Prozac has been linked to serious side effects, including violent behavior, suicidal thoughts or actions, and an increased risk of birth defects if the drug is taken during pregnancy.
If you or a loved one dealt with any of these side effects, you may have grounds for a Prozac lawsuit. Filing a lawsuit might allow you to recover compensation for all medical expenses caused by the drug’s side effects, along with lost wages and pain and suffering.
O’Connor, Acciani & Levy’s defective drug attorneys know how to build a defective drug case and aggressively pursue all of the compensation you deserve. Schedule a free, no obligation legal consultation today. We will not charge legal fees unless you receive compensation.
BIRTH DEFECTS FROM PROZAC
The antidepressant Prozac has been on the market since 1987 when it was approved by the U.S. Food and Drug Administration (FDA).
This medication is known as a selective serotonin reuptake inhibitor (SSRI). These types of drugs are the most commonly prescribed antidepressants, and they work by blocking the reabsorption of serotonin, which increases serotonin levels in the brain.
While Prozac and other SSRIs can cause side effects like dry mouth, drowsiness and agitation, they have also been linked to severe birth defects when taken by pregnant mothers, including:
- Persistent pulmonary hypertension (PPHN) – Hypertension is another way of saying high blood pressure. This can be life-threatening for a newborn because it decreases the body’s supply of oxygen.
- Anencephaly – This is a birth defect that causes a baby to be born missing parts of his or her brain or skull.
- Isolated ventricular septal defects – This occurs when there is a hole in the wall the separates the two chambers in the heart. This can cause high pressure in the heart and reduce the body’s supply of oxygen.
- Obstruction of the right ventricular outflow tract – This is when there is a blockage of the right ventricular outflow tract, which could lower the body’s oxygen supply.
- Pulmonary stenosis – This is a blockage of blood flow from the right ventricle to the pulmonary artery. This is the result of a narrowing of the right ventricle.
- Transposition of the great arteries – This occurs when the aorta is connected to the right ventricle and the pulmonary artery is connected to the left ventricle. This is the opposite of the way the heart is supposed to work.
- Tetralogy of Fallot – This is a combination of four heart defects affecting the structure of the heart and reducing the flow of blood from the heart to the rest of the body.
- Omphalocele – This occurs when the baby’s intestines or other organs are outside of the body because of a hole in the belly button.
- Craniosynostosis – This is when two or more bones in the skull fuse together before they are supposed to. This changes the growth pattern in the skull.
- Hypoplastic left heart syndrome – This is when the left side of the heart does not form correctly.
If you took Prozac during pregnancy and your baby suffered any of these birth defects, contact our attorneys today. We can determine if you have grounds for a Prozac lawsuit.
Our class action lawyers can manage every aspect of the legal process, including the investigation, building a case, negotiating compensation and representing you at trial.
RESEARCH ON BIRTH DEFECTS FROM SSRIS
Research has consistently shown a link between Prozac and other SSRIs and severe birth defects in children from mothers who took these medications during their pregnancies.
In February 2006, The New England Journal of Medicine (NEJM) published a study about the risk of PPHN in newborns if their mothers took SSRIs during pregnancy. Researchers discovered a six-fold increase in PPHN among babies whose mothers took an SSRI after 20 weeks of pregnancy.
In June 2007, the same journal published another study about the risk of birth defects when mothers took SSRIs like Prozac during their pregnancies. Researchers found a statistically significant association between the use of SSRIs and birth defects like anencephaly, craniosynostosis and omphalocele.
In 2008, Pharmacoepidemiol Drug Safety published a study analyzing previously published research on the association between SSRI use and PPHN. Researchers analyzed data on babies born in Sweden from 1997 to 2005.
They found the risk of PPHN was lower than previously described in the literature, but they concluded there was an increased risk of respiratory problems after SSRI use during pregnancy and PPHN could be a rare issue associated with these respiratory problems.
The British Medical Journal published a study in 2009 showing an increase in septal heart defects among children born from mothers who took SSRI drugs early in their pregnancies.
Another study from 2011 revealed Prozac was associated with an increased risk of isolated ventricular septal defects. Although the risk of this defect is small, researchers said doctors should not consider Prozac as the first option when prescribing an SSRI to a pregnant woman. This study was published in Obstetrics and Gynecology in July 2011.
In January 2017, the British Medical Journal published a study from the Universite do Montreal saying antidepressants could increase the risk of various types of birth defects, including:
- Cardiac issues
- Craniofacial problems
- Digestive defects
- Respiratory defects
If you think your baby’s birth defects were a result of SSRI use during pregnancy, you may have legal options.
FDA WARNING ABOUT PPHN
Research about birth defects, particularly the NEJM study from 2006, led the FDA to release a drug safety communication in December 2011 saying the FDA was updating the public about the risk of PPHN caused by taking SSRIs during pregnancy. The communication also said the NEJM study provided the rationale for the update to the labels of SSRI medications about a possible increased risk of PPHN.
The FDA said it was still too early to make any conclusions about the potential link between Prozac and other SSRIs and hypertension in newborns. Patients should discuss the benefits and risks of taking an SSRI during pregnancy with their doctor. They should not stop taking one of these medications without talking to their doctor first.
The communication notes that PPHN sometimes needs to be treated with a mechanical ventilator to increase oxygen levels. In severe cases, PPHN can cause damage to organs, including the brain.
PROZAC AND SUICIDE
Not long after it came on the market in 1987, Prozac lawsuits were filed claiming the drug caused violent, aggressive or suicidal thoughts or behaviors.
Many of these cases relied on a report that was published in the American Journal of Psychiatry in February 1990. Researchers studied six patients who began displaying suicidal tendencies when they started taking Prozac. The lead researchers predicted 1.9 to 7.7 percent of Prozac users were at risk for mania, obsession with suicide and violent behavior.
Lawsuits continued throughout the decade. However, people stopped filing lawsuits after the FDA released a public health advisory in 2004 alerting the public that Prozac would have a black box warning about the risk of suicide.
A black box warning is the strictest warning that can be added to prescription drugs. These warnings alert patients and medical professionals there is reasonable evidence of an association between the drug and serious hazards.
The warning on the Prozac label says antidepressants increase the risk of suicidal thinking and behavior in children, adolescents and young adults. Anyone who is considering using this drug needs to balance that with the potential risks. Doctors should carefully monitor patients for suicidality or unusual changes in behavior.
If your loved one suffered suicidal thoughts or actions while taking Prozac, contact our firm about potentially filing a Prozac lawsuit.
Hundreds of lawsuits were filed in the late 1980s and throughout the 1990s alleging Prozac caused suicidal thoughts or actions or violent behavior. The lawsuits alleged failure to properly warn doctors and consumers about the dangers of the drug.
Some were combined into a multidistrict litigation (MDL) in the Southern District of Indiana. An MDL is a legal action composed of multiple cases that make similar allegations.
Many Prozac lawsuits about suicidal or violent actions were resolved in undisclosed settlements. However, there are reports that Prozac manufacturer Eli Lilly settled dozens of these lawsuits by paying out more than $50 million.
After the FDA warned of a possible connection between SSRI drugs and PPHN, people began filing lawsuits over birth defects they claimed were caused by Prozac.
One lawsuit was filed by a woman who took Prozac during her pregnancy in the mid-1990s. The lawsuit claimed the drug caused her son to be born with a congenital heart defect. Her lawsuit failed because she could not find an expert witness to testify that there was a connection between Prozac and birth defects.
If you believe you have grounds for a Prozac lawsuit, contact our firm today to discuss your situation with a qualified attorney.
CONTACT US TO SCHEDULE A FREE LEGAL CONSULTATION
Prozac has been linked to dangerous and potentially life-threatening side effects. If you or a loved one has suffered any of these side effects, you may have legal options.
Contact a class action lawyer from our firm for a free consultation. We can help you determine if you can file a Prozac lawsuit to try to obtain compensation for the physical, financial and emotional effects of your injuries.
Your consultation is free and we will not charge legal fees unless you recover compensation.