Prozac is one of the most well-known and recognizable of all antidepressant medications. It is also one of the earliest selective serotonin reuptake inhibitors, or SSRIs, a class of drugs that improves mood by balancing brain chemicals. Eli Lilly developed Prozac, generic name fluoxetine, and first brought it onto the market in 1987 after being approved by the U.S. Food and Drug Administration (FDA).
Since 1987 Prozac has been a big seller, but there have also been thousands of Prozac lawsuits brought by patients or parents of patients who suffered some terrible side effects. Although the drug has been linked to birth defects, the main source of lawsuits is the fact that Prozac increases the risk of suicidal thoughts and behaviors in children, adolescents, and young adults. The FDA implemented a required label warning about this, but not until the antidepressant had been on the market for years.
What is Prozac?
Fluoxetine, the generic form of Prozac, which is available through several drug companies, was first developed and tested by Eli Lilly. The FDA approved its use for the treatment of depression in 1987 and has since approved it to be used in treating some anxiety disorders. Doctors may also prescribe it off-label for things like premenstrual dysmorphic disorder and eating disorders. It is not approved for use in anyone under 18, although doctors may use discretion in prescribing it.
Prozac is an SSRI, a type of drug that blocks the reabsorption of serotonin, a brain chemical that plays an important role in regulating mood. Like other antidepressants, Prozac can take several weeks to work and comes with some common, usually not serious, side effects. These may vary by individual and usually diminish with time on the medication. Some possible side effects include nervousness, dry mouth, nausea, sleepiness, a sore throat, weight loss, sweating, shaking, and sexual dysfunction.
Prozac and Suicide
In addition to the more common side effects, which aren’t usually serious or persistent, some patients taking Prozac have experienced rarer, but much more serious adverse events. One of these has spurred a number of Prozac lawsuits as well as lawsuits against companies making similar antidepressants. These medications have been found to increase the risk that a young person will experience suicidal thoughts and even act on those thoughts committing self-harm or attempting suicide.
First on the market in 1987 it didn’t take long for reports of suicide in young patients to come to light. Evidence, however, was slower in coming and the first official warning about the risk didn’t come out until 2004. Because there was this issue and little information about it initially, a lot of young people suffered and many even died from suicide after taking Prozac. The parents of many of these young people have filed lawsuits to seek compensation.
The FDA Warning
The FDA issued several warnings about the connection between antidepressants like Prozac and suicide, but these did not come until more than a decade after Eli Lilly started selling the drug to the public. The first warning came in 2004 when the FDA shared data from studies that indicated children taking antidepressants may actually become more suicidal. Two years later that warning was updated to include the most recent research which found that the at-risk population extended from childhood to 24 years old.
The FDA warnings also included the requirement that drug companies like Eli Lilly change their antidepressant packaging labels to include a black box warning about suicide. This is the strongest warning that the FDA requires. In 2007 the agency again updated the requirement and stated that the black box must also include the fact that the increase in suicidal thoughts and behaviors can occur in young people even during the first month or two of treatment with an antidepressant.
The potential for suicidal thoughts and actions has been the number one reason for Prozac lawsuits filed against Eli Lilly. The number of cases started taking off in 1990 with plaintiffs seeking millions of dollars in compensation and punitive damages. Although these early cases varied by individual plaintiff, most of them accused Eli Lilly of failing to fully test Prozac before it hit the market and of being negligent in the violent and suicidal behaviors of some of the users. The plaintiffs and their lawyers also accused Eli Lilly of making fraudulent and misleading claims about the safety of the antidepressant.
Many of these early cases relied on the evidence from a study conducted by Harvard researchers. This study looked at six patients, none of whom had exhibited any suicidal behaviors before taking Prozac. All of them became suicidal only after taking the drug. The results of the study concluded that anywhere between two and eight percent of people on the drug could become suicidal.
Not all suicide lawsuits against Eli Lilly turned out in favor of the plaintiffs. Some were consolidated into groups of hundreds in multidistrict litigation cases, including one in Indiana where the drug company is headquartered. Not all of the information about settlements has been made public, but it is thought that Eli Lilly has paid at least $50 million to settle about 30 cases. Since the 2004 FDA warning about suicide, the number of cases filed has slowed down.
Another issue with Prozac that may lead to even more lawsuits is the possibility of birth defects. Several antidepressants have now been linked to birth defects and other health conditions in newborns and children. In 2006 the FDA made an official warning about one of these, called persistent pulmonary hypertension of the newborn, but has not yet made official warnings about birth defects.
Even so, reports from individuals and evidence from studies show there is most likely a link between taking drugs like Prozac during pregnancy and birth defects. The studies that show this connection came long after the drug came on the market so women went for years without really understanding the full risks. It is possible that as more evidence comes to light and as more studies are conducted, that lawsuits over Prozac will begin to increase again.
If you took Prozac or someone you love did, and you or that person was harmed irreparably, you could have a case to make against Eli Lilly. Whether you lost a loved one to suicide or have a child that will always have to live with the consequences of a birth defect, it’s possible that the drug maker could be found negligent. A lawyer can help you decide if your case is strong and what you can do next to seek compensation and justice.