Prozac Lawsuit Lawyer
Please note: Our law firm no longer accepts Prozac cases.
A selective serotonin reuptake inhibitor (SSRI), Prozac has been linked to severe birth defects when taken by a woman in the first trimester of a pregnancy. Prozac may increase the risk of birth defects such as Persistent Pulmonary Hypertension (PPHN), as well as heart, lung, abdominal, cranial and/or facial defects, clubfoot and other birth defects. Taken by adults, Prozac can also cause significant weight gain. In children, adolescents and young adults, the drug has been shown to increase the risk of suicide or suicidal thoughts.
FDA Warnings for Prozac
The FDA issued a health advisory regarding Prozac in July 2006. The agency alert stated that Prozac can increase the risk of persistent pulmonary hypertension (PPHN), a serious, life-threatening lung condition that occurs soon after birth. In Dec. 2005, the agency issued a public health advisory regarding Prozac based upon two separate studies that linked SSRI’s (such as Prozac) with birth defects. The FDA has now moved Prozac to a category D drug, up from its previous category C classification, which means it has been shown to raise the risk of causing harm to a developing fetus.
Prozac has a black box warning which notes the drug increases risks of suicidal thinking and behavior in children, adolescents and young adults taking SSRIs or antidepressants for Major Depressive Disorder (MDD) and other psychiatric disorders. The box also cautions against using Prozac and olonzapine in combination.
Prozac Recall Information
Prozac remains on the market despite evidence to suggest it raises the risks of serious birth defects when taken by women during the first trimester of pregnancy. If Prozac is recalled, we will publish that information here on our web site, so please stay tuned.
What is Prozac?
Prozac is a medication used to treat depression and other anxiety disorders, including major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), social anxiety disorder and anxiety disorder.
- goes by the generic name fluoxetine™
- contains the active ingredient fluoxetine hydrochloride
- was originally marketed in 1986
- is manufactured by Ely Lilly and Company
- has not been approved by the FDA for anyone under 18 years of age
- has been approved for Major Depressive Disorder (MDD), Obsessive Compulsive Disorder (OCD), Bulimia Nervosa, Panic Disorder, Depressive episodes associated with bipolar disorder, Treatment-resistant Depression.
Off –label Uses of Prozac
Despite severe side effects related to the use of Prozac, some users take the drug for —
- Premature ejaculation
- Chronic headache
- Bipolar disorder
- Irritable bowel syndrome
- Pathological gambling
- Diabetic neuropathy
Prozac Side Effects
While Prozac can be effective for its approved uses, side effects associated with the drug are often severe and potentially life threatening. They include:
- Birth Defects
- Congenital Heart Defects
- Persistent Pulmonary Hypertension of the Newborn (PPHN Depression)
- Cranial Birth Defects
- Cleft Palate/Hare Lip
- Weight gain
- suicide attempt(s)
- dangerous impulse acting
- aggression or violence
- suicidal thoughts
- new or worsening depression
- new or worsening anxiety or panic attacks
- agitation, restlessness, anger, irritability
- sleep deprivation
- abnormal activity increase(s) or excessive talking
- Other unusual changes in mood or behavior
- See other Prozac side effects here
FDA Alerts for Prozac
The FDA in July 2006 issued two alerts regarding Prozac . The first concerned a study showing that women who took SSRIs while pregnant stood a greater chance of giving birth to babies with Persistent Pulmonary Hypertension (PPHN). The second warned that Serotonin Syndrome, a life-threatening condition, can occur when SSRIs (such as Prozac) are taken simultaneously with meds used for the treatment of migraines known as 5-hydrosytryptamine receptor agonists (triptans). The FDA has also worked with Pfizer, the makers of Prozac to better assess the dangers of suicidal thoughts in children and adolescents taking Prozac. A black box warning has been added to Prozac to warn of suicidal thoughts that may occur with ingestion of the drug.
Prozac creator Ely Lilly’s literature regarding the drug included the language: “Prozac and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.