February 9

Safety of Newborn infants Threatened by Rx antidepressants during pregnancy

This appears to be an effort to put out a firestorm in the wake of the latest in a series of published reports about the hazardous effects antidepressants have on newborn infants whose mothers ingested them during pregnancy.

A report in The New England Journal of Medicine found that the use of SSRIs in pregnancy poses a serious risk of pulmonary hypertension in newborns.  The condition that "is associated with substantial infant mortality and morbidity." "Despite treatment, 10 to 20 percent of affected infants will not survive." 

The demonstrable hazards of these widely prescribed drugs refute a decade of physicians’ assurances about the safety of "selective serotonin reuptake inhibitors." These antidepressants are neither selective nor safe as they affect neurological, metabolic, hormonal, and respiratory body systems.  The scientific evidence is pilling up against the use of these drugs—especially when prescribed for children and pregnant women.

SSRIs pose potentially lethal hazards for unborn, developing infants in 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 newborns GREATER harm than infants who suffered withdrawal symptoms due to their mothers’ crack cocaine habit.

Yet, the NEJM study author, Dr. Christine Chambers considers a 1 in 100 risk of fatal pulmonary hypertension—a “low” risk for infants:
 "It’s very important to get across that we don’t know for certain that the drugs actually caused persistent pulmonary hypertension, and that if they did, the risk is still low, about one in a hundred," said the new study’s lead author,
This is but a demonstration of the muddled thinking that afflicts psychiatry’s academics—most of whom are under the spell of drug industry “beneficence.”

For example, it is disclosed that two of the authors of a JAMA report earlier this month, which did not look at risks for infants, but rather at relapse rates—without considering  drug withdrawal symptoms that are often misdiagnosed as relapse. That study concluded that fewer women relapse on drugs than if they stopped taking them. 

However, the study’s conclusion is suspect inasmuch as industry’s influence is not absent:  “The National Institute of Mental Health funded this study. Two of the authors have disclosed various financial relationships with GlaxoSmithKline, Lilly, Pfizer, Wyeth, and/or Bristol-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 the mounting body count, that deaths attributed to Vioxx were not “real deaths.”  She is quoted stating; “this isn’t a cause for panic.  For many women, the small risk suggested by this study may be outweighed by their own personal need for treatment of a mental health condition."

Thus, industry’s profit margins override the value judgments made by America’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 and psychiatry’s institutional leadership has derailed the profession from its responsibility toward patients’ best interests.
Indeed this unholy alliance has succeeded in saturating the information channels with false and misleading drug infomercials targeting both the public and treating doctors. Industry has widely broadcast false assurances by psychiatry’s key opinion leaders who misstated the facts about safety.  They bear equal responsibility for the widespread misprescribing of antidepressants–even during pregnancy. 

See a series of articles, mostly by the same authors who put a positive 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 antidepressants for pregnant depressed women, but recommends these drugs as "prophylactic treatment:"

"Given the apparent safety of antidepressants and the possible adverse effects of untreated depression, is prophylactic treatment warranted during pregnancy and the postpartum period?
For women with a significant history of depression, the answer may be yes. "   http://neuropsychiatryreviews.com/jun01/npr_jun01_antidepressants.html

Psychiatry ought to be held accountable for making false claims about drug safety. There ought to be a law prohibiting licensed professionals from prescribing hazrdous substances to pregnanct women and children–without even informing them about the documented risks the drugs pose.

Even an examination of the risks disclosed by manufacturers in these drugs’ labels should have raised alarm bells about widespread prescribing of antidepressants–especially for children and pregnant women whose intake of toxic substances injures their yet to be born infants.  

To make an informed decision, one must weigh the potential benefits against the risks. To do so, one must know what the relative risks are.
See: https://ahrp.org/cms/content/view/71/28/

For those unaware about the risks listed in the labels of these drugs–risks that were documented in controlled clinical trials, see the following Adverse Event tables for the most widely prescribed SSRIs–Prozac, Paxil and Zoloft. The adverse events (A-E) listed in these drugs’ labels show those A-Es that were reported during clinical trials.
The Tables show the relative risk (% of A-E) in patients taking one of these drugs compared to the relative risk for those on placebo.

We compiled a Table using the risk information disclosed in these drugs’ labels. Our table shows the adverse events that are listed for any of these drugs in tables of adverse events (contained in the drugs’ label) for which the risk was greater for patients receiving the drug than for patients receiving placebo.   That is, the table shows the excess risk (%) of the drug over and above the background risk that occurred with placebo.
See: Benefits and Risks of SSRIs Above and Beyond Placebo: Demonstrated in Short-Term Controlled Clinical Trials  https://ahrp.org/risks/SSRIrbTable.html
We also show the drugs’ claimed benefit for depressed children–as calculated by a Task Force of the American College of Neuropsychopharmacology–from pediatric trials in depressed children.  Of note, ACNP members conducted many of the SSRI trials both before their approval and post-marketing studies. See: ACNP Task Force Report on 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 to help physicians and parents to evaluate the benefit / risk ratio that these drugs present for children and adolescents.

However, as news reports continue to disclose additional serious risks–particularly risks for children and infants—risk reassessments will, no doubt, be needed to ascertain the true overall risks posed by psychoactive prescription drugs.

Contact: Vera Hassner Sharav

New England Journal of Medicine Volume 354:579-587     February 9, 2006
Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary 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.

Background Persistent pulmonary hypertension of the newborn (PPHN) is associated with substantial infant mortality and morbidity. A previous cohort study suggested a possible association between maternal use of the selective serotonin-reuptake inhibitor (SSRI) fluoxetine late in the third trimester of pregnancy and the risk of PPHN in the infant. We performed a case–control study to assess whether PPHN is associated with exposure to SSRIs during late pregnancy.

Methods Between 1998 and 2003, we enrolled 377 women whose infants had PPHN and 836 matched control women and their infants. Maternal interviews were conducted by nurses, who were blinded to the study hypothesis, regarding medication use in pregnancy and potential confounders, including demographic variables and health history.

Results Fourteen infants with PPHN had been exposed to an SSRI after the completion of the 20th week of gestation, as compared with six control infants (adjusted odds ratio, 6.1; 95 percent confidence interval, 2.2 to 16.8). In contrast, neither the use of SSRIs before the 20th week of gestation nor the use of non-SSRI antidepressant drugs at any time during pregnancy was associated with an increased risk of PPHN.

Conclusions These data support an association between the maternal use of SSRIs in late pregnancy and PPHN in the offspring; further study of this association is warranted. These findings should be taken into account in decisions as to whether to continue the use of SSRIs during pregnancy.

Source Information

From the Departments of Pediatrics (C.D.C., K.L.J.) and Family and Preventive Medicine (C.D.C.), University of California, San Diego, La Jolla; the Slone Epidemiology Center, Boston University School of Public Health, Boston (S.H.-D., M.M.W., C.L., A.A.M.); and Children’s Hospital and Brigham and Women’s Hospital, Harvard Medical School, Boston (L.J.V.M.).

Address reprint requests to Dr. Chambers at the University of California, San Diego, Medical Center, 200 W. Arbor Dr., Mail Code 8446, San Diego, CA 92103, or at chchambers@ucsd.edu .

The New England Journal of Medicine is owned, published, and copyrighted © 2006 Massachusetts Medical Society <http://www.massmed.org/> . All rights reserved.

FDA considers new warning on labels of antidepressants
The Boston Globe – February 09, 2006

Feb. 9–WASHINGTON — The Food and Drug Administration is again considering revising labels of popular antidepressants, this time in response to an article in today’s New England Journal of Medicine that linked use of drugs like Paxil, Prozac, and Zoloft late in pregnancy with a condition that can endanger infants’ lives.

During a hastily called press conference yesterday, the FDA called the results 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. Its regulatory options include updating drug labels, searching public and private 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 the newborn — is rare and failure to treat maternal depression can cause its own problems, the study’s lead author does not expect the FDA to follow the lead of Canadian regulators, who warned against using new-generation antidepressants during pregnancy.

In October 2004, the FDA told manufacturers to add warnings on boxes alerting patients that the antidepressants increase suicidal thoughts and behaviors in children taking them. Last December it warned of an association between Paxil and heart defects when the drug is taken early in pregnancies.

The study described in the Journal article was observational and included interviews with 1,200 women within six months of giving birth. It is unethical to give pregnant women experimental drugs to gauge birth defect risks.
"This is an approach to looking at all medications that pregnant women might take and doing it in a systematic, consistent fashion so that we don’t wait years to find out if a drug might cause a problem," said Christina Chambers, the study’s lead author and director of a California program that fields 8,000 calls annually about the safety of medicines for developing fetuses.

Up to 15 percent of women of reproductive age suffer major depressive disorders. The study focused on new-generation antidepressants called selective serotonin reuptake inhibitors. They were the nation’s fifth highest selling class of prescription drugs in the first nine months of 2005, accounting for 122.6 million prescriptions, according to IMS Health a pharmaceutical market research firm. About 3 percent of women take that type of antidepressant at some point during pregnancy.

Normally, one to two newborns per 1,000 suffer from persistent pulmonary hypertension, which means their pulmonary arterial pressure is too high at birth. As a result, their lungs can’t provide enough oxygen, causing their bodies to produce oxygen-poor blood and sometimes resulting in death. In one study, nearly half the survivors were cognitively delayed, had major neurological problems, and could not hear.

When pregnant women took selective serotonin reuptake inhibitors after 20 weeks gestation, the risk of their infants developing persistent pulmonary hypertension rose sixfold, to about one in 100 newborns. The study size was too small to determine whether one antidepressant was riskier than another.  "This is the latest in a series of troubling reports of possible adverse events" of selective serotonin reuptake inhibitors on fetuses, Dr. James Mills of the National Institutes of Health wrote in an accompanying editorial in the Journal.

Previous studies linked the antidepressants with infants’ rapid breathing, 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 medication without consulting both their obstetricians and doctors providing their mental healthcare.  "This isn’t a cause for panic," the FDA’s Kweder said. "The risk is small enough that 99 percent of women’s babies who are taking these medicines would not be at risk."

To see more of The Boston Globe, or to subscribe to the newspaper, go to http://www.boston.com/globe.  Copyright (c) 2006, The Boston Globe
Distributed by Knight Ridder/Tribune Business News.

February 9, 2006
Antidepressants May Harm Infants’ Lungs, Report Says

Expectant mothers who took antidepressants like Prozac late in their pregnancy  likely to give birth to an infant with a rare but serious breathing problem, doctors are reporting today. The lung disorder, called persistent pulmonary hypertension, strikes 1 to 2 newborns in 1,000, on average, and can be fatal. In babies exposed to antidepressants during the last few months of pregnancy, the study found, the rate was six times as high: 6 to 12 newborns in 1,000.

In a news conference yesterday, Dr. Sandra L. Kweder, an official at the Food and Drug Administration, which was not involved in the research, said that the study results were "very worrisome," and that the agency planned to search its own database of adverse events for further evidence of risk. She said the F.D.A. would consider whether to require manufacturers to make labeling changes and conduct postmarketing 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 choices that face millions of women with depression who are pregnant or plan to be. Untreated maternal depression can also harm a developing fetus, experts say, and last week researchers reported in a study that 68 percent 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 to antidepressants in the womb suffer temporary withdrawal symptoms like agitation. The F.D.A. has warned that one popular depression drug, Paxil, from GlaxoSmithKline, may increase the risk of rare heart problems in newborns exposed to the medication in utero.
"It’s very important to get across that we don’t know for certain that the drugs actually caused persistent pulmonary hypertension, and that if they did, the risk is still low, about one in a hundred," said the new study’s lead author, Dr. Christine Chambers, an assistant professor of pediatrics  at the University of California, San Diego, who worked with researchers from Boston University and Harvard. "But women should be informed."

Psychiatrists estimate that 10 percent to 15 percent of pregnant women suffer bouts of depression, and at least 1 in 10 of those take antidepressants. Between 1998 and 2003, the research team interviewed 377 women who had recently given birth to a baby with persistent pulmonary hypertension, asking about medical history and drugs taken during pregnancy. The researchers found that 3.7 percent of the infants had been exposed to commonly prescribed antidepressants after the 20th week of pregnancy, about six times the rate among infants in a comparison group of healthy babies born at the same time.

The antidepressants belong to a class of drugs that acts in the brain to prolong the action of a mood-related messenger chemical called serotonin. 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 the body’s production of agents that help blood vessels dilate. If the vessels in a newborn’s lungs do not open properly, they cannot absorb sufficient 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 that doctors may connect an affected child to an artificial lung.

Obstetricians, psychiatrists and pediatricians agree that pregnant women taking the drugs should consult their doctors to decide how to proceed. Stopping antidepressant therapy can cause withdrawal effects as well as relapse, they say.

Dr. Timothy Oberlander, a developmental pediatrician at the University of British Columbia, said that the new study added to a small but growing literature that was helping clarify the risks of specific drugs taken during pregnancy.
"You’re talking about small numbers here, but it’s clear that there are a group of babies that have more side-effects from exposure to these drugs than most," Dr. Oberlander said, "and women need to weigh this against the risk of untreated depression, which not only affects the mother but the context in which the child is raised."

Copyright 2006 The New York Times Company
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