the long term but they have better results than medication alone
    • 31. A Call for A Higher Standard of CareDuncan & Antonuccio (2011)
      1). Informed consent and a risk/benefit analysis
      2). Psychosocial intervention
      first—find alternatives
      3). Avoid polypharmacy or other non-
      empirically supported practices
      4). Monitor treatment response with
      patient rated measures
      5). Making Data Accessible
      6). Separate industry influence from science and practice
    • 32. Pope Benedict XVI, Nov., 2006
      “Scientific predictability also raises the question of the scientists’ ethical responsibilities. His conclusions must be guided by respect for the truth & honest acknowledgement of both the accuracy & the inevitable limitations of the scientific method. Certainly this means avoiding needlessly alarming predictions when these are not supported by sufficient data or exceeds science’s actual ability to predict. But it also means avoiding the opposite, namely a silence born of fear, in the face of genuine problems. The influence of scientists in shaping public opinion is too important to be undermined by undue haste or the pursuit of superficial publicity.”
    • 33. Conclusions The Evidence Speaks the Truth
      When clinical trials are examined & risks considered, the evidence does not support SSRIs as a first treatment for pregnant women.
      Knowing that there is no compelling evidence to medicate, providers must discuss the risks/benefits & alternatives: Church, community, counseling to help women make choices that honor values, culture, & spirituality.
      Bottom Line: Look at the evidence yourself and draw your own conclusions
    • 34. The ChurchIn Addition to Spiritual Leadership
      Has a rich history of benefiting humanity, comforting the frail and disenfranchised, protecting the sanctity of human life, and strengthening families. The Church may be the only power on earth that can counter the forces of corporate greed that have no moral or ethical conscience.