Paxil Lawsuit & News Blog

SSRIs (Antidepressants) and Birth Defects: How Concerned Should Woman Be? What are the risks associated with Paxil?

Mon, 9 Jul 2007 15:04:32 -0400

New research reveals that SSRIs are not major causes for the malformation of a developing fetus. SSRIs (Selective Serotonin Reuptake Inhibitors) are often prescribed for depression, a relatively common condition among women.

Previous reports had suggested that use of SSRIs (particularly Paxil and Paxil CR) during early pregnancy is associated with an increased risk for heart defects. Reports from two large ongoing case control studies provide new data on the risks associated with prenatal exposure to SSRIs.

Investigators from the Centers for Disease Control (CDC) and the University of British Columbia studied 9,622 case infants with major birth defects (identified through birth defect surveillance systems in eight states) and 4,092 controls born from 1997 through 2002. Overall, the authors observed no significant associations between maternal SSRI use during early pregnancy and congenital heart defects or most other categories of birth defects. Specifically, maternal SSRI use was associated with anencephaly (odds ratio, 2.4) craniosynostosis (odds ratio 2.5), and omphalocele (odds ratio 2.8).

The use of Paxil correlated with a higher pooled odds ratio for the birth defects of craniosynostosis (restricted skull growth), omphalocele (abdominal wall defect caused by fetal abnormality), and anencephaly (a major portion of the brain is reduced or absent) for these three major birth defects and with a significantly increased risk for right ventricular outflow tract obstruction defects.

In a second study, investigators funded by the makers of Paxil and by the National Institute of Health (NIH) studied 9,849 case infants and 5,860 controls born in the United States and Canada from 1993 through 2005. Overall, SSRI use was not associated with risk for heart defects, craniosynostosis, or omphalocele. However, Paxil use correlated with a significantly increased risk for right ventricular outflow tract obstruction defects.

The authors of both studies pointed out that the absolute risks associated with SSRI use during pregnancy were small in relation to the risk for birth defects in the general population.

These two new reports clarify that SSRIs are not major causes of birth defects. This information plus the knowledge of the risks associated with discontinuing an SSRI during pregnancy should help women make decisions relative to managing depression. For women taking SSRIs during early pregnancy, targeted second trimester ultrasound makes sense. Women who choose to discontinue their SSRIs during or just before pregnancy will likely benefit from psychiatric monitoring be required.

Source: Journal Watch Women's Health

FDA Announces Misleading Warnings about Paxil

Thu, 14 Jun 2007 12:09:51 -0400

On May 2, 2007, the FDA announced its most misleading warnings to date about selective serotonin reuptake inhibitor (SSRI) antidepressants like Paxil when it said the drug makers would revise the current black box warning of increased risk of suicides in children and adolescents to include adults. The caveat -- only young adults ages 18 to 24. Apparently at the quarter century mark of 25 the increased risk no longer exists.

An FDA advisory committee held a public hearing on December 13, 2006 to review drug company data that show SSRIs like Paxil to be associated with adult suicide. The commonly prescribed SSRIs in the United States include Prozac, by Eli Lilly; Paxil by GlaxoSmithKline; Zoloft by Pfizer; and Celexa and Lexapro by Forest Labs, along with various generic versions of the drugs.

Many of the world's leading experts on psychiatric drugs traveled to Washington to appear at the hearing, some of whom have spent years investigating the adverse events associated with SSRIs, to testify about the need to extend the back box warnings about suicide to all age groups.
Advocates and experts alike are outraged over the limited warning, which is widely viewed as another gift to the drug makers by the FDA.

Not only does the new warning label continue to minimize the adverse reactions of the antidepressants on the entire population but is now become a cheerleader for the psychiatric community. The FDA has made some seriously misleading statements that will lead patients and physicians into a false sense of security."

Critics say the nation's regulatory agencies under the Bush administration have evolved into a protection network for drug makers, in large part, because the industry has created a revolving door where top officials move directly from their government employment into high-paying positions with drug companies.

The latest evidence of this charge appeared in the media on May 4, 2007, with a press release by Prozac-maker Eli Lilly, announcing that Alex Azar II will be joining Lilly as senior vice president, who until February 3, 2007, was the Deputy Secretary of Health and Human Services and served as the chief operating officer of the largest civilian department in the federal government.

According to the Indianapolis Star, Azar takes over the Lilly post as seven states are suing the company, alleging that it promoted off label uses for Zyprexa, its top selling drug approved for schizophrenia and bipolar disorder.

Many other experts agree that safety decisions should not be based on drug maker studies. The research designs used by these studies are incredibly unfair and yet the FDA is allowing this system to continue.
Independent research investigations repeatedly find adverse events are much, much higher than the rates reported in the studies submitted to the FDA by the drug manufacturers.

The FDA's statement that scientific data does not show an increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicide is extremely misleading.

Critics also find this statement disturbing in light of other independent studies, including a study reported in the May 1, 2006, London Free Press, conducted at the Toronto's Institute for Clinical Evaluative Sciences, that identified suicides among older Ontarians, 66 and up, and found that for patients who were prescribed antidepressants in the six months before their deaths, the risk of suicide in the first month for those taking SSRIs like Paxil was nearly five times higher than for seniors taking older antidepressants called tricyclics such as Elavil.

Most patients with milder depression would get well if seen by a sympathetic physician or therapist and describes three side effects that have resulted from the SSRI controversy. Physicians seem to have lost confidence in their own ability to help patients without drugs.

The FDA just commissioned a series of three year studies to evaluate the adult suicide problem and by the time these studies are done and released, the bulk of the medications will be either off or going off patent.

Source: Evelyn Pringle - http://www.scoop.co.nz/stories/HL0705/S00440.htm

Paxil Caused Teen's Suicide

Tue, 12 Jun 2007 12:11:43 -0400

Source: http://www.thetimesonline.com/articles/2007/06/13/news/top_news/doc033e30e9c6967a82862572f80081b832.txt

Scott Randall Cunningham was a typical eighth-grader with all the concerns that physicians and parents might expect to see in a 14-year-old. He talked to his mom about girls, got caught smoking, had an active social life and yearned to work at Taco Bell, where his favorite food was served.

Yet when he told his counselor that the stresses of life were getting to him, he received a prescription for the antidepressant Paxil. Six weeks later, he died as a result of trying to commit suicide.

Four years after the death, GlaxoSmithKline, the manufacturer of Paxil, began printing a disclaimer with Paxil warning that the drug increased the risk of suicidal thinking and behavior in some adolescent users of the drug.

The family has joined dozens of other families across the nation suing GlaxoSmithKline. They contend the drug industry hid the dangers that antidepressants pose a problem for the adolescents who take them.

Filed last year in Pennsylvania, the Cunningham's case was transferred to U.S. District Court in Hammond earlier this month. The lawsuit alleges fraud and negligence and seeks undisclosed monetary damages for the family.

Expanding the Black Box - Depression, Antidepressants, and the Risk of Suicide by Richard A. Friedman, M.D., and Andrew C. Leon, Ph.D.

Thu, 7 Jun 2007 08:00:02 -0400

"On May 2, 2007, the Food and Drug Administration (FDA) ordered that all antidepressant medications carry an expanded black-box warning incorporating information about an increased risk of suicidal symptoms in young adults 18 to 24 years of age. Since October 2004, antidepressants have been required to have a black-box warning indicating that they are associated with an increased risk of suicidal thinking, feeling, and behavior in children and adolescents." (NEJM Volume 356:2343-2346 June 7, 2007 Number 23)

$64M Deal Approved in Paxil Settlement

Fri, 1 Jun 2007 06:38:08 -0400

"Parents who bought the antidepressant Paxil for their children can begin seeking reimbursements under a $64 million class-action deal settling claims that the drug's maker misled consumers about the medication's safety. Under the deal, announced in April and granted final approval last week by a judge in Madison County, Ill., parents with proof that they bought GlaxoSmithKline PLC's Paxil and Paxil CR, a controlled-release version of the drug, can recoup out-of-pocket expenses. Parents who no longer have pharmacy records or receipts can get up to $100 refunded by signing a claim form that carries penalties for lying. In settling the 2004 lawsuit, Britain-based GlaxoSmithKline denies claims it promoted the drug to children while withholding information about negative side effects, including increased suicidal behavior."

Jim Shur, Associated Press, Forbes 5/24/07
http://www.forbes.com/feeds/ap/2007/05/24/ap3755611.html

Paxil and Zoloft, with half-lives of one day, proved more difficult to get off than Prozac

Tue, 8 May 2007 08:36:23 -0400

This article is mostly about this writer’s attempt to get off of Effexor but does mention Paxil fleetingly once or twice.

In their studies, Rosenbaum and Fava found that Paxil and Zoloft, with half-lives of one day, proved more difficult to get off than Prozac, with a half-life of four to six days. Effexor, the drug I was on, has the shortest half-life of all: five or six hours.

http://www.nytimes.com/2007/05/06/magazine/06antidepressant-t.html?ref=magazine

FDA - MedWatch - Antidepressant Medications - FDA Proposes That Manufacturers Update Product Labeling To Include New Warnings About Suicidal Thinking and Behavior In Young Adults

Thu, 3 May 2007 06:12:48 -0400

Date: Wed, 2 May 2007 15:03:28 -0400
From: CDER MEDWATCH LISTSERV
Subject: FDA - MedWatch - Antidepressant Medications - FDA Proposes That Manufacturers Update Product Labeling To Include New Warnings About Suicidal Thinking and Behavior In Young Adults

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns.
Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes.

Quit Paxil: Real Life Experiences

Tue, 1 May 2007 10:07:43 -0400

In 1999 when the owner of this website decided to quit Paxil, he went through extreme withdrawal. When he tried to find out information about his symptoms there was none so he put up a website. Soon other Paxil people found him and started posting their experiences and then the lawyers came.

Since then his website has grown to include hundreds of people who were deeply troubled by their Paxil experiences and trying to quit Paxil experiences. This is what the drug companies don't want you to know. 4 to 10 percent of people who withdraw from Paxil will experience life threatening and very uncomfortable withdrawal symptoms such as intense fear of losing your sanity, extreme dizziness, insomnia, slurred speech, blurred vision, burst into tears, loss of concentration, hypersensitivity to sounds and smells, suicidal thoughts and actions, and more. Most Paxil users will feel like they have the flu for a few days of withdrawal.

souce: http://www.quitpaxil.org

Getting off Paxil is difficult and dangerous

Mon, 30 Apr 2007 10:06:59 -0400

Paxil dangerous? - http://www.rockymountainnews.com/drmn/health/article/0,2777,DRMN_23956_5487832,00.html

Breaking up is hard to do: For people who have taken Paxil and other SSRIs, getting off the drugs and moving on is not so easy. About 30 percent of people who try to wean themselves from Paxil, fail because of symptoms like dizziness and electric-like zaps shooting through their head. These people suffer from SSRI discontinuation syndrome.

Some doctors have stopped prescribing Paxil for depression. Some withdrawal symptoms include extreme insomnia, vivid dreams, confusion during waking hours, mood swings, panic attacks, unsteady gait, and feeling like an electrical current is going through your body. These Paxil withdrawal symptoms can last from two to six weeks after stopping Paxil.

Depressed? No. What about mood disorder? Paxil can help

Thu, 12 Apr 2007 15:52:58 -0400

The makers of antidepressants like Paxil don't care if you're not depressed. They want you to start taking antidepressants like Paxil even if you're having a not so good day. Depression may be too strong of a word but they are happy to treat you if you're having a mood disorder. It's kind of sad when women of child bearing age have to be under the microscope and cannot have feelings and must be treated (i.e. pay for pricey prescription drugs like Paxil) with antidepressants.

Doctors have been wisely reluctant to prescribe SSRI meds like Paxil to pregnant women. However, the drug companies don't want to be ignored and women of childbearing age are a demographic that they want taking antidepressants. According to the pharmaceutical companies - all pregnant women are depressed and should be taking Paxil-like drugs.

The Advocate Good Samaritan Hospital in Illinois continues to recommend that SSRIs be used to treat pregnant women despite recent warnings concerning birth defects and other life-threatening disorders in children born to mothers who took antidepressants during pregnancy. One has to wonder what their agenda is and how much research money they research from pharmaceutical companies peddling SSRI drugs like Paxil.

http://www.scoop.co.nz/stories/HL0704/S00105.htm