Did you know this version of Internet Explorer is out of date?

To get the latest experience from our website, please upgrade your browser.

Have a drug or medical device concern?




Prozac is an SSRI antidepressant manufactured by Eli Lilly. The drug is linked to birth defects when taken during pregnancy.

Depression is one of the most common mental disorders in the United States, and pharmaceutical companies have responded with an ever-growing arsenal of antidepressants. But along with the increasing use and effectiveness of antidepressant drugs, many health care professionals have raised concerns over the adverse side effects and serious complications associated with their use.

There are many different classes of antidepressant medications. The current standard of treatment involves a drug class known as selective serotonin reuptake inhibitors (SSRIs). Scientists believe that depression can be triggered by a lack of the chemical serotonin, and these drugs essentially maintain higher levels of serotonin in the brain to correct the issue.

Fluoxetine, the first SSRI, was discovered by chemists Klaus Schmiegel and Bryan Molloy while they worked for the pharmaceutical company Eli Lilly. Lilly won FDA approval for the drug in December 1987 and it was marketed as Prozac soon after. Since that time, many other SSRIs have come on the market, including Citalopram (Celexa, Cipramil), Escitalopram (Lexapro, Cipralex, Seroplex, Lexamil), Fluvoxamine (Luvox), Paroxetine (Paxil, Aropax), Sertraline (Zoloft) and Vilazodone (Viibryd).

Despite the competition, Prozac and its generic equivalents remain popular and have become the third-most-prescribed antidepressant in the United States. In 2010, more than 24.4 million prescriptions for generic fluoxetine were filled in the U.S.

In addition to adult depression, the U.S. Food and Drug Administration (FDA) approved Prozac for the treatment of pediatric depression, obsessive-compulsive disorder, bulimia nervosa, panic disorder and premenstrual dysphoric disorder.

Overuse of Prozac and Common Side Effects

Researchers continue to study Prozac’s effects on the body, and new information about potential complications is still coming to light. One of the biggest concerns is that the drug is over-prescribed, unnecessarily subjecting patients to adverse side effects and possible withdrawal symptoms.

Patients taking Prozac may experience a host of side effects, including sexual dysfunction, dry mouth, nausea, headache, diarrhea, nervousness, restlessness, agitation, increased sweating, weight gain, insomnia and drowsiness.

Although antidepressants like Prozac are not technically considered to be addictive, at least in the sense of inducing cravings in patients, doctors say they do make users dependent. Drug dependency means that the body has adapted to a chemical to the point that it requires steady doses to normally function. Because of this, patients who abruptly stop taking antidepressant drugs are likely to experience withdrawal symptoms such as nausea, headache, dizziness and lethargy. Patients are warned to wean themselves off antidepressants slowly and under a doctor’s care.

High doses of SSRIs often increase the severity of side effects, and one particular side effect can be fatal. The onset of Serotonin Syndrome, a condition in which too much of the mood elevator is present in the brain, can occur within minutes, producing high blood pressure, hyperthermia, high body temperature and an increased heart rate that can lead to shock. Serotonin Syndrome can arise when SSRIs act alone or in conjunction with other medications.

Prozac Suicide Warning

Prozac is one of the few antidepressants approved for the treatment of depression in youths. Unfortunately, however, studies on children have linked the drug to increased suicidal thoughts and behavior. As a result, the FDA issued a public warning in October 2004, and two years later extended the advisory to include young adults as old as 24.

In 2007, the FDA took an even stronger stance. The agency required antidepressant manufacturers to update existing black-box warnings about the increased risks of suicidal thoughts and behavior during initial treatment, which the FDA defined as the first one to two months.

An FDA black-box warning is the most stringent precaution a drug can carry before it is pulled from the shelves. It takes its name from the black border that surrounds the warning information on the drug’s packaging. The agency often requires pharmaceutical companies to include a bold warning on drug packaging and patient instruction sheets if serious or life-threatening risks are associated with the drug’s use.

Prozac and Pregnancy

Pregnant women managing their depression with Prozac often face a difficult decision – either grapple with the potential dangers to mother and child if the depression is left untreated during pregnancy or continue taking the drug knowing there is a low but possible risk of harming their unborn children. SSRIs have largely been assigned a “C” grade for safety during pregnancy by the FDA. Drugs in this category have been known to harm animals in large doses, but the effects on unborn humans are not proven.

When taken during the last half of pregnancy, some research links Prozac to a rare but serious lung problem known as persistent pulmonary hypertension of the newborn (PPHN). This condition arises when a newborn’s circulatory system does not properly adapt to breathing outside of the womb. According to the National Institute of Mental Health, a study of pregnant women published in 2009 found that the use of certain antidepressant medications may also increase the risk for premature birth. Heart defects of the septum have also been reported in newborns.

Researchers are not only investigating physical birth defects that SSRIs have on fetuses, but the long-term neurological effects as well. In July 2011, a case study from the Archives of General Psychiatry linked the use of SSRIs during the first trimester of pregnancy to an increased risk of the baby developing an autism spectrum disorder (ASD).

In response to these and other studies, the FDA issued a December 2011 advisory stating that, “There are no adequate and well-controlled studies of SSRIs in pregnant women.”

Patients are encouraged to speak with their doctors and carefully consider whether taking Prozac is in their best interest. SSRI antidepressants certainly have an important role in treating depression, but their use does not come without risks. It’s up to the individual to learn as much as possible about Prozac and make an informed decision.