Posts Tagged ‘birth defects’

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Taking Antidepressants During Pregnancy Doubles Heart Defect Risk of Newborns

Friday, February 19th, 2010

Natural News
By David Gutierrez
February 19, 2010

Women who take certain antidepressant drugs while pregnant may double their child’s risk of being born with a certain variety of heart defect, according to a study conducted by researchers from Aarhaus University in Denmark and published in the medical journal BMJ.

“Anyone who is pregnant or considering becoming pregnant and has any concerns about the treatment for depression should speak to their doctor,” said Cathy Ross of the British Heart Foundation.

Researchers compared the risk of birth defects in 1,370 children born to women who took at least one selective serotonin reuptake inhibitor (SSRI) while pregnant with the risk in 400,000 other children whose mothers had not taken any SSRIs while pregnant. They found that the drugs fluoxetine (marketed as Prozac), sertraline (marketed as Zoloft) and citalopram (marketed as Celexa) all significantly increased the risk that a child would be born with a defect in the septum, which separates the right and left halves of the heart.

Septum defects include a variety of conditions from minor blood vessel problems to outright holes in the heart. The researchers found that one extra septum defect would develop for every 246 pregnant women taking an SSRI during the time period from 28 days before through 112 days after conception.

Taking more than one SSRI drastically increased the risk of septum defects. While the risk of the defects was 0.5 percent in mothers not taking the drugs and 0.9 percent in those taking one drug (an 80 percent increase), it was 2.1 percent in mothers taking two or more (a more than 300 percent increase).

Read entire article:  http://www.naturalnews.com/028202_antidepressants_heart_defects.html

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Paxil Birth Defect Litigation – 600 Cases Pending

Wednesday, February 17th, 2010

Scoop Independent News
By Evelyn Pringle
February 18, 2010

GlaxoSmithKline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in 1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania.

Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service.

First Trial A Bust for Glaxo

The first trial, in the case of Kilker v Glaxo, ended with a jury in Philadelphia finding that Glaxo “negligently failed to warn” the doctor treating Lyam Kilker’s mother about Paxil’s risks and the drug was a “factual cause” of Lyam’s heart defects. The jury awarded the family $2.5 million in compensatory damages.

After the trial, juror Joe Mellon told Bloomberg that Glaxo did not conduct adequate studies on Paxil. “There were a couple of what I thought were safety signals and what the plaintiffs presented as safety signals that they should have maybe looked into further,” he said.

On October 14, 2009, the American Lawyer reported that the plaintiff’s lead attorney, Sean Tracey, had quizzed the jurors about what swayed their decision. “They said the fact that GSK never adequately studied their own drug was a big deal,” Tracey said. “The animal testing they did showed that they had a potential problem, and they didn’t follow up with adequate studies on animals or humans.”

Read entire article:  http://www.scoop.co.nz/stories/HL1002/S00128.htm

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In addition to causing birth defects & preterm labor—new study says antidepressants cause breastfeeding problems

Thursday, January 28th, 2010

AttorneyAtLaw.com
January 27, 2010

Taking Prozac, Paxil, or other antidepressants from the class of drugs called selective serotonin reuptake inhibitors (SSRIs) can cause delays in lactation in new mothers and difficulty in breast-feeding newborns, a new study says.

Researchers from the University of Cincinnati found SSRIs can result in delayed secretory activation after giving birth. SSRIs regulate the hormone serotonin in the body to stave off depression, but the hormone also is crucial to the breasts’ ability to deliver milk when it is needed, the study’s authors said.

A delay in breast milk production caused by taking SSRIs can “impact serotonin regulation in the breast, placing new mothers at greater risk of a delay in the establishment of a full milk supply,” the study found.

The study’s findings are troubling because millions of people take Prozac, Paxil, and other brands of SSRIs to treat a variety of depression-related disorders. Paxil and other SSRI drugs have been linked before to other serious health complications, including heart-related birth defects and pre-term labor.

Read entire article:  http://www.attorneyatlaw.com/2010/01/prozac-and-paxil-can-cause-breast-feeding-problems-new-study-says/

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Daily Mail – “Internal bleeding. Strokes. Birth defects. The long term effects of antidepressants are terrifying”

Tuesday, January 12th, 2010

Jane Feinmann
The Daily Mail
January 12, 2010

Just a few years ago, Yasmin Miller would have been horrified by the suggestion she might take antidepressants for the rest of her life. But today, the 37-year-old can barely imagine a future without this daily chemical boost.

Yasmin’s ‘perfect’ life as a corporate tax adviser was shattered when, in 2003, she developed severe depression. Although incapacitated by the illness, she needed convincing that a pill could make a difference.

‘I was gobsmacked when my GP suggested antidepressants, because I thought they were addictive,’ she recalls. ‘But now I’ve changed my mind: depression is just like epilepsy or diabetes or any other illness where you need to take a daily pill for life in order to stay healthy.’

Just 20 years after the launch of the ’sunshine drug’ Prozac, Yasmin is one of hundreds of thousands of young women who can’t imagine life without antidepressants.

But some experts are warning of disturbing parallels with the ‘mother’s little helper’ scandal of the Seventies and Eighties, when thousands of women became addicted to widely prescribed tranquillisers, including Valium.

Read entire article: http://www.dailymail.co.uk/health/article-1242502/Hooked-happy-pills-Internal-bleeding-Strokes-Birth-defects-The-long-term-effects-antidepressants-terrifying.html

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Paxil birth defect settlement tops list of “most impactful” lawsuit settlements for 2009

Tuesday, December 15th, 2009

Kristine B.
LawyersandSettlements.com
December 15, 2009

We’re in the countdown to year-end and looking over some of the more impactful settlements LawyersAndSettlements.com has covered over the past year. When we’re talking impactful, everyone around here has an opinion—so we had to throw in some criteria. To get the nod for impact, a settlement had to be one of two things: 1. High dollar value; or 2. Precedent-setting—or at least have the potential to influence similar cases to follow. (Sounds simple, but you try getting Stephen, John, Jaime, Michelle and Ben to settle in on just 7 settlements with just those criteria…) So here we go…7 game-changing settlements for ‘09…

1) Family takes on GlaxoSmithKline

Michelle David filed a lawsuit against GlaxoSmithKline, alleging the company’s antidepressant, Paxil was responsible for her son’s birth defects. David said she had taken Paxil while pregnant and was not aware of the potential side effects. GlaxoSmithKline said that birth defects occur in between three and five percent of all live births, regardless of Paxil use.

Read entire article: http://www.lawyersandsettlements.com/blog/7-game-changing-settlements-of-2009-02165.html

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That British Drug Maker Glaxo’s $1 Billion Paxil Settlements Were Disclosed by Press – Not Drug Maker – Is Cause for Concern

Tuesday, December 15th, 2009

Jim Edwards
BNET
December 15, 2009

British drug company GlaxoSmithKline (GSK) has paid $1 billion to settle lawsuits related to Paxil. The fact that it was disclosed by Bloomberg and not the company itself illustrates how lousy financial disclosure rules are in Europe and why drug companies based there cannot be trusted to tell the truth about what is going on with their litigation liabilities and, by extension, the safety of their drugs.

Bloomberg got the $1 billion number by piecing together litigation records, analysts’ reports and GSK’s own partial statements on the issue. But compare the Paxil situation with those faced by Eli Lilly (LLY) and AstraZeneca (AZN). Both companies have been engaged in litigation that has cost them billions (over the antipsychotics Zyprexa and Seroquel, respectively). And both companies have disclosed the full legal bill attached to those suits. (It’s more than $3.3 billion for Lilly and $1.1 billion for AZ.

Those numbers were disclosed in both companies’ earnings reports. Interestingly, Lilly disclosed them because it was required to report anything “material” by the SEC — it’s an American company and that’s the law. Fines and prosecutions await American firms that fail to report bad news.

Read entire article: http://industry.bnet.com/pharma/10005807/gsks-1b-paxil-problem-highlights-murky-disclosures-from-euro-drug-companies/

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Glaxo Said to Have Paid $1 Billion in Paxil Suits Including About $390 Million for Suicides/Attempted Suicides Linked to Drug

Monday, December 14th, 2009

Jef Feeley and Margaret Cronin Fisk
Bloomberg.com
December 14, 2009

GlaxoSmithKline Plc has paid almost $1 billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993, including about $390 million for suicides or attempted suicides said to be linked to the drug, according to court records and people familiar with the cases.

As part of the total, Glaxo, the U.K.’s largest drugmaker, so far has paid $200 million to settle Paxil addiction and birth-defect cases and $400 million to end antitrust, fraud and design claims, according to the people and court records.

The $1 billion “would be worse than many people are expecting,” said Navid Malik, an analyst at Matrix Corporate Capital in London. “I don’t think this is within the boundaries of current assumptions for analysts.”

The London-based company hasn’t disclosed the settlement total in company filings. It has made public some accords. Glaxo’s provision for legal and other non-tax disputes as of the end of 2008 was 1.9 billion pounds ($3.09 billion), according to its latest annual report. This included all legal matters, not just Paxil. The company said 112 million pounds of this sum would be “reimbursed by third-party issuers.”

Read entire article: http://www.bloomberg.com/apps/news?pid=20601103&sid=aWNKB4YPWjIY

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And yet another FDA warning – Depakote – used to treat people diagnosed “Bipolar” found to cause severe birth defects

Thursday, December 3rd, 2009

FDA MedWatch Safety Information
Dec. 3, 2009

Audience: Neurological and Obstetrical healthcare professionals

The FDA notified health care professionals and patients about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. Healthcare practitioners should inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.

Read entire article:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm

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Pregnant women should stop medications which cause birth defects: “Psychiatric drugs can & should be avoided”

Monday, November 30th, 2009

The Daily Inquirer
November 29, 2009

Canadian researchers are saying that women who are planning to become pregnant should take an inventory of the medications they take.

The researchers have found that many pregnant women still take medications which can cause birth defects.

Dr. Anick Berard, at the University of Montreal in Quebec, said drugs that control epilepsy are essential during pregnancy, albeit known to have fetal risk.

However, medications such as those which treat severe acne, anxiety and psychiatric drugs, antibiotics, and many drugs prescribed for heart disease and medical conditions “can and should be avoided,” according to Berard.

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The New American: The Healthcare Bill’s Sops to the Mental-health Industry

Friday, November 6th, 2009

Beverly K. Eakman
The New American
November 5, 2009

Most people (including Members of Congress and the press) won’t read the nearly 2,000-page healthcare bill (“Affordable Health Care for America Act”: H.R. 3962). Consequently, like most Americans, they are oblivious to the elephant in the living room that’s about to transform the nation. While legislators shadow-box over public-versus-private options, trillion-dollar debts, and socialized medicine, tucked away in the bill under warm and fuzzy labels are numerous sops to the mental-health industry.

If enacted, these will serve to prop up an already misrepresented collection of disorders and channel ever-more-billions into the psycho-pharmaceutical industry that could be better directed toward research for cancer, heart disease, multiple sclerosis, and a host of other known, physical ailments that cost families a fortune and send their victims to gruesome, painful deaths.

Worse, however, is what this bill will do to America as a constitutional republic — and indeed what is left of the entire free world, since no doubt it will follow the United States’ lead. With legal legitimacy for unprovable mental disorders will come, inevitably, an excuse to marginalize individuals on the basis of conscience, outspokenness, and politics. Thus far, the United States has been among the few countries to dodge that particular bullet — even though we have been moving ever-closer for 40 years to that outcome via draconian measures aimed at instituting political correctness. But this bill will send the issue over the edge and discourage anyone from honest exchanges of ideas.

Most Members of Congress, unfortunately, rely on youngish aides to provide synopses of a bill’s provisions. Elected politicians, most of whom know little about medicine anyway, can hardly be expected to read and analyze a document that exceeds the size of War and Peace in the space of a few days, complete with technical and legal jargon. Their aides, unfortunately, are mostly products of a failed and politicized education system that has spent some four decades skipping over the particulars of our Constitution and the related debates of its Framers. So, to expect such individuals to catch mistakes that might compromise the health of the republic, not to mention the physical health of the populace, is wishful thinking.

Read entire article: http://www.thenewamerican.com/index.php/usnews/health-care/2246-the-healthcare-bills-sops-to-the-mental-health-industry

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