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Birth Defects
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By atracyphd on May 1, 2010
In December 2005, GlaxoSmithKline (GSK) posted its Paxil findings on its
website regarding pregnant women taking antidepressants. In this announcement,
GSK noted that it was revising its pregnancy precaution category from C to D.
This revision was based on recent studies that indicated positive evidence of
human fetal risk. In addition, GSK was placing this information in the WARNINGS
section of the Paxil label.
The FDA then advised pregnant women to switch from Paxil to another SSRI
drug, such as Prozac or Zoloft. This warning was based on the results of an
analysis of Sweden’s birth registry that showed women who took Paxil were 1.5 to
Posted in Recent Cases Blog | Tagged Adverse Effects, Antidepressant, antidepressants, Birth Defects, Birth Registry, Dr Ann, Drug Awareness, Drugawareness, Fetal Risk, GlaxoSmithKline, Gsk, Heart Defects, International Coalition, Paxil, Paxil Birth Defects, Pregnant Women, Selective Serotonin Reuptake Inhibitors, Selective Serotonin Reuptake Inhibitors Ssris, Serotonin Reuptake Inhibitors, Third Month Of Pregnancy |
By atracyphd on January 26, 2010
According to a new study accepted for publication in The Endocrine Society’s
Journal of Clinical Endocrinology & Metabolism (JCEM), women
taking commonly used forms of antidepressant drugs may experience delayed
lactation after giving birth and may need additional support to achieve their
breastfeeding goals.
Breastfeeding benefits both infants and mothers in many ways as breast milk
is easy to digest and contains antibodies that can protect infants from
bacterial and viral infections. The World Health Organization recommends that
infants should be exclusively breastfed for the first six months of life. This
new study shows that certain common antidepressant drugs may be linked to a
common difficulty experienced by new mothers known as delayed secretory
activation, defined as a delay in the initiation of full milk secretion.
“The breasts are serotonin-regulated glands, meaning the breasts’ ability to
secrete milk at the right time is closely related to the body’s production and
regulation of the hormone serotonin,” said Nelson Horseman, PhD, of the
University of Cincinnati and co-author of the study. “Common antidepressant
drugs like fluoxetine, sertraline and paroxetine are known as selective
serotonin reuptake inhibitor (SSRI) drugs and while they can affect mood,
emotion and sleep they may also impact serotonin regulation in the breast,
placing new mothers at greater risk of a delay in the establishment of a full
milk supply.”
Posted in Recent Cases Blog | Tagged Antibodies, antidepressants, Benefit From, Best Interest, Birth Defects, Breast Milk, Breastfeeding Benefits, Breastmilk, Cold Turkey, Contaminated Milk, Dr. Tracy, Drugawareness, drugs, Family Physician, Horrific Birth Defects, Lactation, Mom, Pediatrician, Prozac, Viral Infections, World Health Organization |
By atracyphd on October 13, 2009
GlaxoSmithKline P.L.C. must pay $2.5 million to settle a
claim that its Paxil antidepressant caused severe heart defects in a
3-year-old Bensalem boy, a Philadelphia common pleas jury ruled
today.
The verdict is the first in 600 cases alleging that
London-based Glaxo knew Paxil caused birth defects and hid those risks to
boost profits.
The drug, approved for U.S. use in 1992, generated about $942
million in sales last year, 2.1 percent of Glaxo’s total
revenue.
Posted in Recent Cases Blog | Tagged 5 Million, 5m, Birth Defects, Glaxo, GlaxoSmithKline, Heart Defects, Inquirer Staff Writer, Live Births, Medication, Miriam, Paxil, Paxil Antidepressant, Paxil Pregnancy, Philadelphia Common Pleas, Philadelphia Firm, Philadelphia Region, Profits, Regulators, Sheller, Tue Oct |
By atracyphd on October 8, 2009
GlaxoSmithKline P.L.C., the world’s second-biggest drugmaker, begins a trial in Philadelphia next week in what may be a test case for more than 600 lawsuits over claims that the company’s antidepressant drug Paxil causes birth defects.
Patients and their parents say internal company documents show Glaxo failed to warn consumers about the risks of Paxil until forced to do so in 2005 by the Food and Drug Administration. In the trial set to start Monday, Michelle David blames the drug for causing life-threatening heart defects in her son, Lyam Kilker, now age 3.
Posted in Recent Cases Blog | Tagged Antidepressant Drug, Birth Defects, Bloomberg News, Cronin, David Logan, Drug Paxil, Food And Drug, Food And Drug Administration, Glaxo, GlaxoSmithKline, Global Settlement, Heart Defects, Inquirer Business, Internal Company Documents, Margaret Cronin Fisk, Paxil, Paxil Birth Defects, Roger Williams University, Settlement Negotiations, Test Case, Test Cases |
By atracyphd on September 26, 2009
NEW YORK (Reuters Health) – If you take antidepressants such as fluoxetine (marketed as Prozac) early in your pregnancy, you may be doubling the risk that your newborn will be born with a heart defect, according to a new study.
However, the vast majority of children born to women who take such antidepressants – known as selective serotonin reuptake inhibitors (SSRIs) – do not have such defects, the researchers are quick to note.
Earlier studies have tied SSRIs during pregnancy to heart defects, but also to even more serious birth defects. According to the new study of nearly half a million children born in Denmark between 1996 and 2003, however, only heart defects are likely to be associated with the antidepressants, note co-author Dr. Lars Henning Pedersen, from Aarhus University, Denmark, and colleagues.
Posted in Recent Cases Blog | Tagged antidepressants, Birth Defects, Cital, Disability Payments, Dr. Tracy, Drugawareness, Early Pregnancy, Fetus, Fluoxetine, Heart Birth Defects, Heart Defect, Heart Defects, Insurance Rates, Many Mothers, Medical Treatment, Nursing Mothers, Open Heart Surgery, Paxil, Reconstructive Surgeries, Risk, Sertraline, Transposition Of The Great Arteries, Zoloft |
By atracyphd on September 15, 2009
Sept. 15 (Bloomberg) — An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.
“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.
Posted in Recent Cases Blog | Tagged Animal Studies, Antidepressant Drug, Birth Defects, Church Congregation, Company Memo, Cronin, Dr. Tracy, Drug Paxil, Glaxo, GlaxoSmithKline, Glaxosmithkline Plc, Heart Defects, Heart Surgery, Jef, Margaret Cronin Fisk, Opening Statements, Paxil, Philadelphia Trial, Prozac, Rossello |
By retoddb on April 13, 2001
Birth defects in the babies of women who take medicine for epilepsy while
they are pregnant are caused by the drugs and not by the epilepsy, according
to new research reported in the US.
Posted in DrugAwareness.org Newsletters | Tagged Birth Defects, Dr Ann, Drug Awareness, England Journal of Medicine, Health Editor, International Coalition, Jeffrey Dahmer, Journal Of Medicine, Mild Seizure, New England Journal, New England Journal of Medicine, Omega 3 Oils, Rate Of Birth, Retarded Development, Sarah Boseley, Seizure Activity, Seizure Meds, Simple Alternatives, Toxic Solutions, Uk Archive |
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