Prozac

Prozac (fluoxetine) was the first selective serotonin reuptake inhibitor (SSRI) antidepressant approved to treat depression. Prozac is also approved to treat other mental health conditions including obsessive compulsive disorder, premenstrual dysphoric disorder, bipolar disorder, and anxiety disorders.

Quick Summary
Prozac

Prozac (fluoxetine) is the first member of selective serotonin reuptake inhibitor (SSRI) class of antidepressants.

Prozac is approved to treat mental disorders including:

  • Major depressive disorder
  • Obsessive-compulsive disorder
  • Panic disorder
  • Bulimia
  • Bipolar I disorder

It has also been used to treat other conditions including Premenstrual dysphoric disorder and pain conditions and is approved for use in children and adolescents for some disorders.

It was approved in 1987 and was the first of the “new” antidepressants which had fewer side effects than older, more traditional drugs and is still prescribed an estimated 25 million times each year.

Prozac Side Effects

Prozac may cause common side effects such as nausea, headache, sexual dysfunction, insomnia, anxiety, dizziness, dry mouth, weight gain or loss, and constipation or diarrhea.

Prozac may also cause more severe side effects or complications which may be serious or life threatening including:

  • Serotonin Syndrome – caused by an excess of serotonin in certain areas of the brain and may have symptoms such as changes in mental function, blood pressure, heart rate, muscle symptoms, fever or severe nausea, vomiting and diarrhea. Serotonin Syndrome may be fatal and should be treated as an emergency.
  • Suicide Risk – SSRIs may increase the risk for suicidal thoughts and behavior in children, adolescents, and young adults. Risk may be higher for patients with bipolar disorder or who have a history of suicidal behaviors. The risk may be worsened during the initial period of medication use or changes in dose and may subside over time but young patients should be closely monitored.
  • Birth Defects – increased risk of birth defects may include miscarriage, heart defects, persistent pulmonary hypertension of the neonatal (PPHN), physical abnormalities such as brain, skeletal or abdominal malformations like anencephaly, craniosynostosis or omphalocele, developmental delays and other birth defects.

Severe side effects should be reported to a medical professional and may require emergency treatment.

Prozac Overview

Prozac (fluoxetine) is the first member of selective serotonin reuptake inhibitor (SSRI) class of compounds also called serotonin-specific reuptake inhibitors. It was approved in 1987 and was the first of the “new” antidepressants which had fewer side effects than older, more traditional drugs.

Prozac is manufactured by Eli Lilly and though it is the oldest SSRI, it is still the third most-prescribed antidepressant, given to about 25 million U.S. patients every year.

Prozac is approved to treat a number of conditions including:

  • Major depressive disorder
  • Obsessive-compulsive disorder
  • Panic disorder
  • Bulimia
  • Bipolar I disorder

Prozac works by increasing activity of Serotonin, a neurotransmitter or chemical messenger in certain areas of the brain.

Prozac is approved for use in children and adolescents for some conditions and has been used off-label for other disorders including premenstrual dysphoric disorder, pain syndromes and other conditions. While Prozac has helped many patients, it has caused serious side effects such as suicide and birth defects when taken during pregnancy.

Prozac Side Effects

Though the SSRIs have a lower side effect profile than older “tricyclic” medications which are non-specific, Prozac treatment is associated with a wide range of side effects.

Most Prozac side effects will be mild-to-moderate and will go away with time, however other side effects may be more serious or life-threatening.

Common Prozac side effects may include:

  • Nausea
  • Dry mouth
  • Headaches
  • Diarrhea
  • Sexual dysfunction
  • Agitation
  • Nervousness
  • Restlessness
  • Increased sweating
  • Weight gain
  • Drowsiness
  • Insomnia

Higher doses of Prozac may increase the frequency or severity of side effects. Some side effects are potentially fatal.

Prozac Serotonin Syndrome

Prozac’s effect on increasing levels of serotonin in the brain and body may result in serious side effects or complications. Serotonin Syndrome is an acute clinical condition which can develop quickly and cause life-threatening complications. Serotonin Syndrome occurs when the patient’s serotonin levels rise to the point of physiologic toxicity.

Symptoms of serotonin syndrome may include:

  • high blood pressure
  • increased body temperature
  • increased heart rate
  • unexpected muscle contractions
  • changes in cognitive function
  • loss of consciousness
  • seizure

Serotonin Syndrome from Prozac may be more likely when used in conjunction with other serotonergic medications or supplements but can occur alone.

Prozac Increased Suicide Risk

In 2004, the FDA required that all SSRI antidepressants including Prozac include a “black box warning” regarding an increased risk of suicide. A black box warning is the most serious advisory given for the use of a medication and is placed in a black bordered box at the top of prescribing information.

Prozac may increase the risk of suicide in children, adolescents and young adults. This risk may be worsened if the patient has bipolar disorder or a history of suicidal behaviors and may be most pronounced when dosing is started or changed.

Suicidal ideations and behavior may become evident within the first one or two months of an initial Prozac treatment. Harmful effects can also occur as a result of attempting consecutive antidepressant therapies, such as using Prozac after using a different SSRI antidepressant.

Prozac During Pregnancy

The FDA has classified most SSRI medications, including Prozac as Pregnancy “Category C” medications. This designation means that Prozac can cause harm to animals or humans in large doses, but the effects on unborn children is not yet proven. As a result, it may not be safe for use during pregnancy.

There have been a number of reports and research experiments to suggest that Prozac and numerous other antidepressant medications can cause problems to either the mother or child when used during pregnancy. Some of the issues encountered when using Prozac for antidepressant treatment during pregnancy are persistent pulmonary hypertension of the newborn, heart defects, physical deformities, autism spectrum disorder, and premature birth.

Prozac Lawsuits

Eli Lilly has already faced and settled a number of Prozac lawsuits. Many plaintiffs have claimed that Eli Lilly failed to give consumers adequate warning of the serious complications of using Prozac. People or loved ones of those who were harmed after taking Prozac should seek legal assistance.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.