Safety of Newborn Babies Threatened by SSRIs Rx during pregnancy

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[sSRI-Research] Safety of Newborn Babies Threatened by SSRIsRx during pregnancy Safety of Newborn Babies Threatened by SSRIs Rx during pregnancy ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)Promoting Openness, Full Disclosure, and Accountabilitywww.ahrp.org FYIThe Boston Globe reports (below) that "During a hastily called pressconference yesterday," the FDA announced that it is consideringADDITIONAL warnings on the labels of SSRI drugs-Prozac, Paxil, Zoloft,et al. This appears to be an effort to put out a firestorm in thewake of the latest in a series of published reports about thehazardous effects antidepressants have on newborn infants whosemothers ingested them during pregnancy.A report in The New England Journal of Medicine found that the use ofSSRIs in pregnancy poses a serious risk of pulmonary hypertension innewborns. The condition that "is associated with substantial infant mortalityand morbidity.Despite treatment, 10 to 20 percent of affectedinfants will not survive." The demonstrable hazards of these widely prescribed drugs refute adecade of physicians' assurances about the safety of "selectiveserotonin reuptake inhibitors." These antidepressants are neitherselective nor safe as they affect neurological, metabolic, hormonal,and respiratory body systems. The scientific evidence is pilling upagainst the use of these drugs-especially when prescribed for childrenand pregnant women. SSRIs pose potentially lethal hazards for unborn, developing infantsin the womb--and 30% suffer withdrawal symptoms. It is becoming more and more evident that doctors--many unwittingly,others knowingly-- are prescribing drugs that cause MORE newbornsGREATER harm than infants who suffered withdrawal symptoms due totheir mothers' crack cocaine habit. Yet, the NEJM study author, Dr. Christine Chambers considers a 1 in100 risk of fatal pulmonary hypertension-a "low" risk for infants: "It's very important to get across that we don't know for certain thatthe drugs actually caused persistent pulmonary hypertension, and thatif they did, the risk is still low, about one in a hundred," said thenew study's lead author, This is but a demonstration of the muddled thinking that afflictspsychiatry's academics-most of whom are under the spell of drugindustry "beneficence." For example, it is disclosed that two of the authors of a JAMA reportearlier this month, which did not look at risks for infants, butrather at relapse rates-without considering drug withdrawal symptomsthat are often misdiagnosed as relapse. That study concluded thatfewer women relapse on drugs than if they stopped taking them. However, the study's conclusion is suspect inasmuch as industry'sinfluence is not absent: "The National Institute of Mental Healthfunded this study. Two of the authors have disclosed various financialrelationships with GlaxoSmithKline, Lilly, Pfizer, Wyeth, and/orBristol-Myers Squibb." Along these same lines, was the response of a high FDA official, Dr.Sandra Kweder, who defended the safety of Vioxx in the midst of themounting body count, that deaths attributed to Vioxx were not "realdeaths." She is quoted stating; "this isn't a cause for panic. Formany women, the small risk suggested by this study may be outweighedby their own personal need for treatment of a mental health condition." Thus, industry's profit margins override the value judgments made byAmerica's medical elite-- medicine's precautionary first principle;"First, do no harm," has been banished from the risk/ benefit equation. To paraphrase the late truly ethical, responsible psychiatrist, Dr.Loren Mosher, an unholy alliance between drug manufacturers andpsychiatry's institutional leadership has derailed the profession fromits responsibility toward patients' best interests. Indeed this unholy alliance has succeeded in saturating theinformation channels with false and misleading drug infomercialstargeting both the public and treating doctors. Industry has widelybroadcast false assurances by psychiatry's key opinion leaders whomisstated the facts about safety. They bear equal responsibility forthe widespread misprescribing of antidepressants--even during pregnancy. See a series of articles, mostly by the same authors who put apositive spin on medical malpractice: JAMA:http://jama.ama-assn.org/cgi/search?fulltext==wisner & submit.x==0 & submit.y==0 & submit==GO; American Psychiatric Association not only recommends antidepressantsfor pregnant depressed women, but recommends these drugs as"prophylactic treatment:Given the apparent safety of antidepressants and the possible adverseeffects of untreated depression, is prophylactic treatment warrantedduring pregnancy and the postpartum period? For women with a significant history of depression, the answer may beyes. " http://neuropsychiatryreviews.com/jun01/npr_jun01_antidepressants.html Psychiatry ought to be held accountable for making false claims aboutdrug safety. There ought to be a law prohibiting licensedprofessionals from prescribing hazrdous substances to pregnanct womenand children--without even informing them about the documented risksthe drugs pose. Even an examination of the risks disclosed by manufacturers in thesedrugs' labels should have raised alarm bells about widespreadprescribing of antidepressants--especially for children and pregnantwomen whose intake of toxic substances injures their yet to be borninfants. To make an informed decision, one must weigh the potential benefitsagainst the risks. To do so, one must know what the relative risks are. See: http://www.ahrp.org/cms/content/view/71/28/ For those unaware about the risks listed in the labels of thesedrugs--risks that were documented in controlled clinical trials, seethe following Adverse Event tables for the most widely prescribedSSRIs--Prozac, Paxil and Zoloft. The adverse events (A-E) listed inthese drugs' labels show those A-Es that were reported during clinicaltrials. The Tables show the relative risk (% of A-E) in patients taking one ofthese drugs compared to the relative risk for those on placebo. We compiled a Table using the risk information disclosed in thesedrugs' labels. Our table shows the adverse events that are listed forany of these drugs in tables of adverse events (contained in thedrugs' label) for which the risk was greater for patients receivingthe drug than for patients receiving placebo. That is, the tableshows the excess risk (%) of the drug over and above the backgroundrisk that occurred with placebo. See: Benefits and Risks of SSRIs Above and Beyond Placebo:Demonstrated in Short-Term Controlled Clinical Trials http://ahrp.org/risks/SSRIrbTable.html We also show the drugs' claimed benefit for depressed children--ascalculated by a Task Force of the American College ofNeuropsychopharmacology--from pediatric trials in depressed children. Of note, ACNP members conducted many of the SSRI trials both beforetheir approval and post-marketing studies. See: ACNP Task Force Reporton SSRIs and Suicidal Behavior in Youth (2005)http://www.nature.com/npp/journal/vaop/ncurrent/full/1300958a.html We hope that our table provides information not otherwise available tohelp physicians and parents to evaluate the benefit / risk ratio thatthese drugs present for children and adolescents. However, as news reports continue to disclose additional seriousrisks--particularly risks for children and infants-risk reassessmentswill, no doubt, be needed to ascertain the true overall risks posed bypsychoactive prescription drugs. Contact: Vera Hassner Sharav212-595-8974veracare < http://content.nejm.org/content/vol354/issue6/index.shtml> New England Journal of Medicine Volume 354:579-587 February 9, 2006Selective Serotonin-Reuptake Inhibitors and Risk of PersistentPulmonary Hypertension of the Newborn Christina D. Chambers, Ph.D., M.P.H., Sonia Hernandez-Diaz, M.D.,Dr.P.H., Linda J. Van Marter, M.D., M.P.H., Martha M. Werler, Sc.D.,Carol Louik, Sc.D., Kenneth Lyons Jones, M.D., and Allen A. Mitchell, M.D. ABSTRACT Background Persistent pulmonary hypertension of the newborn (PPHN) isassociated with substantial infant mortality and morbidity. A previouscohort study suggested a possible association between maternal use ofthe selective serotonin-reuptake inhibitor (SSRI) fluoxetine late inthe third trimester of pregnancy and the risk of PPHN in the infant.We performed a case-control study to assess whether PPHN is associatedwith exposure to SSRIs during late pregnancy. Methods Between 1998 and 2003, we enrolled 377 women whose infants hadPPHN and 836 matched control women and their infants. Maternalinterviews were conducted by nurses, who were blinded to the studyhypothesis, regarding medication use in pregnancy and potentialconfounders, including demographic variables and health history. Results Fourteen infants with PPHN had been exposed to an SSRI afterthe completion of the 20th week of gestation, as compared with sixcontrol infants (adjusted odds ratio, 6.1; 95 percent confidenceinterval, 2.2 to 16.8). In contrast, neither the use of SSRIs beforethe 20th week of gestation nor the use of non-SSRI antidepressantdrugs at any time during pregnancy was associated with an increasedrisk of PPHN. Conclusions These data support an association between the maternal useof SSRIs in late pregnancy and PPHN in the offspring; further study ofthis association is warranted. These findings should be taken intoaccount in decisions as to whether to continue the use of SSRIs duringpregnancy. Source Information From the Departments of Pediatrics (C.D.C., K.L.J.) and Family andPreventive Medicine (C.D.C.), University of California, San Diego, LaJolla; the Slone Epidemiology Center, Boston University School ofPublic Health, Boston (S.H.-D., M.M.W., C.L., A.A.M.); and Children'sHospital and Brigham and Women's Hospital, Harvard Medical School,Boston (L.J.V.M.). Address reprint requests to Dr. Chambers at the University ofCalifornia, San Diego, Medical Center, 200 W. Arbor Dr., Mail Code8446, San Diego, CA 92103, or at chchambers . The New England Journal of Medicine is owned, published, andcopyrighted © 2006 Massachusetts Medical Society< http://www.massmed.org/> . All rights reserved. ~~~~~~~~~~~~~ http://www.psycport.com/stories/knightridder_2006_02_09_krtbn_0000-0017-GL-ANTIDEPRESS-20060209.xml.htmlFDA considers new warning on labels of antidepressantsThe Boston Globe - February 09, 2006Feb. 9--WASHINGTON -- The Food and Drug Administration is againconsidering revising labels of popular antidepressants, this time inresponse to an article in today's New England Journal of Medicine thatlinked use of drugs like Paxil, Prozac, and Zoloft late in pregnancywith a condition that can endanger infants' lives. During a hastily called press conference yesterday, the FDA called theresults of a study cited in the article "very concerning." The agency will issue a public health advisory within days, said Dr.Sandra Kweder, deputy director of the FDA's Office of New Drugs. Itsregulatory options include updating drug labels, searching public andprivate databases to corroborate the drug link to the lung condition,and requiring additional trials from drug manufacturers. But because the condition -- persistent pulmonary hypertension of thenewborn -- is rare and failure to treat maternal depression can causeits own problems, the study's lead author does not expect the FDA tofollow the lead of Canadian regulators, who warned against usingnew-generation antidepressants during pregnancy. In October 2004, the FDA told manufacturers to add warnings on boxesalerting patients that the antidepressants increase suicidal thoughtsand behaviors in children taking them. Last December it warned of anassociation between Paxil and heart defects when the drug is takenearly in pregnancies. The study described in the Journal article was observational andincluded interviews with 1,200 women within six months of givingbirth. It is unethical to give pregnant women experimental drugs togauge birth defect risks. "This is an approach to looking at all medications that pregnant womenmight take and doing it in a systematic, consistent fashion so that wedon't wait years to find out if a drug might cause a problem," saidChristina Chambers, the study's lead author and director of aCalifornia program that fields 8,000 calls annually about the safetyof medicines for developing fetuses. Up to 15 percent of women of reproductive age suffer major depressivedisorders. The study focused on new-generation antidepressants calledselective serotonin reuptake inhibitors. They were the nation's fifthhighest selling class of prescription drugs in the first nine monthsof 2005, accounting for 122.6 million prescriptions, according to IMSHealth a pharmaceutical market research firm. About 3 percent of womentake that type of antidepressant at some point during pregnancy. Normally, one to two newborns per 1,000 suffer from persistentpulmonary hypertension, which means their pulmonary arterial pressureis too high at birth. As a result, their lungs can't provide enoughoxygen, causing their bodies to produce oxygen-poor blood andsometimes resulting in death. In one study, nearly half the survivorswere cognitively delayed, had major neurological problems, and couldnot hear. When pregnant women took selective serotonin reuptake inhibitors after20 weeks gestation, the risk of their infants developing persistentpulmonary hypertension rose sixfold, to about one in 100 newborns. Thestudy size was too small to determine whether one antidepressant wasriskier than another. "This is the latest in a series of troublingreports of possible adverse events" of selective serotonin reuptakeinhibitors on fetuses, Dr. James Mills of the National Institutes ofHealth wrote in an accompanying editorial in the Journal. Previous studies linked the antidepressants with infants' rapidbreathing, jitteriness, bluish skin color from lack of oxygen,difficulty nursing, and low blood sugar. The FDA said it does not want pregnant women to stop medicationwithout consulting both their obstetricians and doctors providingtheir mental healthcare. "This isn't a cause for panic," the FDA'sKweder said. "The risk is small enough that 99 percent of women'sbabies who are taking these medicines would not be at risk." To see more of The Boston Globe, or to to the newspaper, goto http://www.boston.com/globe. Copyright © 2006, The Boston Globe Distributed by Knight Ridder/Tribune Business News. http://www.nytimes.com/2006/02/09/national/09depress.html?ex=40152400 & en=¢309f2b552af81e & ei=P70 & emc==eta1THE NEW YORK TIMESFebruary 9, 2006Antidepressants May Harm Infants' Lungs, Report SaysBy BENEDICT CAREYExpectant mothers who took antidepressants like Prozac late in theirpregnancy were significantly more likely to give birth to an infantwith a rare but serious breathing problem, doctors are reporting today. The lung disorder, called persistent pulmonary hypertension, strikes 1to 2 newborns in 1,000, on average, and can be fatal. In babiesexposed to antidepressants during the last few months of pregnancy,the study found, the rate was six times as high: 6 to 12 newborns in1,000. In a news conference yesterday, Dr. Sandra L. Kweder, an official atthe Food and Drug Administration, which was not involved in theresearch, said that the study results were "very worrisome," and thatthe agency planned to search its own database of adverse events forfurther evidence of risk. She said the F.D.A. would consider whetherto require manufacturers to make labeling changes and conductpostmarketing studies to clarify the risk. The findings, published today in The New England Journal of Medicine,are the latest in a series of reports that highlight the tough choicesthat face millions of women with depression who are pregnant or planto be. Untreated maternal depression can also harm a developing fetus,experts say, and last week researchers reported in a study that 68percent of pregnant women who quit taking antidepressants relapsed,compared with 26 percent of those who stayed on the drugs. But studies have found that up to one-third of babies exposed toantidepressants in the womb suffer temporary withdrawal symptoms likeagitation. The F.D.A. has warned that one popular depression drug,Paxil, from GlaxoSmithKline, may increase the risk of rare heartproblems in newborns exposed to the medication in utero. "It's very important to get across that we don't know for certain thatthe drugs actually caused persistent pulmonary hypertension, and thatif they did, the risk is still low, about one in a hundred," said thenew study's lead author, Dr. Christine Chambers, an assistantprofessor of pediatrics at the University of California, San Diego,who worked with researchers from Boston University and Harvard. "Butwomen should be informed." Psychiatrists estimate that 10 percent to 15 percent of pregnant womensuffer bouts of depression, and at least 1 in 10 of those takeantidepressants. Between 1998 and 2003, the research team interviewed377 women who had recently given birth to a baby with persistentpulmonary hypertension, asking about medical history and drugs takenduring pregnancy. The researchers found that 3.7 percent of theinfants had been exposed to commonly prescribed antidepressants afterthe 20th week of pregnancy, about six times the rate among infants ina comparison group of healthy babies born at the same time. The antidepressants belong to a class of drugs that acts in the brainto prolong the action of a mood-related messenger chemical calledserotonin. They included Celexa, from Forest Laboratories; Zoloft,from Pfizer; Paxil; and Prozac, from Eli Lilly. In their paper, the researchers argue that the drugs may hinder thebody's production of agents that help blood vessels dilate. If thevessels in a newborn's lungs do not open properly, they cannot absorbsufficient oxygen, and the body may reflexively hold its breath,further starving itself of air, doctors say. Giving an infant oxygen,or nitric oxide, which helps open vessels, often relieves the problem.An estimated 10 percent to 20 percent of cases are severe enough thatdoctors may connect an affected child to an artificial lung. Obstetricians, psychiatrists and pediatricians agree that pregnantwomen taking the drugs should consult their doctors to decide how toproceed. Stopping antidepressant therapy can cause withdrawal effectsas well as relapse, they say. Dr. Timothy Oberlander, a developmental pediatrician at the Universityof British Columbia, said that the new study added to a small butgrowing literature that was helping clarify the risks of specificdrugs taken during pregnancy. "You're talking about small numbers here, but it's clear that thereare a group of babies that have more side-effects from exposure tothese drugs than most," Dr. Oberlander said, "and women need to weighthis against the risk of untreated depression, which not only affectsthe mother but the context in which the child is raised." Copyright 2006The New York Times Company FAIR USE NOTICE: This may contain copyrighted (© ) material the use ofwhich has not always been specifically authorized by the copyrightowner. Such material is made available for educational purposes, toadvance understanding of human rights, democracy, scientific, moral,ethical, and social justice issues, etc. It is believed that thisconstitutes a 'fair use' of any such copyrighted material as providedfor in Title 17 U.S.C. section 107 of the US Copyright Law. Thismaterial is distributed without profit.