Prozac (fluoxetine) is an SSRI antidepressant which is used to treat depression and other mental disorders such as OCD and panic disorders. Prozac’s manufacturer, Eli Lilly has faced thousands of Prozac lawsuits for suicidal behaviors, birth defects and injuries caused by the medication.
Prozac is the best-known and oldest member of the SSRI antidepressant medication class and has a long history of problems associated with its use. Eli Lilly, manufacturer of Prozac, has faced thousands of lawsuits, beginning in the 1990s, in federal, state and local courts throughout the U.S. for injuries caused by the drug. Lilly has paid $millions in settlements and awards for damages in cases involving birth defects, suicide and other serious side effects or injuries.
Drug Warning: Prozac
|Classification||serotonin-specific reuptake inhibitor (SSRI) antidepressant|
|Manufacturer||Eli Lilly & Co.|
|Dosage form(s)||10mg capsule
90mg XL capsule (weekly)
20mg/5ml oral solution
|Alternative dosage forms||In combination with olanzepine as “Symbyax” capsules
Under brand name “Sarafem” for Premenstrual Dysphoric Disorder
|Normal dosage||10 to 80mg daily
Equivalent amount weekly as XL capsules
Prozac is a selective serotonin reuptake inhibitor (SSRI) which treats depression and other mental disorders. It works by increasing neurotransmitter, serotonin, levels in mood centers and certain areas of the brain.
Prozac is approved to treat:
- Major depressive disorder (MDD) in adults and children
- Obsessive-compulsive disorder (OCD) in adults and children
- Bulimia nervosa
- Panic disorder (PD)
- Premenstrual dysphoric disorder (PMDD)
When combined with the atypical antipsychotic medication Zyprexa (olanzepine), Prozac is approved to treat:
- Bipolar I disorder or Manic depression in adults and children over 10 years of age
- Recurrent or refractory Major depressive disorder
Prozac Side Effects
Like all medications, Prozac may cause side effects. Most side effects are mild to moderate and will go away over time. Other Prozac side effects are more severe, may be more persistent, serious or even life-threatening.
Common side effects of Prozac:
- Decreased libido
- Dry mouth
More severe side effects of Prozac:
- Suicidal thoughts and behaviors
- Increased risk of bleeding
- Serotonin syndrome
- Discontinuation syndrome
- Birth defects
- Hypersensitivity reactions
- Heart rhythm changes
- Low sodium levels
Prozac was the first of the “newer” antidepressants, now called SSRIs. It was designed to be effective with fewer side effects than older types of antidepressants and while it represented a huge improvement in treatment of depression, the drug has had a significant history of troubles and has been the subject of numerous warnings by the U.S. Food and Drug Administration (FDA).
Prozac Suicide and Violence
In May of 1990, the FDA issued safety alerts regarding unreported side effects of Prozac including suicidal and violent behavior, episodes of bulimia, strokes, and hemolytic anemia in children, adolescents and young adults (under 24). Some of these events were the subject of widespread media coverage and controversy.
Prozac Black Box Warning
In 2004, the FDA began requiring that all SSRI and other antidepressants include a “black box” warning on all package labeling and prescribing information. A black box warning is the highest level of alert that can be issued by the FDA. Prozac’s black box or boxed statement warns of the potential for increased suicidal behavior and increased risk of suicide, particularly in children, adolescents and young adults. In 2007, the FDA required that the Prozac black box warning be updated to state that the risk of suicidal thoughts and behaviors was most prevalent in the initial treatment period but longer that previously thought, lasting for one to two months after the drug was started.
Prozac Birth Defects
In 2006, prescribing information was changed to include information about the risk of birth defects and autism which may affect unborn fetus when Prozac is used during pregnancy.
When taken during pregnancy, Prozac may cause:
- Coarction of aorta
- Septal defect
- Hypoplastic Left Heart Syndrome (HLHS)
- Pulmonary stenosis
- Transposition of great arteri
- Tetralogy of fallot
- Autism Spectrum Disorder
- Persistent pulmonary hypertension of the newborn (PPHN)
Prozac Serotonin Syndrome
In 2013, Prozac labeling was updated to include more information about Serotonin Syndrome and its risks, including the use of Monoamine Oxidase Inhibitor (MAOIs) and other medications which could increase the effects of serotonin.
- Agitation and restlessness
- Muscle rigidity
- Muscle twitching
- High fever
- Heavy sweating
- Irregular heartbeat
- Loss of consciousness
Serotonin syndrome may be serious or life-threatening. Sudden or rapidly worsening symptoms should be treated as a medical emergency.
The first Prozac lawsuits were filed as early as the 1990s and since then, Eli Lilly has faced thousands of lawsuits and paid $millions in awards, settlements and fines for injuries caused by Prozac. Most lawsuits have already been settled and there are no new Prozac lawsuits on the horizon but Prozac or other forms of fluoxetine may continue to pose potential risks to patients who take the medication. As such, Prozac attorneys and lawyers will remain watchful.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.