April 20, 2024

International Coalition for Drug Awareness

A Group of physicians, researchers, Journalists and concerned citizens dedicated to educating about the dangers posed by many Rx medicines.

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ICFDA Warning

Heart Defects

Understanding Paxil Birth Defects

Ann Blake-Tracy06 mins

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

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SSRI Birth Defects: Glaxo must pay $2.5M in Paxil case

Ann Blake-Tracy05 mins

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.

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PAXIL: BIRTH DEFECTS – TEST CASE FOR OVER 600 MORE CASES – USA

Ann Blake-Tracy05 mins

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.

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SSRI: 100-500% Increased Risk of Heart Birth Defects If Taken In Early Pregnancy

Ann Blake-Tracy08 mins

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.

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PAXIL TRIAL: Glaxo Executive’s Memo Suggested Burying Drug Studies (Update4)

Ann Blake-Tracy013 mins

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.

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