Prozac was the first SSRI antidepressant medication used to treat depression. It is also approved to treat other mental health conditions including obsessive-compulsive disorder, premenstrual dysmorphic disorder, bipolar disorder, and anxiety disorders. Severe side effects caused by Prozac have been the basis of lawsuits filed against the manufacturer.

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What Is Prozac?

Paxil is the name brand for the generic medication fluoxetine and is a popular type of SSRI antidepressant. It was the first of the “new” antidepressants which had fewer side effects than older, more traditional drugs. It is approved for the treatment of depression and other mental disorders. Prozac is approved for use in children to treat some conditions.

How Does Prozac Work?

SSRI antidepressants, like Prozac, work by increasing the activity of a chemical messenger in the mood centers of the brain. This chemical messenger is the neurotransmitter, serotonin, which acts to regulate sleep and mood and may help provide the satiety or “satisfaction” sensation. Prozac increases the level of serotonin in the brain.

What Company Manufactures Prozac?

Prozac is the brand name for fluoxetine and is manufactured by Eli Lily and Company. Although Prozac is the oldest SSRI on the market, it is still one of the most prescribed antidepressants. It is estimated that approximately 25 million people are prescribed Prozac every year.

Is Prozac FDA-Approved?

Prozac gained FDA approval in 1987 and was the first SSRI to do so. Prozac was approved to treat depression in both adults and children.  Over time, it has been approved to treat additional conditions in adults and children.

What Is Prozac Prescribed To Treat?

Prozac is prescribed by doctors to treat conditions it is approved to treat as well as conditions for which it is not approved.

Prozac is approved to treat the following conditions:

  • Major depressive disorder
  • Obsessive-compulsive disorder
  • Bulimia nervosa (adult patients only)
  • Panic disorder (adult patients only)

What Is Major Depressive Disorder?

Major depressive disorder (MDD) is commonly referred to as depression. Depression is a disorder that affects a person’s mood, causing a constant feeling of sadness coupled with a loss of interest.

Symptoms of depression include:

  • Loss of interest in normal activities
  • Feelings of guilt or worthlessness
  • Excessive crying
  • Lack of energy
  • Loss of concentration
  • Changes in appetite
  • Changes in sleep patterns
  • Suicidal thoughts and tendencies

What Is Obsessive-Compulsive Disorder?

Obsessive-compulsive disorder (OCD) is a condition that causes people to have persistent and unwanted obsessions that make them feel compelled to repeatedly do something. These obsessions can be in the form of thoughts, ideas, or sensations. Repeated actions can include a variety of behaviors, such as handwashing, and may considerably impact someone’s day-to-day life. 

What Is Bulimia Nervosa?

Bulimia nervosa, or bulimia, is an eating disorder that may be life-threatening. Bulimia is characterized by the need to lose calories and prevent weight gain. This can present itself in the form of secretly binge-eating and then purging. People who have bulimia are typically preoccupied with their weight and the shape of their bodies.

What Are Panic Disorders?

Panic disorders are one variety of anxiety disorders. People with panic disorder experience unanticipated and recurrent episodes of heightened fear that are coupled with physical symptoms such as chest pain, shortness of breath, dizziness, heart palpitations, or abdominal discomfort or distress. Episodes caused by panic disorder are not induced by an obvious stressor. 

Is Prozac Prescribed To Treat Other Conditions?

Doctors may prescribe Prozac to treat conditions that it is not approved to treat. This is known as prescribing a medication “off-label” because it does not have FDA approval to treat that condition. This is allowed by federal law, but pharmaceutical companies are banned from advertising medications for the treatment of those conditions. These off-label uses may be provided for both children and adults.

Conditions for which Prozac has been prescribed off-label include:

  • Premenstrual dysphoric disorder
  • Binge eating disorder
  • Generalized anxiety disorder
  • Posttraumatic stress disorder

Prozac is sometimes prescribed off-label to treat pain conditions.

Prozac is approved to be prescribed in combination with olanzapine for certain conditions. These are:

  • Depressive episodes associated with Bipolar I (adults only)
  • Acute treatment of resistant depression (adults only in certain circumstances) 

Does Prozac Cause Side Effects?

Prozac, like most medications, causes side effects in some patients. Most of these side effects are mild and will go away on their own with time. However, some patients may experience severe side effects and should seek medical attention right away. These severe side effects are dangerous and may become life-threatening in some cases. High doses of Prozac may increase the frequency and severity of side effects.

Mild side effects caused by Prozac include:

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

Can Prozac Cause Severe Side Effects?

Prozac can cause severe side effects. These side effects should be reported to a healthcare professional immediately.

Severe side effects caused by Prozac may include:

  • Low sodium blood levels
  • Angle-closure glaucoma
  • Seizure

Prozac may cause side effects that are significant and may be life-threatening. These side effects have been the basis of lawsuits filed against the manufacturer.

These are:

  • Birth defects
  • Increased risk of suicide
  • Serotonin syndrome

Is Prozac Safe To Take When Pregnant?

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 are 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.

Prozac can have nonteratogenic effects on newborns. These are not birth defects and include the need for prolonged hospitalization, respiratory support, and need for feeding tube upon delivery.

Serious effects in newborns noted with Prozac may include:

  • Respiratory distress
  • Cyanosis
  • Apnea
  • Seizures
  • Temperature instability
  • Difficulty feeding
  • Constant crying
  • Irritability
  • Vomiting
  • Hypotonia
  • Hypoglycemia
  • Jitteriness
  • Tremor
  • Hypertonia
  • Hyperreflexia

Is Prozac Linked to Birth Defects?

Pregnant or nursing mothers face serious risks. Taking Prozac while pregnant carries the potential risk of birth defects and may be linked to serious complications in some pregnancies. 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 is associated with considerable neonatal mortality and morbidity.

Is It Safe To Take Prozac While Breastfeeding?

Prozac is excreted in breast milk and breastfeeding while taking Prozac is not recommended. Studies have shown no side effects in nursing infants, while other studies have shown the following symptoms in infants exposed to Prozac through breastmilk:

  • Increased crying
  • Disturbance in sleep
  • Vomiting
  • Watery stools

Mothers who are breastfeeding while taking Prozac should keep an eye out for severe colic, fussiness, and crying.

Does Taking Prozac Increase the Risk of Suicide?

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. The risk for suicide 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.

Does Taking Prozac Cause 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 that can develop quickly and cause life-threatening complications. Serotonin Syndrome occurs when the patient’s serotonin levels rise to the point of physiologic toxicity. It is more likely to occur if the SSRI is taken with other medications that also affect serotonin including treatments for migraine, cough suppressants, and certain herbal remedies.

Serotonin syndrome may include symptoms such as:

  • Unusually high fever
  • Increased heart rate and changes in rhythm
  • Loss of balance or coordination
  • Confusion and hallucinations
  • Seizures
  • Nausea
  • Vomiting
  • Unexpected muscle contractions
  • Loss of consciousness

In some cases, serotonin syndrome may be life-threatening. All medications should be discussed with a physician to avoid drug interactions.

Have Lawsuits Been Filed Because of Prozac?

Since its introduction, Prozac has been the subject of ongoing investigations from reports of adverse effects associated with its use. Eli Lilly, the manufacturer of Prozac, has successfully defended a number of lawsuits but has also settled multiple cases after claiming that the drug has an established efficacy and safety profile. Most Prozac lawsuits have been resolved or settled but a few cases may still remain in courts.

People or loved ones of those who were harmed after taking Prozac should seek legal assistance. 

What Types of Lawsuits Have Been Filed Regarding Prozac?

In addition to early claims of suicide or homicide, one of the most common issues resulting in a lawsuit after using Prozac are claims for birth defects. Prozac lawsuits have also claimed developmental disorders, such as autism, were the result of being prescribed during pregnancy.

Specific notable cases include:

  • In one Prozac lawsuit case, a SWAT team captain and police officer, Daren Alli, committed suicide after 4 days of taking Prozac. He had reportedly been suffering from mild symptoms of depression but Alli’s wife claimed that suicide was out of character for her husband. His wife also claimed that Alli would not have attempted treatment with the drug if he knew the possible risk of Prozac.
  • In one Prozac Birth Defect Lawsuit, a woman who took Prozac in 1996 during pregnancy gave birth to a son with a heart defect. The child required multiple cardiac surgeries over the course of several years, but the mother was unaware that the drug she had taken during her first trimester may have been responsible and did not file a lawsuit until 2013. Lilly unsuccessfully attempted to have the lawsuit dismissed in 2015 but the plaintiff was unsuccessful in court.
  • Prozac lawsuit claims have not been limited to the United States. In a Canadian Prozac lawsuit case, it was disclosed that Eli Lilly failed to report to the FDA the findings of two studies about psychological instability resulting from Prozac. In this Prozac lawsuit case, it was disclosed that if the studies were presented to the FDA, health professionals would be better aware of patients’ risks.

People who have been harmed by Prozac have stated that they would not have agreed to treatment if they were aware of the potential issues. Eli Lilly has been accused of failing to warn the public about possible complications.

What Prozac Lawsuit Settlements Have There Been?

Over 300 Prozac lawsuits have been addressed by the court systems including 30 lawsuits that were settled for an estimated $50 million. These lawsuits had largely been filed by people who claimed the medication caused the user to commit or attempt to commit murder or suicide. An additional 75 federal cases and other cases in courts across the country were resolved by dismissal or private settlements.

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


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