AboutLawSuits.com – June 27, 2011

According to Finnish researchers, doctors should avoid prescribing Paxil or Prozac to pregnant women, due to the potential risk of heart birth defects.

In a study published in Obstetrics & Gynecology medical journal, researchers found that side effects of Prozac and Paxil use during pregnancy may increase the risk of women giving birth to children with congenital heart defects. Both drugs belong to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

Researchers looked at national data from Finland on 635,583 births occurring between 1996 and 2006, and found that 31 out of every 10,000 women who took Paxil during pregnancy gave birth to children with right ventricular outflow tract defects that affect blood flow from the right chambers of the heart to the rest of the body, more than four times the frequency of births among women who did not take Paxil. For those who took Prozac, 105 babies born out of every 10,000 had isolated ventrical septal defects; a hole between the left and right sides of the heart, which was more than double the rate of babies born to women who did not take the drug.

The researchers also found that women who took any SSRI antidepressant during pregnancy were more than twice as likely to give birth to a child with a neural tube defect; 22 out of every 10,000 newborns, as compared to 9 out of every 10,000 newborns born to women who did not take any SSRI during pregnancy.

SSRIs are a relatively new class of antidepressants, which help reduce symptoms of depression by preventing certain nerve cells in the brain from re-absorbing the chemical serotonin. These drugs are commonly used by millions of Americans with depression.

Although the drugs have been found to cause fewer side effects than older anti-depressants, research has shown that users of the drugs could also face an increased risk of suicides, and use during pregnancy has been linked to a risk of birth defects, especially among users of Paxil.

Prozac (fluoxetine) is marketed by Eli Lilly and is approved for the treatment of depression, obsessive-compulsive disorder (OCD) and other psychiatric problems. In 2007 there were more than 22 million Prozac prescriptions in the United States.

Paxil (paroxetine) is a selective serotonin reuptake inhibitor prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008.

In December 2005, the FDA issued an alert about the risk of birth defects from Paxil after studies showed the drug could increase the risk of the heart defects when taken during the first three months of pregnancy. At that time, the agency also required GlaxoSmithKline to update the warning label to include information about the risk of birth defects from Paxil side effects.

The company reportedly agreed to settle hundreds of Paxil heart birth defect lawsuits last year. The Paxil lawsuits were filed by parents who say that the use of the antidepressant during pregnancy caused persistent pulmonary hypertension in newborns (PPHN) and other birth defects. The lawsuits claimed that the company failed to warn consumers and doctors that use of Paxil during pregnancy could lead to congenital heart defects in newborns. The lawsuits also claimed that the company purposefully hid test results that would have revealed the side effects of Paxil and misled doctors.

http://www.aboutlawsuits.com/paxil-prozac-birth-defect-study-19139/

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Note from CCHR: Also see attorney Karen Barth Menzies interview on Paxil withdrawal effects and documents withheld from the public http://www.youtube.com/cchrint#p/c/B9EA75455D155D89/3/Mpex0n0DXuc

Bloomberg News

by Jeff Feeley, November 9, 2010

GlaxoSmithKline Plc,  the U.K.’s largest drugmaker, failed to properly warn consumers that its antidepressant drug Paxil could cause birth defects, a lawyer for the family of an injured teenager told jurors.

Glaxo officials had research from the 1980s showing Paxil caused deaths among the offspring of animal test subjects and didn’t provide clear warnings about those deaths, Kimberly Baden, a lawyer for Anna Blyth and her family, told a Philadelphia jury. Baden said the drug caused a narrowing of the aorta leading from the heart of Anna, now 14 years old.

“We believe the evidence will show Paxil caused Anna’s birth defects,” Baden said in opening statements in the trial. “We believe the warnings and instructions put out in 1995 weren’t appropriate and reasonable.”

The Blyth family’s case is the first over Paxil’s birth- defect risks to go to trial since the company agreed in July to pay more than $1 billion to settle 800 cases alleging the company failed to adequately warn consumers and their doctors about the drug’s hazards. The Blyth case wasn’t part of the settlement.

In the first Philadelphia trial, a jury ordered Glaxo in October 2009 to pay $2.5 million to the family of a 3-year-old boy born with heart defects his mother blamed on the drug.

$11.7 Billion in Sales

Glaxo officials contend Paxil played no role in Anna’s heart defects. They were most likely caused by genetics or the fact that her mother became pregnant late in life, Chilton Varner, a lawyer for the drugmaker, told jurors in her opening statement.

The deaths of Paxil animal test subjects had nothing “to do with Anna Blyth’s heart defects,” Varner said.

Approved in 1992 for U.S. use, Paxil generated about $793 million in sales in 2009, or about 1.8 percent of Glaxo’s total revenue. The company had $11.7 billion in U.S. Paxil sales over nine years starting in 1997, according to documents made public last year in a Pennsylvania trial over birth-defect claims.

Chief Executive Officer Andrew Witty has moved to replace revenue lost to generic versions of drugs such as Paxil. The drugmaker said in May it plans to double revenue from India and China by 2015 as it cuts prices to match competitors in emerging markets.

The company has paid out more than $2 billion to resolve a wave of litigation over Paxil, including claims the anti- depressant caused suicides in some users and withdrawal symptoms. In July, Glaxo set aside $2.4 billion to resolve litigation over Paxil and its Avandia diabetes drug.

Second Wave

After announcing its settlement of Paxil suits this summer, the company faced a second wave of suits over the drugs, said Carl Tobias, a University of Richmond law professor who teaches classes about mass-tort cases. That’s not unusual once a big- dollar settlement is on the table, he said.

“You’ll have plaintiffs lawyers who hope to get in on a settlement by going out and finding some new cases,” Tobias said. “Glaxo probably feels it had to litigate this case to send a signal that it’s not going to settle every one of these birth-defect cases, especially if they are weak.”

Sarah Alspach, a Glaxo spokeswoman, didn’t immediately return a call for comment on how many Paxil birth-defect cases remain outstanding.

In Anna’s case, the Summerville, South Carolina, resident had to undergo two rounds of open-heart surgery within nine months of her birth, Baden told jurors.

Her mother, Marsha Blyth, had taken Paxil for a short time during her pregnancy to deal with depression, Baden noted.

Glaxo’s Paxil warning label didn’t make it clear that offspring from animals on which the drug had been tested died, she said.

Read the rest of the article here: http://www.bloomberg.com/news/2010-11-09/glaxo-failed-to-warn-about-paxil-risks-lawyer-says-at-philadelphia-trial.html

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Despite evidence suggesting that Paxil could cause birth defects, Glaxo deliberately chose not to conduct studies that would have uncovered the true dangers of the drug.

The law firm of Hissey Kientz, LLP is pleased to announce the launch of its new website, Paxil Birth Defects Lawyers (http://www.paxilbirthdefectslawyers.com/). The site will serve as an information resource for the parents and families of children born with birth defects linked to their mothers’ use of Paxil during pregnancy. Multiple studies have found that the children of mothers who take Paxil while pregnant are at an increased risk of severe birth defects.

September 27, 2010

The law firm of Hissey Kientz, LLP is pleased to announce the launch of its new website, Paxil Birth Defects Lawyers (http://www.paxilbirthdefectslawyers.com/). The site will serve as an information resource for the parents and families of children born with birth defects linked to their mothers’ use of Paxil during pregnancy.

Paxil is part of a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). After it first went on the market in December 1992, Paxil has gone on to become one of the most widely prescribed drugs in the United States, with annual sales of $3.2 billion by 2002.

Multiple studies have found that the children of mothers who take Paxil while pregnant are at an increased risk of severe birth defects. In December 2005, the Food and Drug Administration called for stronger birth defects warnings on the drug’s labeling after two studies found that Paxil doubles the risk of birth defects when taken by women during the first trimester of pregnancy. Most of these birth defects involved cases of atrial and ventricular septal defects (holes in the walls of the chambers of the heart).

Paxil has also been linked to an increased risk of birth defects when taken later in pregnancy. A 2006 study published in the New England Journal of Medicine found that women who take Paxil or similar antidepressants after the 20th week of pregnancy are six times more likely to give birth to a child with persistent pulmonary hypertension of the newborn (PPHN), a condition which causes breathing and circulation problems that may lead to hospitalization or death.

Taking Paxil during pregnancy may also be linked to a number of other serious heart defects in newborns, including cardiomyopathy, tricuspid stenosis, cleft mitral valves, hypoplastic left heart syndrome (HLHS), hypoplastic right heart syndrome (HRHS), bicuspid aortic valves or patent ductus arteriosus (PDA).

Documents uncovered in the ongoing litigation against GSK [Paxil] products liability litigation (MDL-1574)] have revealed that GlaxoSmithKline, the drug’s manufacturer, was aware of the potential link between the antidepressant and birth defects as early as 1980, but failed to recall the drug or properly warn about its dangers until these risks were made public by researchers.

“Despite evidence suggesting that Paxil could cause birth defects, GlaxoSmithKline deliberately chose not to conduct studies that would have uncovered the true dangers of the drug,” says David Friend of Hissey Kientz, LLP. “It is impossible to say how many lives were drastically altered because of the company’s failure to heed the advice of experts and investigate the link between Paxil and birth defects.”

Read the rest of the article here: http://www.prweb.com/releases/2010/09/prweb4565144.htm

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Lawyers and Settlements
March 19, 2010

GlaxoSmithKline (GSK), the pharmaceutical giant responsible for medications like Advair, Geritol and Zantac, has seen an increased number of lawsuits related to SSRI birth defects stemming from its popular antidepressant, Paxil.

Paxil, a selective serotonin reuptake inhibitor (SSRI), has resulted in three separate kinds of lawsuits since its introduction to the market in 1992: cases citing the medication’s addictive nature, those citing the suicidal tendencies it can provoke and those that cite the frequency of birth defects in expectant mothers taking the medication.

SSRI medications have been linked to serious lung and heart defects in newborns, including persistent pulmonary hypertension, a disorder of the respiratory system that severely restricts the arteries causing the blood pressure in the pulmonary artery of the heart to rise to dangerous levels.

Read entire article:  http://www.lawyersandsettlements.com/articles/13802/ssri-birth-defects-side-effects-pphn-2.html

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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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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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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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