A black box warning predicating about increased risk of suicide in persons younger than 25 is required by FDA for all antidepressant medicications. Dualfold growth of the suicidal ideation and behavior in children and adolescents was observed by two independent groups of the FDA experts. 1.5-fold augmentation of suicidality was reported in the age group of 18–24 years old.

It was observed that suicide addiction in patients olden than 24 had been declined in a minor way while it had decreased in a great measure in group in the age of 65 and older. Donald Klein criticized that analysis. He suggested that suicidality (that is defined as suicidal ideation and behavior) should not be undoubtedly a good surrogate marker for completed suicide. He also supposed that antidepressant medications increasing suicidality might avert actual event of suicide. That supposal runs counter to current beliefs in which suicidal ideation has been in one-to-one correspondence with attempt of suicide in retrospective studies and with suicide in prospective studies.

Suicidality and Prozac

It is hard enough to study suicidal ideation and behavior in clinical trials due to their infrequency. The results of 295 trials of 11 antidepressants for psychiatric indications should be united by FDA experts in order to obtain statistically significant data and analyze them. Probability value of suicidality in children using Prozac amplifies in half as large again (those data are not statistically significant in view of paucity of cases). While it was reported about reduction of probability value of suicidality in adult patients taking Prozac around at one third (those data are statistically significant).

The UK Medicines and Healthcare products Regulatory Agency (MHRA) pursue similiar investigation. The experts of UK MHRA reported about1.5-fold augmentation of probability value of suicide-related events in the children and adolescents on Prozac therapy as opposed to placebo group. Those data also didn’t reach statistical significance. They assert that the rate of self-harm for adults taking Prozac is similar to placebo group while suicidal ideation decreased twice (statistically significantly data)

Nausea (22% vs 9% for placebo), insomnia (19% vs 10% for placebo), somnolence (12% vs 5% for placebo), anorexia (10% vs 3% for placebo), anxiety (12% vs 6% for placebo), nervousness (13% vs 8% for placebo), asthenia (11% vs 6% for placebo) and tremor (9% vs 2% for placebo)are the common adverse effects caused with Prozac and greatly differing from placebo therapy.

7% of patients taking Prozac in clinical trials reported about rash or urticaria, sometimes serious. Discontinuation of the Prozac therapy leaded to that side effect in 32% of those patients. There are some reports about several cases of complications developed in patients with rash. Vasculitis and lupus-like syndrome were observed in those cases. Those systemic events gave occasion to death.

Akathisia is a common side effect of Prozac . It is often accompanied by purposeless movements of the feet and legs, constant pacing, and marked anxiety. Akathisia usually appears after the beginning of the Prozac therapy or increase of the dose. Reducing of Prozac dose, discontinuation of drug or treatment with propranolol can remove or relieve akathisia symptoms. There are proves that akathisia and suicidal attempts are relative. It was reported that there were patients who had been feeling better after the withdrawal of Prozac , but relapsed severe akathisia symptoms after resumption of Prozac therapy. The development of the akathisia forced those patients to wish to make quietus and that it had brought back about their prior suicide attempts. Physician should describe symptoms of akathisia to patients and staff because of coupling of akathisia with suicide and the distress. More rarely, Prozac can cause side effects related with movement disorders such as acute dystonia and tardive dyskinesia.

Increase of rate of poor adaptation of newborns can be resulted with taking Prozac during pregnancy. Mothers having Prozac therapy shouldn’t breastfeed because Prozac was found in milk. Prozac is classified by the American Association of Pediatrics as a drug for which the effect on the breastfeeding baby is still unknown but may be of great importance.

FDA has approved Prozac as the treatment of major depression (MDD), obsessive compulsive disorder (OCD), bulimia nervosa and panic disorder. Prozac proved its efficacy for depression in 6-week long double-blind controlled trials where it also relieved anxiety and improved sleep. Prozac was more effective against placebo for the prevention of depression relapse when the patients, who originally responded to Prozac, were treated for a further 38 weeks. It was found out in placebo-controlled trials that Prozac therapy is effective both in geriatric and pediatric depression.

Physicians can prescribe Prozac for treatment OCD both in adults and children. As against to depression treatment higher doses of Prozac have been more effective in treatment of Obsessive–compulsive disorder. Prozac approved itself as perfect drug in treatment of patients suffering from panic disorder. Using Prozac therapy in such patients leads to exceeding reduction of frequency of panic attacks. Quantity of binge-eating and purging episodes of bulimia nervosa can be significantly decreased if Prosac is taken. It was proved that using placebo for the prevention of bulimia nervosa is not nearly as good as long-termed (year-long) Prozac treatment.