Prozac is an early antidepressant and the first drug in the class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs. It first came on the market in 1987 and was introduced by Eli Lilly as a new way to treat depression. Since Prozac first came out many other SSRIs have been introduced including generic forms of Prozac.

Prozac and its generic, fluoxetine, have continued to be among the most popular of all prescribed antidepressants and have helped many people struggling with depression and other conditions. There have been problems too, though, including an increase in suicidal thoughts in young people, a possibility of birth defects, dangerous withdrawal, and other serious and potentially life-threatening complications for people who take Prozac.

All About Prozac

Prozac, also known as the generic drug fluoxetine was approved by the U.S. Food and Drug Administration (FDA) in 1987 for the treatment of major depressive disorder. Fluoxetine has also been approved to treat other conditions like obsessive compulsive disorder, panic disorder and panic attacks, certain eating disorders including bulimia nervosa, and premenstrual dysphoric disorder (under the brand name Sarafem).

How it Works

Fluoxetine was the first drug made in the class of antidepressants called selective serotonin reuptake inhibitors. Depression and certain other conditions are associated with lower-than-normal levels of a neurotransmitter, or brain chemical, called serotonin. SSRIs treat these conditions by increasing the amount of serotonin in the brain. They do this by blocking the neurotransmitter’s reabsorption. They keep more serotonin in circulation.

Side Effects

Prozac has been used for decades with a lot of success for many people. However, there are side effects possible with taking this medication. The most common effects are not serious and should reduce with time as the body adjusts to the drug. Any symptoms that are severe or do not diminish should be reported to a doctor. The most common side effects of Prozac are nausea, dry mouth, sore throat, sleepiness and weakness, nervousness, a loss of appetite accompanied by weight loss, excessive sweating, sexual dysfunction, and shaking.

Severe allergic reactions are also possible with Prozac. If you have a serious reaction while taking this drug, you need to seek emergency medical attention. Signs of a serious allergic reaction include hives, itchiness, and a skin rash, fever, joint pains, swelling in the face and throat, trouble breathing, and difficulty swallowing. Other serious side effects that should be reported immediately include severe muscle stiffness, a fast or irregular heartbeat, confusion, hallucinations, or seizures.

Suicidal Thoughts and Actions

In 2007 the FDA announced that all antidepressants, including Prozac, would be required to add a black box warning to labels regarding the potential risks of suicidal thoughts and behaviors. A black box warning is the FDA’s most serious warning label, reserved for those possible risks that may be life-threatening or severe.

Antidepressants including SSRIs have been found to increase the risk that children and young adults in their early 20s will have suicidal thoughts and that they may act on those thoughts. Although rare, studies have shown that this risk may be as much as double in young people taking antidepressants. For adults, taking antidepressants reduces the risk of suicide. Why this is opposite for children and adolescents is not understood, but doctors are cautioned to only prescribe a drug like Prozac to a young person if other treatments have not worked and the benefits outweigh the risks.

Serotonin Syndrome

In 2006 the FDA issued a warning about the risk of a condition called serotonin syndrome in people taking Prozac and other SSRIs, especially when taking them with another type of antidepressant called an SNRI. This syndrome occurs when too much serotonin floods the brain. To treat depression without risking this condition requires a careful balance. Too little serotonin and the symptoms of depression are not relieved. Too much and this life-threatening syndrome may occur.

Anyone taking Prozac or other SSRIs should watch for the signs of serotonin syndrome and seek immediate treatment for it. Symptoms include hallucinations, agitation, overheating, an abnormal heartbeat, poor coordination, nausea, diarrhea, vomiting, and loss of consciousness or coma.

Birth Defects

Also released by the FDA in 2006 was the warning that Prozac and other SSRIs could cause a serious condition in newborns called persistent pulmonary hypertension of the newborn, or PPHN. The alert came after a study showed that babies born to mothers taking Prozac or another SSRI after the 20th week of pregnancy were up to six times more likely than other babies to be born with PPHN. This condition occurs when a newborn has not adapted to breathing outside the womb and it can be fatal or cause long-term consequences if not treated right away.

Studies have also found that there is a connection between a mother using Prozac during pregnancy and an increased risk for birth defects in her newborn. Before a 2015 study there had already been some reports of birth defects that may have been linked to antidepressant use in pregnant women, but more recent investigations by the Centers for Disease Control and Prevention have confirmed the connection.

The research found that fluoxetine was linked with two specific birth defects: heart defects of the right ventricle obstructing blood flow and craniosynostosis, a skull defect. Other defects found to be connected to SSRI use included other heart and skull defects, and two types of abdominal wall defects. Although there is an increased risk for pregnant women seeing these defects in their child if they use SSRIs, the overall risk is still low. Recommendations are for women and their doctors to weigh the benefits and risks before deciding whether or not to use an antidepressant during pregnancy.

Lawsuits

Fluoxetine has been on the market for nearly 30 years, and yet warnings about some of the most serious risks of taking it didn’t come out until 15, 20, or more years after people started using it. This means that too many people have suffered because of the increase in suicidal thoughts, the birth defects, and the serotonin syndrome.

Because of all these risks and harms caused by Prozac, thousands of lawsuits have been filed against Eli Lilly over the years. People have sued because of the behavioral changes caused by serotonin syndrome, because of loved ones lost to suicide, and because of birth defects in infants. These cases may be consolidated into class action suits and you could be a part of them if you too have been harmed by the use of Prozac.