Anti-Depressants & Suicide/Birth Defects (Celexa, Effexor, Lexapro & Paxil)
Products liability cases involving modern antidepressants in the class known as Selective Serotonin Reuptake Inhibitors ("SSRIs") have enjoyed a relatively consistent, if intermittent, place in the media spotlight since the turn of the millennium. The SSRI group includes Prozac, Paxil, Zoloft, Luvox, Celexa, and Lexapro, and there have been a number of events thrusting these drugs into the spotlight, including two of the more prominent cases: that of 12-year-old Christopher Pittman, who killed his grandparents while he was experiencing what was alleged to be a violent reaction to Zoloft and Paxil; and that of 60-year-old Donald Schell, who killed his wife, their daughter, their granddaughter, and then himself after taking only two doses of Paxil. The former resulted in a murder conviction and thirty-year jail sentence in South Carolina, while the latter resulted in a civil verdict of approximately $8 million in Wyoming federal court against the maker of Paxil, GlaxoSmithKline.
The deadly effects of SSRIs on children and adolescents have been well-documented: the potential to initiate or exacerbate depression or even cause suicidal thinking or behavior. Several manufacturers began sending out "Dear Dr." letters warning physicians of these risks in 2003 and 2004. By January 2005, manufacturers of SSRIs – and a few other modern antidepressants not technically considered SSRIs (e.g., Effexor, Wellbutrin, Cymbalta) – began warning of the risks in a black box warning contained on the labeling for each of the drugs. In 2006, GlaxoSmithKline warned doctors of the increased risk of suicide in all age groups for Paxil. In 2007, the black box warning was extended to those beyond their adolescent years, all the way up to age 25, for all antidepressant drugs.
Lawsuits over suicidal injuries allegedly caused by these drugs continue on at least two notable fronts. First, in In re Paxil, a Mass Tort Program in Philadelphia, Pennsylvania, there remain several cases involving consumers who either attempted or committed suicide allegedly as a result of Paxil. On another front, the Multi-District Litigation entitled In re Celexa and Lexapro Products Liability Litigation, MDL No. 06-md-01736-RWS, there are currently more than forty cases involving suicidal injuries allegedly caused by Celexa or Lexapro pending in the Eastern District Court of Missouri. Our firm is lead/liason counsel in both litigations.
More recently, on August 11, 2009, the British Medical Journal published an article detailing the results of a study aimed at measuring the association between modern antidepressants (Prozac, Paxil, Zoloft, Celexa, Lexapro, etc.) and increased suicidal thinking and conduct. August 11, 2009 BMJ Article. Although the study results are just now being published in a medical journal, they were first reported to the FDA in November 2006, following the FDA's collection of clinical trial data from all of the major antidepressant manufacturers. The study was conducted by – and the current articled authored in part by – Marc Stone and Lisa Jones, who are medical officers at the FDA. Nov. 2006 FDA Memo and Attached Report by Stone & Jones
The British Medical Journal article concludes that "[r]isk of suicidality associated with use of antidepressants is strongly age dependent." The article explains that the increased risk for suicidality and suicidal behaviour among adults under 25 approaches that seen in children and adolescents," while "the net effect seems to be neutral on suicidal behaviour but possibly protective for suidical ideation in adults aged 25-64." And the researches posit a "protective" effect for persons aged 65 and older.
Significantly, Table 5 in the article clearly shows that Celexa (citalopram) and Lexapro (escitalopram) carry a more than two-fold increased risk of "suicidal ideation or worse" compared to placebo for all adults.
Notably, the article excludes a table that appeared in the original report to the FDA, which showed figures for all adults for "suicidal preparation or worse," demonstrated that Paxil (paroxetine) carries a 2.76 increased risk, and that Lexapro carries a 5.67 increased risk.
The most troubling part about the numbers is that they are not readily available to the physicians who prescribe these drugs. Indeed, current antidepressant labeling discloses the increased risk of suicidality for those aged 25 and under but stops short of articulating any association for other age groups. 2009 Lexapro Prescribing Information
Still, some physicians continue to fail to warn their patients of the dangers of anti-depressants despite the specific and bold warnings on these drugs to carefully monitor patients for worsening depression and suicidality. Even the drug manufacturers admit that it is absolutely necessary for patients' families to closely monitor patients for any changes in behavior after beginning or changing a dose with antidepressant drugs.
These medications may help some people suffering from major depressive disorder; however, whether or not you believe these drugs are effective, it is malpractice to fail to warn a patient about the risks of suicide associated with these drugs and to monitor patients for changes in their behavior.
Without warnings to patients and families, patients would be under the sometimes mistaken belief that it is their underlying condition causing their anguish as opposed to the drug they are taking. Suicide is a horrible way to lose a loved one, but is especially cruel when the suicide is caused by a drug and a doctor's failure to warn of the risks of that drug.
In addition to potential suicidality, recent research has raised concerns about the increased risk of birth defects as a result of pregnant women taking these drugs. Since September, 2005 information has been emerging that Paxil may cause birth defects, including
- cardiac (heart)
- pulmonary
- PPHN (lung)-
- neural-tube defects (brain and spinal cord)
- craniosynostosis (abnormally shaped skull)
- infant omphalocele (abdominal wall defects)
- club foot (one or both feet turn downward and inward)
- anal atresia (complete or partial closure of the anus)
Several of these defects have now been linked with other antidepressants such as Zoloft, Celexa, Effexor, Lexapro, Symbyax and Prozac, as well.
The FDA, through a public health advisory, has concluded that exposure to paroxetine in the first three months of pregnancy may increase the risk for congenital malformations, specifically cardiac malformations -- like Septal Defects -- including Atrial and Ventricular Septal Defects.
An atrial septal defect is a hole in the wall between the upper chambers of your heart. Large atrial septal defects can damage your heart and result in a shortened life span. Surgery is usually necessary to repair atrial septal defects.
A ventricular septal defect is an opening in the ventricular septum, or dividing wall between the two lower chambers of the heart known as the right and left ventricles. A ventricular septal defect allows oxygen-rich blood to pass from the left ventricle through the opening in the septum, and then mix with oxygen-poor blood in the right ventricle. Most babies with ventricular septal defects need to have surgery to repair the defect. which are repaired early in life don't have any significant long-term problems.
On top of the risk of septal defects is the risk of persistent pulmonary hypertension (PPHN) for those mothers who ingested Paxil during their third trimester. A study published the The New England Journal of Medicine concluded that the rate of PPHN in babies whose mother used an SSRI antidepressant, like Paxil, after the 20th week of pregnancy was six fold over those babies whose mothers did not take an antidepressant.
At Pogust Braslow & Millrood, protecting our clients is our primary goal. We recognize that drug companies are under an obligation to warn about the known risks of their products. When they fail to do so, they may be held responsible for the injuries or deaths that are the consequence of their inaction. In addition, doctors may be responsible when they prescribe a medication for an unapproved condition or fail to warn or monitor regarding a particular risk and the patient suffers a serious side effect.
If someone you love has attempted or committed suicide, or you ingested Paxil while pregnant and your child has a birth defect, you should immediately contact the attorneys at Pogust Braslow & Millrood, where Protecting Consumers Is Our Primary Goal. Just fill out this form, click here to send us an email or call us at (610) 941-4204.
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