What is Prozac?

Fluoxetine hydrochloride or Prozac belongs to a class of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). It is a prescription drug used for treatment of depression, panic disorder, bulimia nervosa and obsessive-compulsive disorder (OCD). Eli Lilly and Company is the maker of Prozac and the US Food and Drug Administration (FDA) approved it on 1987.

How is Prozac Taken

Prozac is taken orally either together with food or not, depending on how it is prescribed by the doctor. There is a weekly type of Prozac intended to be taken once within a week. It should not be taken within 7 days from the last intake of a daily Prozac.

Prozac FDA Alert – Serotonin Syndrome

The US FDA issued an alert in July 2006, warning of the possible development of a life-threatening condition called serotonin syndrome which may be caused by Serotonin and Norepinephrine Reuptake Inhibitors (SNRI) such as Prozac, if they are taken with migraine medications such as 5-hydroxytryptamine receptor agonists (triptans).

Signs and symptoms of serotonin syndrome include:

• Vomiting
• Nausea
• Diarrhea
• Fast heartbeat
• Restlessness
• Fast changes in blood pressure
• Hallucinations
• Loss of coordination
• Increased body temperature
• Overactive reflexes
• Coma

Serotonin syndrome is more likely to occur at the start or increase of the dose of an SNRI or a triptan. Make sure to inform your healthcare professional if you are taking triptan before taking Prozac.

FDA Alert – Antidepressants and Pregnant Women

In the same month as the alert for the serotonin syndrome, FDA issued another alert in response to a result of a study on the effects on their babies of the use of antidepressants by pregnant women. It has been found that such babies will most likely be born with a very serious condition persistent pulmonary hypertension of the newborn (PPHN).

PPHN is a very serious condition and may even cause deaths in infants afflicted with it because it causes an abnormal flow to the heart and lungs, resulting in an insufficient amount of oxygen supply in these organs. The FDA said they will conduct further studies to find out the effects of taking SSRIs while pregnant to the newborn babies.

If you are pregnant or have plans of conceiving, discuss it with your healthcare provider.

For more information on antidepressants, visit the FDA website by following this link.

Prozac and Increased Risk of Suicidality

The FDA issued an advisory in October 2004, directing all manufacturers of antidepressants to make changes on their products’ labels and include a 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. Eli Lilly complied with this and included a boxed warning indicating such on Prozac packaging.

Another announcement was made by the FDA in June 2005 to let the public know of what scientific publications have to say about the effects of antidepressants such as Prozac. These publications have suggested that there may be an increased risk of suicidal behavior in adults taking such medications. The FDA recommends that such individuals should be closely watched for signs of worsening of their depression and increase in suicidality, especially at the start of the medication, or when changes in the dosage is administered.

Who Should Not Take Prozac?

There are some people who are advised to not take Prozac, such as those who are already taking another medication for treatment of depression such as Monoamine Oxidase Inhibitor (MAOI), or if MAOI has been taken within the last 14 days prior.

Some examples of MAOI drugs are:

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

Prozac can react to MAOI and may sometimes cause:

• High body temperature
• Seizures (convulsions)
• Coma

Just the same, MAOI should not be taken within 5 weeks of taking Prozac.

Prozac should never be taken with the schizophrenia treatment called Mellaril (thioridazine). Mellaril should not be taken within 5 weeks of taking Prozac. These two drugs, when taken together within a close period may result in certain heart problems.

Health Risks of Prozac

Prozac may cause the following health risks:

• Weight loss
• Bleeding Problems
• Possible development of serotonin syndrome when Prozac is taken with triptan medicines
• Problems if you are or may become pregnant; babies delivered to mothers taking Prozac late in pregnancy have developed problems, such as difficulty breathing and feeding.
• Infant persistent pulmonary hypertension
• Sexual Problems, including impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire)
• Suicidal thoughts or actions
• Possible allergic reactions, such as skin rash, hives, breathing problems, or swelling of the tongue, lips, or throat
• Seizures (convulsions), even if not taken within a close period of time with a MAOI
• Mania (becoming unusually hyperactive, excitable, or elated)

Other side effects from Prozac use may include:

• Nausea
• Sleepiness
• Difficulty sleeping
• Anxiety
• Nervousness

There may also be some harmful side effects if Prozac is stopped suddenly. Your doctor should prescribe decreased dosage prior to weaning you off of Prozac.

Can Other Medicines or Food Affect Prozac?

Consult with your doctor if you are taking any other medicine, whether prescription or over-the-counter, vitamins or supplements, before taking Prozac. The following are some that may possibly cause unwanted health reactions when taken with Prozac:

• Those used to treat diabetes, seizures, mental illness, anxiety, or depression
• Those that affect bleeding
• Do not take Prozac with Sarafem (Prozac hydrochloride), a drug used to treat PreMenstrual Dysphoric Disorder (PMDD). These drugs are very similar and could result in an overdose.

Talk to your healthcare professional if you are on Prozac and you plan to take alcohol.

Get Legal Help

Even if most medicines are expected to have side effects, it is the duty of the manufacturer of these medicines to inform the medical community and the public of known risks associated with the drugs they produce. Failure to give adequate warning to the public and the medical community of the dangers of the drug makes the manufacturer liable under product liability for any injury that may be caused by their product.

If you or your loved one has suffered any of the dangerous symptoms or unusual reaction after taking Prozac, go to your doctor or the hospital as soon as possible. You may also consider consulting with an experienced attorney in order to get more information regarding your rights and possible remedies for the injuries you suffered because of the use of Prozac.