Posts Tagged ‘Heart defects’

New Study: Antidepressants Linked to Birth Defects

Monday, September 28th, 2009

Salynn Boyles
WebMD Health News
September 24, 2009

New research adds to the evidence that babies born to women who take antidepressants  during pregnancy have a small increased risk for a specific heart defect.

The Danish study also shows that the risk is greatest when moms-to-be take more than one selective serotonin reuptake inhibitor (SSRI) antidepressant or switch SSRIs early in pregnancy.

SSRIs such as Prozac, Paxil, Zoloft, Celexa and Lexapro are the most widely prescribed drugs for depression; millions of women take them during pregnancy.

The new study shows the overall risk for congenital heart problems associated with SSRI to be quite low.

But babies born to women who had filled prescriptions for more than one SSRI had a fourfold increase in septal heart defects — a malformation of the wall that divides the left and right sides of the heart.

Read entire article: http://www.webmd.com/baby/news/20090924/antidepressants-linked-to-birth-defect

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Judge orders Glaxo to provide emails between it and researchers regarding Paxil-birth defect connection.

Thursday, September 17th, 2009

Newsinferno
September 17, 2009

Pharmaceutical giant GlaxoSmithKline Plc has been making news in recent days over issues with its blockbuster antidepressant medication Paxil and allegations the drug is linked to birth defects when taken by pregnant women. Worse, new claims are emerging of a cover-up in which Glaxo knew of the dangerous side effects, but buried the information.

In one of two ongoing cases being heard, the family of William Seale—who died in 2004 allegedly as a result of heart defects caused by Paxil, said Fierce Pharma—is suing Glaxo. William’s mother was taking Paxil when pregnant with William and the family alleges that Glaxo knew of Paxil’s risks, yet attempted to have researchers position results to benefit the company and avoid legal actions, said Fierce Pharma.

Now, reports Fierce Pharma, a judge has mandated Glaxo provide emails between it and researchers who were looking into the Paxil-birth defect connection. U.S. District Judge Nancy Gertner in Boston ruled “the plaintiffs are entitled to correspondence and documents between anyone at Slone and GSK about the study, its scope” and methodology, quoted Fierce Pharma, citing Bloomberg.

Read entire article: http://www.newsinferno.com/archives/12325

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On trial – Did drug giant GlaxoSmithKline know Paxil could cause birth defects more than 20 years ago?

Wednesday, September 16th, 2009

Jef Feeley and Margaret Cronin Fisk
Bloomberg.com
September 16, 2009

Sept. 15 (Bloomberg) — An executive of GlaxoSmithKline, 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.

The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up 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.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Kilker’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son.

Read entire article: http://www.bloomberg.com/apps/news?pid=20601087&sid=ah9mMl9sDitg

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