Women Not Warned About SSRI-Related Lung Birth Defects
By Evelyn Pringle
October 2, 2007
A study of nearly 500,000 women by researchers at the University of Pittsburgh Medical Center, in the September 18, 2007, Annals of Internal Medicine, found that nearly 50% of women taking a prescription drug that could cause birth defects did not receive warnings to avoid pregnancy. The authors note that the pregnancy risks of a drug should be discussed with women before they begin taking it.
Experts say the seriousness of a life-threatening lung disorder found six times more often in infants born to mothers who take antidepressants during pregnancy is not being adequately conveyed to women while they are considering whether to use the drugs.
The disorder, persistent pulmonary hypertension (PPHN), occurs when a newborn does not adjust to breathing outside the womb. PPHN refers to high pressure in the lungs’ blood vessels which prevents the body’s oxygen-poor blood from entering the lungs to absorb oxygen, and leaves the infant with not enough oxygen into the bloodstream.
On July 19, 2006, the FDA ordered a PPHN warning for the labels of the selective serotonin reuptake inhibitor antidepressants (SSRI’s), based on a February 9, 2006 study in the New England Journal of Medicine, and issued a Public Health Advisory that stated:
“A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRI’s) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy.”
Two week later on August 1, 2006, the American College of Obstetricians and Gynecologist issued a press release warning that the use of SSRI’s and selective norepinephrine reuptake inhibitors (SNRI’s) during pregnancy should be individualized based on their respective risks and benefits, and specifically warned that Paxil should be avoided due to the potential risk of fetal heart defects, PPHN and other negative effects.
SSRI’s sold in the US include Paxil marketed by GlaxoSmithKline, Prozac by Eli Lilly, Zoloft by Pfizer, and Celexa and Lexapro sold by Forest Laboratories, along with various generic versions of the drugs. The closely-related class of SNRI antidepressants also carry birth defects warnings and include Wyeth’s Effexor and Lilly’s Cymbalta.
In any given year in the US, at least eighty-thousand pregnant women are prescribed SSRI’s, according to a study in the May 2005, Journal of American Medical Association. The CDC recently reported that antidepressants were the most prescribed class of drugs in the country in 2005. The fact that the overall prescribing rate is higher than for any other drugs indicates that a large number of pregnant women may be taking antidepressants without knowledge of the risks to the unborn fetus.
Overall, respiratory failure affects nearly 80,000 newborns per year, and it is responsible for as many as half of all infant deaths. Nearly one-third of all newborns with respiratory failure are born at term or near-term, and are at risk for PPHN, according to the April 2007 article, “Pulmonary Hypertension, Persistent-Newborn,” by Dr Robin Steinhorn, head of the Division of Neonatology at Children’s Memorial Hospital in Chicago and Professor at Northwestern University Medical School, in eMedicine from WebMD.
Dr Steinhorn also notes that an increased incidence of PPHN is reported for mothers who use SSRI’s during the last half of their pregnancies.
As recently as 15 years ago, the reports says, the mortality rate for PPHN infants reached 40%, and the prevalence of major neurologic disability was 15-60%. However, the introduction of extracorporeal membrane oxygenation (ECMO) and other new therapies has had a major effect on reducing the mortality rate, yet the prevalence of major neurologic disabilities among surviving newborns remains approximately 15-20%.
Dr Steinhorn reports that Glass and colleagues compared the neurodevelopmental outcome of 103 neonates following ECMO and 37 without ECMO at age 5 and states:
“Major disability, which was defined as mental disability, motor disability, sensorineural impairment, or seizure disorder, was present in 17 of children in whom ECMO had been used. The mean full-scale, verbal, and performance intelligence quotient (IQ) scores of children who received ECMO treatment were within the normal range; however, as a group, the scores were significantly lower than in children who had not had ECMO (96 vs 115).”
According to the report, infants who survive following ECMO have a higher rate of re-hospitalization for non-pulmonary and surgical conditions, and the rate of sensorineural disabilities in infants who survive averages 6% and developmental delay occurs in 9%.
Because the prevalence of hearing loss is high, the report recommends that an automated hearing test should be administered before discharging the baby and hearing should be reassessed when he or she is 6-months-old and again, as the results indicate.
Dr Steinhorn also notes that an increased frequency of social problems, academic difficulties at school age and higher rates of attention deficit disorder are reported in children who received ECMO.
Although the actual FDA warning about PPHN was not added to the antidepressant labels until August 2006, the drug makers were well aware of the risk of this birth defect for more than a decade, due to a long and steady line of studies that linked the drugs to serious respiratory problems in newborns dating back to 1996.
A study in the October 3, 1996, New England Journal of Medicine, lead by Dr Christina Chambers of the Department of Pediatrics at the University of California-San Diego, reported that PPHN developed in 2.7% of a group of infants whose mothers took Prozac throughout their pregnancy.
From 1989 through 1995, the California Teratogen Information Service and Clinical Research Program received approximately 1,500 calls requesting information on the potential teratogenic effects of Prozac (fluoxetine), and an estimated one-third of the calls were made by pregnant women who were currently taking Prozac.
For their study, the researchers selected 228 of these women. Because they hypothesized that birth size, gestational age, and neonatal adaptation were influenced by exposure to Prozac late in pregnancy, the women were divided into two groups.
One group was referred to as the exposed-early group because the women discontinued Prozac in the first or second trimester, and another group was referred to as the exposed-late group because the women continued to take Prozac in the third trimester.
A third group of 254 pregnant women who called the same California Information Program between 1989 through 1995, but with questions about other drugs and procedures that were not considered teratogenic, was enrolled as a control group.
The researchers determined that 73 infants in the exposed-late group had higher rates of premature delivery, admissions to special care nurseries, and poor neonatal adaptation, including respiratory difficulty, cyanosis on feeding and jitteriness. Birth weight was also lower and birth length shorter in the exposed-late infants, they found.
The study authors noted their concern over the 15.5% incidence of three or more minor anomalies in some infants exposed to Prozac in early pregnancy. “The combination of any three minor anomalies in a single child is an unusual finding,” they wrote.
The 15.5 percent incidence, they said, indicates that exposure during the first trimester has an effect on embryonic development. “This finding raises the possibility of an associated defect in the development of the central nervous system that may become evident when the infant is older,” the authors wrote.
In January 1998, a study in the international journal of medical science and practice, The Lancet, explained that the lungs act as a reservoir for antidepressants and this study suggests that SSRI’s could play a pivotal role in infant respiratory conditions, such as PPHN. Another study, in the April 2002 Journal of Laboratory and Clinical Medicine, investigated the effects of SSRI’s on pulmonary circulation and found that SSRI’s affect the pulmonary smooth muscle cells and aggravate pulmonary hypertension.
In June 2004, a study in Prescrire International also reported that newborns exposed to SSRI’s toward the end of pregnancy showed signs of altered muscle tone, breathing and suction problems, and agitation, with an estimated 20% to 30% of the infants affected.
The next month, after receiving hundreds of adverse event reports over a decade, in July 2004, the FDA finally revised the labels for all SSRI’s and SNRI’s, warning that some newborns exposed to the drugs had developed problems requiring prolonged hospitalizations, respiratory support and tube feeding.
Less than a year later, a study in the May 2005 Journal of the American Medical Association reported that women who took SSRI’s or SNRI’s late in pregnancy were at a 3 times higher risk of giving birth to infants suffering from serious respiratory problems, jitteriness and irritability. Lead author, Dr Eydie Moses-Kolko, reported that serious respiratory problems developed in about one out of every 100 infants.
According to Dr David Healy, a leading expert on pharmacology and author of “The Antidepressant Era,” the doctors who prescribe SSRI’s are often not able to spend enough time with patients to discuss their emotional issues in depth. “For some doctors,” he notes, “SSRI’s may appear to provide a quick solution for patient problems arising from normal life events such as bereavement, work stress, or marital conflict.”
However, he says, a review of the actual SSRI studies shows that only one patient in 10 responds to these drugs, and he attributes the massive prescribing to successful marketing rather than benefits.
“Through educational and marketing campaigns,” Dr Healy says, “the SSRI makers have produced a situation where people who would never have been given an antidepressant in the 1960s, 1970s and 1980s, are now given one after cursory questioning by a physician.”
Another leading expert, Dr Peter Breggin, founder of The International Center for the Study of Psychiatry and Psychology (ICSPP), a nonprofit research and educational network, and the journal Ethical Human Sciences and Services, also says a thorough review of all the studies submitted to the FDA for the approval of the SSRI’s showed that, when taken as a whole, the drugs do not work.
Dr Breggin also agrees that the high rate of prescribing to women indicates that women who may be experiencing minor symptoms of distress common with daily living are being convinced that they have a mental illness that requires drugs, most frequently an SSRI.
Proponents for the drug makers claim that depression itself poses a greater risk to the fetus than SSRI’s. “The problem with this claim is that there is no consideration for the health of the baby and the immense stress a mother has to endure when her baby is sick,” states Kate Gillespie, a Paxil injury lawyer from the Baum Hedlund law firm.
“Not to mention, the far greater stress that is created by having to constantly deal with life and death health issues, like the respiratory problems of an infant, that are caused by SSRI-induced PPHN,” she adds.
“For these women,” Ms Gillespie says, “it is clear that the risks far outweigh any benefit.”
An August 2006 study in the Archives of General Psychiatry compared babies born to depressed mothers treated with SSRI’s to those born to mothers who were not treated, and found a significantly greater incidence of respiratory distress, 13.9% vs 7.8%, and longer hospital stays for the infants exposed to SSRI’s.
Another study, in the August 2007 American Journal of Psychiatry, examined the effects of depression and antidepressant use on fetal age and the risk of preterm birth with 90 women and found the drugs, rather than depression, to be associated with lower fetal age and an increased risk of preterm birth. The researchers noted that the presence of depression per se during pregnancy did not adversely affect outcomes.
According to Dr Breggin, SSRI’s should never be used during pregnancy. “If pregnant women feel anxious or sad,” he says, “they should seek counseling or family therapy involving the child’s father, along with other sources of emotional support.”
Families seeking legal advice regarding SSRI-antidepressant birth defects can contact the Baum, Hedlund, Aristei & Goldman Law Firm at: (800) 827-0087 ; http://www.baumhedlundlaw.com/
(Written by Evelyn Pringle as part of the Antidepressant Birth Defect Litigation Monthly Round-Up, Sponsored by Baum Hedlund’s Pharmaceutical Antidepressant Litigation Department)
www.paxilbirthdefect.com/
www.pphnlawyers.com
(Evelyn Pringle is a regular columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America)
This morning, tech giant Microsoft Corporation will tell America that health
technology CAN protect privacy and ensure informed consent when they announce
the launch of HealthVault, an electronic health record system. Patient
Privacy Rights founder, Dr. Deborah Peel, will be standing with Microsoft to
talk about HealthVault’s privacy protections.
Microsoft has sought advice from Patient Privacy Rights about building privacy
protections into HealthVault. Today, the bar for privacy in electronic health
records has been raised exponentially: guaranteeing informed consent is NOT a
nuisance or impossibility BUT a requirement. We challenge other technology
companies to also give patients real control of their personal health
information.
Why would Patient Privacy Rights support an electronic health record?
* HealthVault requires consumers to give informed consent before any use or
disclosure of personal health information. No one: not insurers, employers,
hospitals, application partners, advertisers, data miners, or even Microsoft
will be able to access consumers’ electronic health accounts without consent.
* Microsoft has committed to independent third party audits to verify their
pledge to protect privacy.
* Microsoft is the first major multinational technology corporation to
collaborate with Patient Privacy Rights and use the 2007 Privacy Principles
created by the bi-partisan Coalition for Patient Privacy as the basis for the
consumer controls of health data stored in HealthVault.
* Microsoft’s application partners are held to the same privacy standards as
HealthVault.
* Advertisers are contractually required to protect any data transferred from
HealthVault.
* HealthVault’s privacy policies are simple and easy to understand.
* Microsoft’s new health search engine is not data mined and allows people to
search for health information anonymously.
While Microsoft assured Patient Privacy Rights that HealthVault’s privacy
protections are solid, no one should feel pressured to use HealthVault, or any
other electronic health record. You and you alone should have the right to
decide whether you are comfortable storing and sharing your health information
To learn more you can read Patient Privacy Rights’ Press Release and explore
Microsoft’s HealthVault.
Source: Ashley Katz
Patient Privacy Rights.org
Natural Solutions Foundation Media Release
www.GlobalHealthFreedom.org
GeneralStubblebine@GlobalHealthFreedom.org
Protecting Health Freedom for Consumers and Entrepreneurs
1. While health care reformers want a more educated health care consumer, FDA seeks to further stifle health information. FDA has issued a Guidance prohibiting the making of any Health Claims that lack “Significant Scientific Agreement,” an impossible standard since “significant” and “agreement” cannot be defined. Under a policy of “Harmonization,” as well as a published preference for international over domestic rulemaking (Federal Register, October 11, 1995), FDA’s own Head of Dietary Supplements Office convinced an international body, the UN-sponsored Codex Alimentarius, to prohibit as “advertising” any food related health benefit information that can change consumer behavior. Congress should pass HR 2117, the “Health Freedom Protection Act,” to allow “common law”claims and follow Supreme Court decisions, empowering consumers with helpful information on food and supplements.2. While these same health reformers want to expand access, FDA is threatening supply with another FDA Guidance, on “Complementary and Alternative Medicine” (CAM), which creates new categories of “medicine”, services and products not authorized by Congress. By using the word “Medicine” instead of “Modalities,” FDA is setting up natural therapies for a takeover by the world of licensed physicians. FDA’s intent here was made clear in March, 2007, when, after the Michigan Cherry Growers Association published scientific evidence of the healing benefits of cherries for arthritis, FDA forced the removal of that information under threat forbidding cherries as an “untested drug.” Since state medical boards often forbid natural therapies as outside the scope of medical practice, licensees who engage in such modalities could lose their licenses; lack of insurance coverage for natural modalities further will further restrict their availability. Congress should hold hearings on FDA’s attack on the natural therapies industry.
3. With a pending recession threatening jobs, FDA is poised to put manufacturers of natural therapies out of business. FDA’s own Economic Impact analysis of its dietary supplement “Good Manufacturing Practices” (GMPs) showed “establishments with not only high costs, but also average costs, could be hard pressed to continue to operate…Very small businesses with less than 20 employees will be at risk of going out of business.” Supplement manufactures already are facing cruel surprise invasions by FDA inspectors dedicated to a “strong enforcement policy” (www.fda.gov/oc/whitepapers/enforce.html). Congress should divest the FDA of “food regulation”, adding an independent Inspector General and a consumer ombudsman to protect the US food supply.4. In an FDA Revitalization bill pending Conference, the Senate version seeks to reform food regulation in response to complaints about Chinese import dangers. Section 608 would exempt from this food proposal supplements which as “food” are generally considered safe under the 1994 Dietary Supplement Health Education Act (DSHEA). Any final FDA Reform bill should retain Section 608.
HON. RON PAUL OF TEXAS
Before the U.S. House of Representatives
May 2, 2007
Introducing the Health Freedom Protection Act
Madam Speaker, I rise to introduce the Health Freedom Protection Act. This bill restores the First Amendment rights of consumers to receive truthful information regarding the benefits of foods and dietary supplements by codifying the First Amendment standards used by federal courts to strike down the Food and Drug Administration (FDA) efforts to censor truthful health claims. The Health Freedom Protection Act also stops the Federal Trade Commissions (FTC) from censoring truthful health care claims.
The American people have made it clear they do not want the federal government to interfere with their access to dietary supplements, yet the FDA and the FTC continue to engage in heavy-handed attempts to restrict such access. The FDA continues to frustrate consumers’ efforts to learn how they can improve their health even after Congress, responding to a record number of constituents’ comments, passed the Dietary Supplement and Health and Education Act of 1994 (DSHEA). FDA bureaucrats are so determined to frustrate consumers’ access to truthful information that they are even evading their duty to comply with four federal court decisions vindicating consumers’ First Amendment rights to discover the health benefits of foods and dietary supplements.
FDA bureaucrats have even refused to abide by the DSHEA section allowing the public to have access to scientific articles and publications regarding the role of nutrients in protecting against diseases by claiming that every article concerning this topic is evidence of intent to sell a drug.
Because of the FDA’s censorship of truthful health claims, millions of Americans may suffer with diseases and other health care problems they may have avoided by using dietary supplements. For example, the FDA prohibited consumers from learning how folic acid reduces the risk of neural tube defects for four years after the Centers for Disease Control and Prevention recommended every woman of childbearing age take folic acid supplements to reduce neural tube defects. This FDA action contributed to an estimated 10,000 cases of preventable neutral tube defects!
The FDA also continues to prohibit consumers from learning about the scientific evidence that glucosamine and chondroitin sulfate are effective in the treatment of osteoarthritis; that omega-3 fatty acids may reduce the risk of sudden death heart attack; and that calcium may reduce the risk of bone fractures.
The Health Freedom Protection Act will force the FDA to at last comply with the commands of Congress, the First Amendment, and the American people by codifying the First Amendment standards adopted by the federal courts. Specifically, the Health Freedom Protection Act stops the FDA from censoring truthful claims about the curative, mitigative, or preventative effects of dietary supplements, and adopts the federal court’s suggested use of disclaimers as an alternative to censorship. The Health Freedom Protection Act also stops the FDA from prohibiting the distribution of scientific articles and publications regarding the role of nutrients in protecting against disease.
This legislation also addresses the FTC’s violations of the First Amendment. Under traditional First Amendment jurisprudence, the federal government bears the burden of proving an advertising statement false before censoring that statement. However, the FTC has reversed the standard in the case of dietary supplements by requiring supplement manufactures to satisfy an unobtainable standard of proof that their statement is true. The FTC’s standards are blocking innovation in the marketplace.
The Health Freedom Protection Act requires the government bear the burden of proving that speech could be censored. This is how it should be in a free, dynamic society. The bill also requires that the FTC warn parties that their advertising is false and give them a chance to correct their mistakes.
Madam Speaker, if we are serious about putting people in charge of their health care, then shouldn’t we stop federal bureaucrats from preventing Americans from learning about simple ways to improve their health. I therefore call on my colleagues to stand up for good health care and the First Amendment by cosponsoring the Health Freedom Protection Act.
Ralph Fucetola. whose website is www.VitaminLawyer.com, writes a blog on issues pertaining to health freedom and regulatory issues. Here is Ralph’s articulate and important commentary on the absurd position of Von Eschenbach, the drug company darling running the FDA and allowing dangerous drugs to flood the market and poison Americans by the hundreds of thousands (or more: adverse reactions are notoriously under-reported).
Here is his latest blog/newsletter on Von Eschenbach ‘s dangerous dereliction of the FDA’s responsibility to the American people:
SPECIAL VLUeM – 05.31.07 – VITAMIN LAWYER UPDATE e-MEMO
PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin
Lawyer and Vitamin Lawyer News web sites for my contacts and client list.
Please take a look at www.vitaminlawyer.com – we have a new look and better
indexing. Private, privileged & confidential…——————————————————–
Ron Paul’s Bill is the answer to the FDA’s failings…
Head of FDA wants to work more closely with Drug Companies…
Report from Gardner Harris – “May 30 – When Dr. Andrew C. von Eschenbach took
over the Food and Drug Administration in 2005, the agency had a crisis over
drug approvals that had missed or ignored dangerous side effects in Vioxx,
antidepressants and other prominent medications. Dr. von Eschenbach promised
improvements, and agency officials said they would no longer be caught
flatfooted on drug safety. But this month, The New England Journal of Medicine
published a study suggesting that a major diabetes pill, Avandia, might
increase the risk of heart attacks.Concerns over that drug and others have led Republicans and Democrats in the
House and the Senate to call for investigations. A House hearing is planned
for June 6. Dr. von Eschenbach said in a briefing on Wednesday that his agency
needed to collaborate more closely with drug companies.’The point is that we need to look at the role of the F.D.A. in being a
bridge to the future, not a barrier to the future,’ he said at his office
here.”My question: is working closely with Drug Companies the solution… or the
problem?I suggest that a better solution would be promoting natural remedies without
dangerous side effects; not putting up bureaucratic barriers to them. This
can best be done by allowing people access to truthful information about
traditional, non-drug approaches; by letting natural product purveyors make
serious health claims… exactly what Ron Paul’s Health Freedom Protection Act
would do.In the twelve hours since www.globalhealthfreedom.org sent an email blast
seeking support for the Paul bill over 10,000 people have written their
congresspeople supporting the bill! We still need hundreds of thousands to
move Congress.[Note:
Here’s where to do it: http://tinyurl.com/3xwmjm orProtect our herbs, vitamins, minerals and natural remedies from bureaucratic
meddling!!
Spread the word. Ron Paul’s bill should either be passed as written or passed as an amendment to the House version of the bill that makes the FDA even more of a threat to life and liberty than it is now, Kennedy’s S. 1082 (passed May 9 with only one dissenting vote). Tell your Representatives that is what you want! Click here to direct them to protect your right to know what dietary supplements actually do for you.
The FDA is bound and determined to make that knowledge a crime, thus killing the market for dietary supplements by the efforts of the poison press (including Dr. Sanjay Gupta’s illogical, slanted and destructive article in the May 24, 2007 issue of Time Magazine) and the seductive, but equally dangerous and misleading advertising of drugs for every possible state of human experience.
If you have not already watched the “Nutricide” lecture on our home page, please do so now. It will change your life. Then get involved in making sure that everyone you know gets involved, too. That’s how we will protect our health freedom.
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org