What is Prozac?

Prozac (fluoxetine hydrochloride) is used to treat depression, obsessive-compulsive disorder (OCD), bulimia nervosa, and panic disorder. Prozac is in a class of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). Prozac is made by Eli Lilly and Company and was approved by the U.S. Food and Drug Administration (FDA) in 1987.

Taking Prozac

Prozac is taken by mouth, with or without food, as prescribed by your healthcare professional. Take the weekly version of Prozac only once a week. Do not start taking the weekly version of Prozac until 7 days after you've taken the last dose of the daily Prozac.

Prozac FDA Alert - Serotonin Syndrome

In July 2006, the FDA issued an alert stating that a life-threatening condition called serotonin syndrome can occur when medicines called Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs, such as Prozac) and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are taken together. Signs and symptoms of serotonin syndrome include:

• restlessness
• hallucinations
• loss of coordination
• fast heartbeat
• increased body temperature
• fast changes in blood pressure
• overactive reflexes
• diarrhea
• coma
• nausea
• vomiting

Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SNRI or a triptan. If you take migraine headache medicines, ask your healthcare professional if your medicine is a triptan.

FDA Alert - Antidepressants and Pregnant Women

Also in July 2006, an FDA alert announced the results of a study looking at the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN).

Babies born with PPHN have abnormal blood flow through the heart and lungs, and do not get enough oxygen to their bodies. Babies with PPHN can be very sick, and may die. Results from the study also showed that babies born to mothers who took SSRIs 20 weeks or later into their pregnancies had a higher chance (were 6 times as likely) of developing PPHN than babies born to mothers who did not take antidepressants during pregnancy. The FDA has announced plans to further examine the role of SSRIs in babies with PPHN.

Talk to your doctor if you are taking Prozac and are pregnant or are planning to become pregnant. You and your healthcare professional can decide the best way to treat your depression during pregnancy.

More information on antidepressants is available from the FDA here.

Prozac and Increased Risk of Suicidality

In October 2004, the FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their product labeling to include boxed warning and expanded warning statements that alert healthcare providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these medications. Prozac maker Eli Lilly and Company has since added a black box warning to Prozac prescribing information in response to the FDA advisory. Click here for more information on this advisory.

In June 2005, the FDA announced that several recent scientific publications suggested the possibility of an increased risk for suicidal behavior in adults being treated with antidepressant medications, including Prozac. The FDA advised that adults taking antidepressants (particularly those being treated for depression) should be watched closely for worsening depression and increased suicidality. Monitoring these patients is especially important when treatment begins, and when doses are increased or decreased. The FDA is working closely with antidepressant manufacturers to fully evaluate the risk of suicidality in adults treated with these medications. Click here for more information on this advisory.

Who Should Not Take Prozac?

Never take Prozac if you are taking another drug used to treat depression called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking Prozac and an MAOI within a close period of time can result in serious (and sometimes fatal) reactions including:

• High body temperature
• Coma
• Seizures (convulsions)

Do not take an MAOI within 5 weeks of stopping Prozac. MAOI drugs include:

• Nardil (phenelzine sulfate)
• Parnate (tranylcypromine sulfate)
• Marplan (isocarboxazid)
• Other brands

Never take Prozac if you are taking Mellaril (thioridazine), a drug used to treat schizophrenia. Do not take Mellaril within 5 weeks of stopping Prozac. Taking Prozac and Mellaril within a close period of time can result in serious heartbeat problems.