A Short History of SSRIs
SSRIs were first discovered in the 1980s but gained widespread acceptance in the 1990s and were often hailed as "miracle drugs." This was due to the belief that SSRIs were better tolerated than other antidepressants. SSRI antidepressants have arguably completely changed the way the western world thinks about mental health, with years of talk therapy being replaced by a simple pill. These drugs have been controversial since their introduction. As these drugs became more and more widely prescribed, criticism began to fall on the aggressive marketing techniques that pharmaceutical companies used to sell these drugs. Questions were raised about the overall effectiveness of these drugs. Some questioned whether the diseases they were prescribed to treat even actually existed.
SSRIs, Violence and Suicide
Shortly after the introduction of these drugs to the market, reports began to emerge linking SSRIs to violent behavior and even suicide among younger users.
In 2000, studies emerged showing possible evidence that SSRIs could induce hallucinations, aggression and violent behavior in children and teens taking these drugs. These studies and growing anecdotal evidence were alarming enough that in 2003, the British Government banned the prescription of several SSRIs for the treatment of depression in anyone under 18.
American legislators and regulators were slower to act, but in 2004, the FDA held hearings on the use of SSRIs in children. After the 2004 hearings, the FDA ordered the manufacturers of several SSRIs to place a "black box" warning in the label. A black box warning is the strongest warning label the FDA has authority to place on any package. The label on Zoloft and other related antidepressants warned doctors and parents to be alert for signs of aggression, anxiety, agitation or suicidal thoughts in patients taking these medications.
There have been multiple murders, suicides and violent actions in which SSRIs have been alleged to play a part. Among the most high-profile of these cases was the 1998 case of Brynn Hartman, the wife of actress Phil Hartman, who killed her husband and herself. She had been taking Zoloft at the time of her death, and her familysued Zoloft manufacturer Pfizer for wrongful death. The lawsuit was settled out of court for an undisclosed amount.
The relationship between SSRIs and violence came under significant public scrutiny after the tragedy at Columbine High School, when it became known that Eric Harris, one of the shooters, had taken the SSRI Zoloft. His parents brought a lawsuit against the drug's manufacturer in which they claimed that Harris had become obsessed with violence and suicide within weeks of beginning to take the drug.
The list of emotional and psychological side effects and warnings associated with SSRIs has continued to grow, and the FDA has ordered manufacturers to place a number of warnings on various SSRIs. These side effects now include increased risk of bone fractures and injuries, sexual dysfunction, increased feelings of depression and anxiety, panic attacks, mania, dissociative disorders, cognitive disorders and loss of contact with reality.
SSRIs and Birth Defects
After the warnings over radical behavior changes and suicidal became common knowledge, scientificreports began to emerge about a new and troubling set of side effects, namely birth defects. Aggressive marketing tactics by SSRI drug manufacturers have led to the increased use of SSRIs during pregnancy over the last decade.
A 2006 study published in the New England Journal of Medicine found that there was a significant association between taking SSRI medications during the first trimester of pregnancy and specific birth defects.
These birth defects included omphalocele, a birth defect in which a child is born with the intestines, liver, and occasionally other organs outside of the abdomen because of a defect in the development of the abdominal wall muscles. Additionally, the study found an increased risk of craniosynostosis, a birth defect in which the child’s cranial sutures close prematurely preventing normal brain and skull growth.
SSRIs have has also been associated with heart defects, including septal defects, a type of heart birth defect are often called "holes in the heart" , which in many cases will require surgical intervention to correct. There are several complex heart defects, including tetraology of fallot and hypoplastic left heart syndrome that can result in several surgeries and even a heart transplant. Prozac and other SSRIs have also been linked to these obstruction defects and can severely interfere with heart function.
These drugs have also been linked to persistent pulmonary hypertension, a potentially life-threatening condition in newborns that causes difficulty in breathing.
According to an FDA warning, children born to mothers who had taken SSRIs late in pregnancy were six times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy. Neonatal PPHN is a condition in which a baby is unable to properly process oxygen while breathing, a condition that can be immediately fatal and has potential long-term health consequences. The FDA recommended that physicians be extremely cautious in prescribing SSRIs to pregnant women and that the risks should be thoroughly discusses with women before SSRIs are prescribed.
Recently, a study conducted by the Karolinska Institute in Sweden found that SSRI use in late pregnancy was associated with PPHN. The study found that the increased risk applied to all SSRIs.
SSRI Lawsuits
Now, many people who have been injured by SSRIs are finding that their only recourse is to file a lawsuit. A lawsuit is often the only way to find compensation for the overwhelming financial burden that can be placed on families because of medical expenses, as well as the emotional distress that these drugs can cause.
If you or your child have been injured due to an antidepressant, the lawyers of Blizzard, McCarthy & Nabers are here to help. For a free case review from an experienced pharmaceutical lawyer, contact us by email or call us at 1-800-349-0127. All pharmaceutical liability cases are handled on a contingency basis.