Prozac, which was developed by Eli Lilly, is one of the earliest antidepressants in the class called selective serotonin reuptake inhibitors, or SSRIs. Millions of people rely on these drugs to treat depression and anxiety, and many of them tolerate Prozac well. Others, however, have been victims of some uncomfortable, disruptive, and in some cases very severe and devastating side effects.

Prozac side effects, which range from mild symptoms to life-threatening things like suicide, have disrupted many lives. They have also led to a number of lawsuits against Eli Lilly. Much of the problem stems from the fact that the warnings about side effects did not appear for many years, even decades, after the drug came on the market. Users feel they were not warned adequately and feel that Eli Lilly has been negligent in their experiences of side effects.

Prozac and SSRIs

Prozac is the generic drug fluoxetine and it is an early SSRI. The class of drugs has expanded greatly since these early medications designed to treat depression first came out. The U.S. Food and Drug Administration (FDA) first approved Prozac in 1987. It was approved to treat major depression, but later was also approved to treat anxiety disorders.

According to official indications Prozac may be used to treat depression in adults and children eight years old and older. It can be used to treat obsessive compulsive disorder, a type of anxiety disorder in adults and children seven and older. It can also be used to treat panic disorder and bulimia in adults. Fluoxetine has also been branded as Sarafem and approved to treat premenstrual dysmorphic disorder.

SSRIs like Prozac are thought to work as a treatment for anxiety and depression by increasing levels of serotonin in the brain. Serotonin is a neurotransmitter, a type of signaling chemical that is implicated in mood. By blocking how much of it is recycled, the amount of serotonin in the brain increases on Prozac.

Common Prozac Side Effects

As with other SSRIs, Prozac side effects are plentiful. For many patients these are mild and are worth the benefits of improved mood. Some people see that the symptoms lessen with time and become less severe or even disappear entirely. For others the side effects are not tolerable and they must switch to another type of antidepressant.

Most commonly reported with Prozac are sore throat, dry mouth, appetite loss and weight loss, nausea, sexual dysfunction, shaking and tremors, sleepiness, muscle weakness, and nervousness. Some people may experience an allergic reaction to Prozac, but this is not common. In addition to these side effects that are not considered serious, some patients may experience more severe symptoms caused by serotonin syndrome, withdrawal, suicidal thoughts, or even birth defects.

Suicidal Side Effects

One of the biggest concerns that have been seen with Prozac and other antidepressants is the side effect of increased suicidal thoughts and actions. This risk is seen only in young people, including children, teens, and adults up to the age of 24. The risk is also not common, but the consequences can be serious and have even led to deaths.

The FDA did not release a statement warning about this potential side effect until 2007, 20 years after Prozac first came on the market. Prozac and other similar medications now carry a black box warning, the FDA’s most serious type of warning, on the packaging label and insert.

Prozac is approved for certain uses in children and teens, but doctors and patients are warned to carefully weigh the benefits of the drug against the risk of suicide. They are also encouraged to carefully monitor the behaviors and attitudes of young people taking the drug to look for any disturbing changes that may indicate suicidal thoughts and a potential for suicidal actions.

Birth Defects

Another very controversial potential side effect of Prozac is birth defects and other complications of childbirth and development in the children of women who used the drug during pregnancy. A warning about this risk came from the FDA in 2006, as with the suicide warning, many years after the drug first came into use.

One potential and serious complication is called persistent pulmonary hypertension of the newborn, or PPHN. This condition occurs immediately after birth and can be fatal for the infant if not treated right away. A study found that women using Prozac in the second or third trimesters were at a six times greater risk of having a child born with PPHN.

Other studies looked at the incidence of birth defects and found that mothers who used Prozac or other SSRIs were more likely to have children born with them. The birth defects ranged from defects in the abdominal wall to problems with the skull or heart to spina bifida. Prozac in particular was found to be most linked to two defects: craniosynostosis, a skull defect and a defect of the right ventricle of the heart.

Serotonin Syndrome

Serotonin is the brain chemical that Prozac and similar drugs increases, but too much of it can be dangerous and can trigger serotonin syndrome. The FDA issued a warning about this in 2006 and stated that the risk was especially high in patients using two types of antidepressants. Serotonin syndrome is characterized by feelings of agitation, hallucinations, nausea, vomiting, diarrhea, overheating, an irregular heartbeat, poor coordination, loss of consciousness, and a coma. It needs to be treated right away or the consequences can be severe and lasting.

Withdrawal Side Effects

Prozac also has the potential to cause withdrawal symptoms in patients who stop taking it too suddenly. Withdrawal is usually associated with addictive drugs, and while Prozac is not considered habit-forming by experts, those who have experienced it disagree.

Withdrawal can cause side effects like irritability, headaches, anxiety, insomnia, nightmares, and other symptoms similar to what a detoxing drug addict experiences. Patients on any kind of antidepressant are strongly discouraged from trying to stop using it without a doctor’s guidance because of this withdrawal side effect.

Many of the side effects of Prozac are mild and well tolerated by those people who get the benefits of relief from depression and anxiety. On the other hand, many people have suffered over the years from the more severe side effects, and most of these were not brought to the attention of the public until 20 years after Prozac came into use.

Some of those patients have filed lawsuits against Eli Lilly claiming that the company failed in its responsibility to fully test the drug for side effects and to warn the public about them. You too may want to file a lawsuit to seek compensation for your pain and suffering.