Posts Tagged ‘birth defects’

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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New study confirms the obvious: Babies of women taking antidepressants while pregnant have more health problems

Wednesday, November 4th, 2009

Amy Norton
ABC News
November 3, 2009

NEW YORK (Reuters Health) – Babies whose mothers used antidepressants during pregnancy visit the doctor more often and have higher risks of certain health problems than other children their age, a new study suggests.

The study looked at the medical records of nearly 39,000 Norwegian children through the first year of life. It found that rates of congenital heart defects and physical therapy — a potential sign of movement-related problems — were elevated among babies whose mothers used antidepressants throughout pregnancy.

These children also tended to have more doctor visits and higher rates of certain other health problems, like respiratory and digestive symptoms. However, those rates were also elevated among children whose mothers had stopped using antidepressants before pregnancy.

Read entire article: http://abcnews.go.com/Health/wireStory?id=8986268

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GlaxoSmithKline ordered to pay $2.5 for Paxil-caused birth defects in first of 600 such cases

Tuesday, October 13th, 2009

Jef Feeley and Sophia Pearson
Bloomberg.com
October 13, 2009

GlaxoSmithKline Plc must pay $2.5 million over claims that its Paxil antidepressant caused birth defects, a Pennsylvania jury concluded in the first of 600 such cases to come to trial.

Jurors in state court in Philadelphia deliberated about seven hours over two days before finding Glaxo failed to properly warn doctors and pregnant users of Paxil’s risk. The panel awarded $2.5 million in compensatory damages to the family of Lyam Kilker. The 3-year-old was born with heart defects his mother blamed on the drug.

“The first win is always huge, especially when you get a jury saying the drug caused the injury,” Sean Tracey, the family’s lawyer, said in an interview after the verdict.

It’s the first time a jury has considered claims that Glaxo, the U.K.’s largest drugmaker, knew Paxil caused birth defects and hid the risk to increase profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, or 2.1 percent of Glaxo’s total revenue.

Read entire article: http://www.bloomberg.com/apps/news?pid=20601103&sid=a3MSErCD3DfY

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