Pharmalot
By Ed Silverman
July 21, 2010

In an effort to get its arms around massive litigation, GlaxoSmithKline has agreed to settle yet another wad of product-liability lawsuits involving one of its popular meds. The latest deal involves an agreement to pay more than $1 billion to settle some 800 cases alleging its Paxil antidepressant caused birth defects in children borne to women who took the drug, Bloomberg News writes.

The move comes after a Pennsylvania state court jury last October awarded a woman $2.5 million in damages for failing to properly warn docs and pregnant women about the risks of the antidepressant. This case, which was filed by the family of a three-year-old boy who was born with heart defects his mother blamed on the drug. It was the first of 600 such lawsuits and was seen as a test of Glaxo’s vulnerability (background).

Last week, Glaxo disclosed plans to take a $2.4 billion charge in its second quarter to settle product-liability lawsuits over its Avandia diabetes pill, litigation involving the Paxil antidepressant and a US government investigation into its manufacturing site at Cidra, Puerto Rico.

The Paxil deal, which would provide an average payout of more than $1.2 million to families of the affected children, leaves more than 100 similar cases pending. The birth-defect settlements bring to more than $2 billion the amount Glaxo has agreed to pay to resolve a variety of Paxil-related suits, including claims the pill caused suicides or attempted suicides and addiction problems, Bloomberg writes.

Read the entire article here:  http://www.pharmalot.com/2010/07/glaxo-to-pay-1b-to-settle-paxil-birth-defect-cases/

See all international studies/warnings on Paxil: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

See what doctors, pharmacists, health care providers and others have reported to the US FDA on Paxil side effects (such as birth defects): http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

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Medscape
By Deborah Brauser
July 2, 2010

Psychotropic medications are associated with adverse drug reactions (ADRs), many of which are serious, in children younger than 17 years, according to a new database study from Danish researchers.

Results also showed that all but one of the psychotropic-related ADRs for children between the ages of birth and 2 years were serious, including birth defects such as neonatal withdrawal syndrome, ventricular septal defects, and premature labor.

These findings were “probably due to the mothers’ intake of psychotropic medicine, primarily antidepressants and antipsychotics, during pregnancy,” write the study authors.

For the overall patient population, the largest share of reported ADRs came from psychostimulants (42%), followed by antidepressants (31%) and antipsychotics (24.5%).

“The high number of serious ADRs reported for psychotropic medicines in the pediatric population should be a concern for health care professionals and physicians,” the study authors write.

In addition, “clinicians must be aware of the risks for the unborn child if they treat pregnant women with [these drugs],” coinvestigator Ebba Hansen, MSc, professor of social pharmacy and director for the FKL-Research Center for Quality in Medicine Use at the University of Copenhagen, Denmark, told Medscape Medical News.

She noted that many of the general practitioners interviewed for this study “thought that SSRI [selective serotonin reuptake inhibitor] antidepressants are harmless. Therefore, we recommend that treatment of pregnant women with psychotropic drugs should be an issue for specialists only.”

The study is published online in BMC Research Notes.

ADR Evidence Lacking

Although regulatory authorities have issued warnings about risks associated with the use of psychotropics in pediatric patients, “little evidence has been reported about the ADRs of these medicines in practice,” write the study authors.

“Overall, we have very little information about [ADRs] in children, and especially in infants, as vulnerable groups are excluded from the clinical trials that document a medication’s efficacy and safety before licensing and marketing,” said Professor Hansen.

For this study, her team evaluated 4500 ADRs in children listed in the national Danish ADR database between 1998 and 2007.

“Spontaneous ADR reporting [is] an important contributor to knowledge about safety of medicines,” the study authors write. They note that spontaneous reports are “the main source for information about new and previous unknown ADRs.”

Serious ADRs Found

Results showed that 429 of the ADRs reported during the study period were for psychotropic medications. Of these, 241 (56%) were deemed serious.

A total of 50% of the psychotropic ADRs reported were for adolescents between the ages of 11 and 17 years (n = 214), of which 45% were serious. Almost 19% were for children between the ages of birth and 2 years (n = 80).

In addition, 39% of the overall psychotropic-related ADRs were from the “nervous and psychiatric disorders” categories. When looking at sex, 59% of the total ADRs reported were for boys.

A total of 79 of the 80 ADRs associated with psychotropics in the children younger than 2 years were serious, and 2 of these were fatal (one was associated with citalopram due to chorioamnionitis and the other with fluoxetine due to persistent fetal circulation).

Finally, 40% of all psychotropic ADRs were associated with the psychostimulants methylphenidate and atomoxetine, whereas 59% of the ADRs reported for antipsychotics were associated with ziprasidone, olanzapine, and risperidone. A total of 61% of the total ADRs reported for antidepressants were with sertraline and citalopram.

Read entire article:  http://www.medscape.com/viewarticle/724547
(Free registration required for Medscape)

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HealthJockey.com
June 28, 2010

Some psychotropic drugs may be recommended to treat depression as they are believed to affect the mind, emotions, and behavior of an individual. But these medications appear to elevate the risk for various birth defects. As a recent study initiated by the University of Copenhagen suggests, the consumption of psychotropic medication ought to be avoided during pregnancy.

Investigators observed the link of psychotropic medications with birth defects. They analyzed the data between 1998 and 2007 regarding Danish children under the age of 17. The study claims that the data highlighted 429 adverse drug reactions in these children. After thorough examinations the authors concluded that more than half of these cases indicated extreme birth defects including birth deformities and severe withdrawal syndromes.

Associate Professor Lisa Aagaard affirmed, “A range of serious side effects such as birth deformities, low birth weight, premature birth, and development of neonatal withdrawal syndrome were reported in children under two years of age, most likely because of the mother’s intake of psychotropic medication during pregnancy.”

In addition, the investigators inspected 4,500 pediatric adverse drug reaction reports and revealed a clear link between psychotropic medications and birth defects. It was ascertained that psychostimulants like Ritalin known to treat attention deficit disorder (ADD) was accountable in 42 percent of unfavorable reactions. And while antidepressants such as Prozac probably caused 31 percent reactions, 21 percent were contributed by antipsychotics similar to Haldol.

Read entire article: http://www.healthjockey.com/2010/06/28/birth-defects-appear-due-to-intake-of-psychotropic-medications-during-pregnancy/

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Fair Warning
By Lea Yu
June 25, 2010

Pharmaceutical giant GlaxoSmithKline has entered into confidential settlements with nearly 200 families who claimed that its antidepressant Paxil caused congenital birth defects.

Most of the claims alleged that babies born to mothers taking Paxil suffered heart defects. Last October, a suit filed on behalf of Lyam Kilker said he was born with three cardiac defects, including a hole between two chambers of his heart that disrupted the aorta.

Kilker’s case is the only one to have gone to trial, and a Philadelphia jury awarded Kilker’s family $2.5 million in compensatory damages. Plaintiffs argued that animal testing revealed potential problems with Paxil, but the company did not follow up with additional tests. A company memo introduced as evidence during the trial also revealed that Glaxo considered covering up any negative test results. “If neg, results can bury,” the 1997 memo said.

In 2005, the Food and Drug Administration warned doctors about a 35,000-person study that found that pregnant women on Paxil were twice as likely to have a child with defects than women taking other antidepressants.

Read entire article:  http://www.fairwarning.org/2010/06/glaxosmithkline-settles-200-birth-defects-cases-linked-to-antidepressant/

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Lawyers & Settlements
By LucyC
June 2, 2010

A new study out yesterday—June 1, 2010—has revealed a higher rate of miscarriages in women who were taking antidepressants during pregnancy. How much higher? Sixty-eight percent—yes —that’s 68%—higher. Frankly, that is nothing short of shocking.

Published in the Canadian Medical Association Journal, the study was done in Canada through the University of Montreal. FYI—This was no small study either—the investigators used data from 5,124 women who are part of a large, population-based study of pregnant women who had clinically verified miscarriages, and a large sample of women from the same registry who did not have a miscarriage. Among the women who miscarried, 284 or 5.5 percent, had taken antidepressants during their pregnancy.

In fact the findings are so robust that the physicians who did the study are suggesting that this is a class effect—in other words the effect could be attributed to all selective serotonin reuptake inhibitors—or SSRIs. Here’s what’s being reported in the press:

“These results, which suggest an overall class effect of selective serotonin reuptake inhibitors, are highly robust given the large number of users studied,” the study’s senior author, Dr. Anick Berard, said in a statement. (UPI.com)

The antidepressants that showed a particular association with miscarriage in the study were paroxetine (trade names: Seroxat and Paxil) and venlafaxine (trade names: Effexor, Efexor, Alventa, Argofan, Trevilor). The investigators also found that the risk of miscarriage doubled with a combination of different antidepressants.

Just for the record, the antidepressants “investigated” in the University of Montreal study are serotonin reuptake inhibitors (citalopram, fluoxetine, fluvoxa-mine, paroxetine and sertraline); tricyclic antidepressants (ami-triptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, trimipramine), serotonin– norepinephrine reuptake inhibitors (venlafaxine) and “other antidepressants” (serotonin modulators, monoamine oxidase inhibitors, tetracyclic piperazino-azepines, and dopamine and norepinephrine reuptake inhibitors).

This study is just the latest to show an association between, well, for lack of a better term let’s say “serious adverse events” and SSRIs and SNRIs in particular.

Read entire article:  http://www.lawyersandsettlements.com/blog/mom-alert-would-you-want-a-68-higher-risk-of-miscarriage-03819.html

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Los Angeles Times
By Thomas H. Maugh II
May 31, 2010

Taking antidepressants during pregnancy increases the risk of spontaneous abortions by about two-thirds, Canadian researchers reported Monday. The increased risk was greatest with the family of drugs known as selective serotonin reuptake inhibitors (SSRIs), especially paroxetine and venlafaxine, and when more than one family of drugs were used.

Depression in women is most common during the child-bearing years, and estimates suggest that as many as 15% of pregnant women suffer from it. Because of fears about the effects of drugs, particularly psychiatric drugs, during pregnancy, only about 3.7% of women use them during the first trimester. Most studies looking at the use of antidepressants during pregnancy have focused on their effects on the fetus. Small studies of their effects on abortion have produced inconsistent results. Expecting mothers cannot routinely stop using the drugs, however, because that also presents risks to both the mother and the fetus.

Producing a controlled clinical trial examining the effects of the drugs is virtually impossible because few women would be willing to participate, experts said. The only way to get at the data is to examine it retrospectively.

In the new study, Dr. Anick Berard, director of the University of Montreal’s Research Unit on Medications and Pregnancy at University Hospital Center Sainte-Justine used information from the Quebec Pregnancy Registry to identify 5,124 women who had a spontaneous abortions between 1998 and 2003 — before warnings about the risks of the drugs became more common — and compared them with about 10 times that many carefully matched women who did not have abortions. A separate database provided information about prescriptions the women had filled.

Read entire article:  http://latimesblogs.latimes.com/booster_shots/2010/05/antidepressants-during-pregnancy-increase-risk-of-sponaneous-abortion-study-finds.html

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The Daily Mail
By Jo MacFarlane
May 16, 2010

Women who use antidepressants while pregnant are being warned by health chiefs about the risks to their unborn child.

The Government’s medicines watchdog advised doctors there is an increased risk that babies will be born with a rare lung condition if expectant mothers take drugs such as Prozac and Seroxat.

The Medicines and Healthcare products Regulatory Agency (MHRA) is recommending they are monitored more carefully because of the risk of developing persistent pulmonary hypertension after birth.

The condition normally affects up to two in 1,000 births – but the latest research suggests the risk is more than doubled in women taking antidepressants, affecting five in 1,000 births. The life-threatening condition means infants do not adapt to breathing outside of the womb.

The risk is greater if the medicines known as SSRIs – a new generation of depression wonder drugs – are taken later in the pregnancy.

The warning comes five years after studies first showed there may be a link between the drugs and birth defects. The MHRA advised doctors not to prescribe the drugs to pregnant women unless necessary.

However, it was revealed last year that GPs were still prescribing them to women considering becoming pregnant.

Read entire article:  http://www.dailymail.co.uk/health/article-1278675/Pregnant-women-warned-antidepressants-danger-unborn-child.html?ito=feeds-newsxml

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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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Bounty
March 12, 2010

Women expecting a baby have been warned over taking Prozac while they are pregnant, after a new study found it could be harmful to an unborn child.

According to a study from the Medicines and Healthcare Products Regulatory Agency there is a “small risk” of babies developing heart problems should their mother take the drug early on in their pregnancy.

The researchers behind the study said that pregnant mothers who use Prozac could be twice as likely to have children with a congenital heart problem, such as a murmur, or a hole in the heart.

Read entire article:  http://www.bounty.com/node/2191

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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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