This table shows all Adverse Drug Reactions reported to the FDA's Adverse Event Reporting System between 2004 and the 2nd Quarter of 2008 where the listed psychiatric drug was identified as the Primary Suspect Drug (FDA's term) deemed responsible for causing or inducing these reactions and where one or more of the Adverse Reactions reported for the Case described a congenital, prenatal or neonatal condition. Where no Age, Date of Event or Indication (the condition being treated) are shown, none were present in the FDA records.

Reported By: CN-Consumer, LW-Lawyer, MD-Physician, OT-Other Healthcare Provider, PH-Pharmacist, Blank-Not Reported in ISR (Individual Safety Report).

The Oxford English Dictionary defines a poison as "a substance that causes death or harm when introduced into or absorbed by a living organism."  This psychiatric drug fits that definition.

Fluctin (fluoxetine), Fluctine (fluoxetine), Fluoxetine (fluoxetine), Fontex (fluoxetine), Lovan (fluoxetine), Prozac (fluoxetine), Sarafem (fluoxetine), Zactin (fluoxetine)

Abdominal Pain, Abdominal Pain Upper, Abnormal Behaviour, Abortion Induced, Abortion Late, Abortion Spontaneous, Abscess, Acidosis, Adrenogenital Syndrome, Adverse Event, Aggression, Agitation, Agitation Neonatal, Alanine Aminotransferase Increased, Amenorrhoea, Amimia, Amniocentesis Abnormal, Anaemia, Anal Atresia, Anencephaly, Anger, Ankyloglossia Congenital, Anomalous Pulmonary Venous Connection, Anorectal Agenesis, Anotia, Anterior Chamber Cleavage Syndrome, Antidepressant Drug Level Increased, Anxiety, Aorta Hypoplasia, Apgar Score Low, Apnoea, Arrested Labour, Arthralgia, Aspartate Aminotransferase Increased, Assisted Delivery, Asthenia, Atrial Septal Defect, Atrioventricular Septal Defect, Autism, Base Excess Increased, Bipolar I Disorder, Blood Bilirubin Increased, Blood Culture Positive, Blood Electrolytes Decreased, Blood Gases Abnormal, Blood Glucose Abnormal, Blood Glucose Decreased, Blood Lactic Acid Increased, Blood PH Decreased, Blood Pressure Increased, Blood Prolactin Increased, Blood Sodium Decreased, Body Temperature Decreased, Body Temperature Fluctuation, Body Temperature Increased, Bowel Movement Irregularity, Bradycardia Foetal, Bradycardia Neonatal, Brain Oedema, Branchial Cleft Cyst, Branchial Cleft Sinus, Breast Enlargement, Breech Presentation, Brief Psychotic Disorder With Postpartum Onset, Caesarean Section, Cardiac Disorder, Cardiac Flutter, Cardiac Murmur, Cardiopulmonary Failure, Cerebral Haematoma, Cerebral Haemorrhage Neonatal, Cerebral Thrombosis, Cerebral Ventricle Dilatation, Cervix Cerclage Procedure, Chills, Cholestasis, Chronic Respiratory Disease, Clavicle Fracture, Cleft Lip, Cleft Palate, Cleft Uvula, Clonus, Coarctation of the Aorta, Cognitive Disorder, Coma, Coma Neonatal, Completed Suicide, Complex Partial Seizures, Complication of Pregnancy, Complications of Maternal Exposure To Therapeutic Drugs, Concomitant Disease Progression, Condition Aggravated, Congenital Absence of Bile Ducts, Congenital Anomaly, Congenital Atrial Septal Defect, Congenital Bladder Anomaly, Congenital Brain Damage, Congenital Cardiovascular Anomaly, Congenital Cystic Kidney Disease, Congenital Cystic Lung, Congenital Eye Disorder, Congenital Floppy Infant, Congenital Foot Malformation, Congenital Hand Malformation, Congenital Hepatobiliary Anomaly, Congenital Hydronephrosis, Congenital Multiplex Arthrogryposis, Congenital Neurological Disorder, Congenital Pulmonary Hypertension, Congenital Pulmonary Valve Atresia, Congenital Pulmonary Valve Disorder, Congenital Renal Disorder, Congenital Scoliosis, Congenital Spinal Cord Anomaly, Congenital Tracheomalacia, Congenital Tricuspid Valve Atresia, Congenital Ventricular Septal Defect, Constipation, Contraceptive Device Complication, Convulsion, Convulsion Neonatal, Corynebacterium Infection, Crying, Cyanosis, Cyanosis Central, Cyanosis Neonatal, Cytolytic Hepatitis, Dacryostenosis Acquired, Dandy-Walker Syndrome, Deafness, Deafness Congenital, Deafness Neurosensory, Deafness Unilateral, Death Neonatal, Deformity Thorax, Dehydration, Delusion of Grandeur, Dental Caries, Depression, Developmental Delay, Diabetes Mellitus Insulin-Dependent, Diarrhoea, Diarrhoea Neonatal, Difficulty In Walking, Disease Progression, Dizziness, Double Ureter, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Drug Interaction, Drug Level Increased, Drug Toxicity, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Dry Mouth, Dyskinesia, Dyskinesia Neonatal, Dyslexia, Dysmorphism, Dysphagia, Dyspnoea, Ectopic Pregnancy, Electrocardiogram QT Corrected Interval Prolonged, Electrocardiogram QT Prolonged, Electroencephalogram Abnormal, Emotional Distress, Enamel Anomaly, Encephalitis, Encephalopathy Neonatal, Escherichia Urinary Tract Infection, Expressive Language Disorder, Extrapyramidal Disorder, Eye Disorder, Eye Movement Disorder, Facial Dysmorphism, Facial Palsy, Fallot's Tetralogy, Fatigue, Fear, Feeding Disorder Neonatal, Feeding Disorder of Infancy or Early Childhood, Feeding Problem In Child, Feeding Problem In Newborn, Feeling Abnormal, Feeling Jittery, Fever Neonatal, Fistula, Flatulence, Floppy Infant, Flushing, Foetal Arrhythmia, Foetal Cystic Hygroma, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Heart Rate Abnormal, Foetal Heart Rate Deceleration, Foetal Heart Rate Decreased, Foetal Heart Rate Disorder, Forceps Delivery, Gamma-Glutamyltransferase Increased, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Gastroschisis, Gestational Diabetes, Grand Mal Convulsion, Grimacing, Grunting, Haemangioma Congenital, Haematochezia, Haematoma, Haemoglobin Decreased, Haemorrhage, Hallucination, Hallucinations (Mixed), Hand Deformity, Headache, Heart Disease Congenital, Heart Rate Increased, Heart Rate Irregular, Hellp Syndrome, Hepatic Enzyme Increased, High Arched Palate, Hip Dysplasia, Hyperbilirubinaemia Neonatal, Hyperglycaemia, Hyperhidrosis, Hyperinsulinism, Hyperreflexia, Hypertelorism of Orbit, Hypertension, Hypertension Neonatal, Hyperthermia, Hypertonia, Hypertonia Neonatal, Hypervigilance, Hypoacusis, Hypocalcaemia, Hypoglycaemia, Hypoglycaemia Neonatal, Hypokinesia Neonatal, Hypoplastic Left Heart Syndrome, Hypoplastic Right Heart Syndrome, Hypospadias, Hypothermia, Hypothermia Neonatal, Hypotonia, Hypotonia Neonatal, Hypoventilation, Hypoventilation Neonatal, Iiird Nerve Paralysis, Ill-Defined Disorder, Impaired Driving Ability, Induced Labour, Infantile Apnoeic Attack, Infantile Colic, Infantile Spitting Up, Infected Cyst, Insomnia, Intentional Overdose, Intra-Uterine Death, Intraventricular Haemorrhage, Intraventricular Haemorrhage Neonatal, Irritability, Jaundice, Jaundice Neonatal, Labour Complication, Labour Induction, Lacrimation Increased, Large for Dates Baby, Laryngomalacia, Learning Disability, Lethargy, Limb Hypoplasia Congenital, Limb Reduction Defect, Liver Function Test Abnormal, Liver Transplant, Loose Stools, Loss of Consciousness, Loss of Employment, Lyme Disease, Malaise, Malnutrition, Mania, Mastectomy, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Measles Antibody Positive, Meconium In Amniotic Fluid, Medication Error, Melaena, Meningitis Chemical, Meningitis Neonatal, Metabolic Acidosis, Metrorrhagia, Microcephaly, Micrognathia, Microtia, Migraine, Moaning, Mobility Decreased, Moebius II Syndrome, Movement Disorder, Multiple Cardiac Defects, Multiple Congenital Abnormalities, Myalgia, Myoclonic Epilepsy, Myoclonus, Nausea, Neck Deformity, Neonatal Apnoeic Attack, Neonatal Asphyxia, Neonatal Aspiration, Neonatal Diabetes Mellitus, Neonatal Disorder, Neonatal Hypotension, Neonatal Infection, Neonatal Respiratory Acidosis, Neonatal Respiratory Arrest, Neonatal Respiratory Depression, Neonatal Respiratory Distress Syndrome, Neonatal Tachycardia, Neonatal Tachypnoea, Nerve Injury, Nervous System Disorder, Nervousness, Neural Tube Defect, Nightmare, Oedema Neonatal, Oesophageal Atresia, Oligohydramnios, Opisthotonus, Overdose, Oxygen Saturation Decreased, Pallor, Paraesthesia, Paranoia, Patent Ductus Arteriosus, PCO2 Decreased, PCO2 Increased, Persistent Foetal Circulation, Petechiae, Phalangeal Agenesis, Pharmaceutical Product Complaint, Phobia, Pierre Robin Syndrome, Placenta Praevia, Placenta Praevia Haemorrhage, Placental Disorder, Placental Insufficiency, Platelet Count Decreased, PO2 Decreased, Polyhydramnios, Poor Sucking Reflex, Poor Weight Gain Neonatal, Post Procedural Complication, Postpartum Depression, Postpartum Disorder, Pre-Eclampsia, Premature Baby, Premature Closure of Cranial Sutures, Premature Labour, Premature Rupture of Membranes, Premature Separation of Placenta, Pressure of Speech, Protein Urine Present, Pruritus, Psychomotor Hyperactivity, Psychomotor Retardation, Psychomotor Skills Impaired, Pulmonary Artery Atresia, Pulmonary Artery Stenosis Congenital, Pulmonary Congestion, Pulmonary Haemorrhage, Pulmonary Hypertension, Pulmonary Hypoplasia, Pulmonary Malformation, Pulmonary Oedema, Pulmonary Oedema Neonatal, Pulmonary Valve Stenosis, Pulmonary Valve Stenosis Congenital, Pulmonary Vascular Disorder, Pyrexia, Rash, Rash Neonatal, Rash Pustular, Rectal Haemorrhage, Red Blood Cell Sedimentation Rate Increased, Reflexes Abnormal, Respiratory Arrest, Respiratory Disorder, Respiratory Disorder Neonatal, Respiratory Distress, Respiratory Rate Increased, Respiratory Syncytial Virus Infection, Respiratory Tract Haemorrhage Neonatal, Restlessness, Retching, Retrognathia, Salivary Hypersecretion, Scratch, Sepsis, Sepsis Neonatal, Serotonin Syndrome, Single Umbilical Artery, Skull Malformation, Sleep Apnoea Syndrome, Sleep Disorder, Small for Dates Baby, Sneezing, Somnolence, Somnolence Neonatal, Speech Disorder, Spina Bifida, Staphylococcal Infection, Stillbirth, Strabismus, Streptococcal Infection, Stress, Subdural Haemorrhage Neonatal, Suicidal Ideation, Syndactyly, Systemic Lupus Erythematosus, Tachycardia, Tachypnoea, Talipes, Tardive Dyskinesia, Temperature Regulation Disorder, Thalamus Haemorrhage, Therapy Cessation, Threatened Labour, Thrombocytopenia, Thymus Hypoplasia, Thyroiditis, Toe Deformity, Tongue Disorder, Tooth Discolouration, Tooth Loss, Toothache, Tracheo-Oesophageal Fistula, Transient Tachypnoea of the Newborn, Transposition of the Great Vessels, Treatment Noncompliance, Tremor, Tremor Neonatal, Tricuspid Valve Incompetence, Trisomy 21, Ultrasound Doppler Abnormal, Umbilical Cord Abnormality, Umbilical Cord Around Neck, Umbilical Cord Compression, Unequal Limb Length, Unevaluable Event, Unresponsive To Pain Stimuli, Unwanted Pregnancy, Urinary Tract Infection, Urinary Tract Infection Neonatal, Urinary Tract Obstruction, Uterine Hypertonus, Vacuum Extractor Delivery, Vaginal Haemorrhage, Vaginal Infection, Ventricular Fibrillation, Ventricular Hypoplasia, Ventricular Septal Defect, Visual Disturbance, Vomiting, Vomiting Neonatal, Weight Decreased, Weight Gain Poor, Weight Loss Poor, Withdrawal Syndrome, Wound Infection Staphylococcal, Wrong Drug Administered, XYY Syndrome, Yawning

Definitions
Abortion Spontaneous	Miscarriage means loss of an embryo or fetus before the 20th week of pregnancy. Most miscarriages occur during the first 14 weeks of pregnancy. The medical term for miscarriage is spontaneous abortion.
Anencephaly	Congenital absence of most of the brain and spinal cord.
Ankyloglossia	A congenital anomaly in which the mucous membrane under the tongue is too short limiting the mobility of the tongue.
Anotia	Congenital absence of one or both ears.
Aorta Hypoplasia	[Aorta] The main trunk of the systemic arteries, carrying blood from the left side of the heart to the arteries of all limbs and organs except the lungs. [Hypoplasia] Incomplete or arrested development of an organ or a part.
Atrial Septal Defect	An atrial septal defect is an abnormal opening in the wall separating the left and right upper changers (atria) of the heart.
Coloboma	An anomaly of the eye, usually a developmental defect, that often results in some loss of vision.
Congenital	A physical abnormality that is present at birth.
Congenital Atrial Septal Defect	An abnormal opening in the wall separating the left and right upper chambers (atria) of the heart.
Congenital Multiplex Arthrogryposis	A rare disorder (9 reported Cases here) that is present at birth, is characterized by reduced mobility of many joints of the body. Impairment of mobility is due to the overgrowth (proliferation) of fibrous tissue in the joints (fibrous ankylosis - a stiffening of a joint due to the presence of fibrous bands between and about the bones forming the joint). In the most common form, the range of motion of the joints in the arms and legs is limited or fixed. Other forms may include inward rotation of the shoulders, abnormal extension of the elbows, and bending of the wrists and fingers. In addition, the hips may be dislocated and the heels of the feet may be inwardly bent from the midline of the leg while the feet are inwardly bent at the ankle (clubfoot).
Dandy-Walker Syndrome	Dandy-Walker syndrome refers to a group of specific, congenital brain malformations, and is a common cause of hydrocephalus (increased fluid in the brain).
Drug Withdrawal Syndrome Neonatal	Refers to the characteristic signs and symptoms that appear when a drug that causes physical dependence is regularly used for a long time and then suddenly discontinued or decreased in dosage. Also known as abstinence syndrome. A group of unpleasant symptoms produced by the abrupt termination of drug taking. These symptoms, commonly called withdrawal symptoms, include anxiety, muscle weakness, nausea, vomiting, tremor, and a rapid heart beat.
Ectopic Pregnancy	In an ectopic pregnancy, the fertilized egg implants in a location outside the uterus and tries to develop there. The word ectopic means "in an abnormal place or position." The most common site is the fallopian tube, the tube that normally carries eggs from the ovary to the uterus. However, ectopic pregnancy can also occur in the ovary, the abdomen, and the cervical canal (the opening from the uterus to the vaginal canal). The phrases tubal pregnancy, ovarian pregnancy, cervical pregnancy, and abdominal pregnancy refer to the specific area of an ectopic pregnancy.
Fallot's Tetralogy	A congenital malformation of the heart characterized by a defect in the ventricular septum, misplacement of the origin of the aorta, narrowing of the pulmonary artery, and enlargement of the right ventricle.
Hypoplastic Left Heart Syndrome	(Also known as HLHS), is a rare congenital heart defect in which the left side of the heart is severely underdeveloped. In babies with HLHS, the aorta and left ventricle are very small, and the aortic and mitral valves are either too small to allow sufficient blood flow or are atretic (closed) altogether. As blood returns from the lungs to the left atrium, it must pass through an atrial septal defect to the right side of the heart. In a healthy human, the left side of the heart receives oxygen-rich blood from the lungs and pumps it out to the rest of the body; with these structures underdeveloped, they cannot circulate blood to other organs, and the right ventricle must pump blood to both the lungs, as it would normally, and to the rest of the body, a situation which cannot be sustained for long. In cases of HLHS, the right side of the heart often must pump blood to the body through a patent ductus arteriosus. As the ductus arteriosus closes a few days after birth, blood flow is severely restricted and eventually cut off, leading to dangerously low circulation and eventually to shock.
Neural Tube Defect	Any of various congenital defects of the brain and spinal cord, such as spina bifida, resulting from incomplete closing of the neural tube in an embryo.
Persistent Foetal Circulation	The circulation of blood in the foetus is somewhat different from that of the baby after birth. This transition from foetal to neonatal circulation is one of the major physiologic changes after delivery. Before birth, the lungs are collapsed and the blood pressure in the lungs is quite high. This results in a very low blood flow through the lungs. After delivery, the lungs expand and the blood pressure in the lungs decreases.
	In some babies, although the lungs expand the blood vessels in the lungs remain constricted resulting in persistently high blood pressure in the lungs. This reduces the amount of blood that the infant can pump through the lungs. This decreased blood flow through the lungs after birth is called persistent foetal circulation because it is a persistence of the pattern of blood flow normally seen prior to birth during the foetal period.
Pierre Robin Syndrome	Pierre Robin Syndrome (PRS) is a congenital condition of facial abnormalities in humans. As PRS is not caused by a single defect gene, it is not a genetic syndrome, but rather a chain of certain developmental malformations, one entailing the next. [images]
Pulmonary Hypertension	Pulmonary hypertension is a rare lung disorder characterized by increased pressure in the pulmonary artery. The pulmonary artery carries oxygen-poor blood from the lower chamber on the right side of the heart (right ventricle) to the lungs where it picks up oxygen. The disorder results in thickening of the pulmonary arteries and narrowing of these blood vessels. In response, the right side of the heart works harder to move the blood through these arteries and it becomes enlarged. Eventually overworking the right side of the heart which may lead to right-sided heart failure, resulting in death.
	According to this WebMD article: "Babies whose mothers took antidepressant drugs in the second half of pregnancy are six times more likely to have a rare but dangerous lung ailment, a new study suggests.
	"One study isn't proof. But it's strong evidence that taking SSRI antidepressants — such as Prozac, Zoloft, and Paxil — carries an extra risk during pregnancy.
	"The risk is that the babies will have PPHN: persistent pulmonary hypertension of the newborn. Only one or two in a thousand babies get this, but it's very serious. It kills about one in 10 babies who get it. In moderately severe cases, half the survivors suffer hearing loss or brain damage."
Spina Bifida	A serious birth abnormality in which the spinal cord is malformed and lacks its usual protective skeletal and soft tissue coverings.
	Spina bifida may appear in the body midline anywhere from the neck to the buttocks. In its most severe form, termed spinal rachischisis, the entire spinal canal is open, exposing the spinal cord and nerves. More commonly, the abnormality appears as a localized mass on the back that is covered by skin or by the meninges, the three-layered membrane that envelopes the spinal cord. Spina bifida is usually readily apparent at birth because of the malformation of the back and paralysis below the level of the abnormality.
Transposition of the Great Vessels	In transposition of the great arteries (vessels), the aorta and pulmonary artery are reversed. The aorta receives the oxygen-poor blood from the right ventricle, but it's carried back to the body without receiving more oxygen. Likewise, the pulmonary artery receives the oxygen-rich blood from the left ventricle but carries it back to the lungs. All patients with transposition of the great arteries require surgery early in life to survive. The surgical procedure enlarges a naturally occurring connection between the right and left upper chambers (the atria). This lets the blood mix so some oxygen-rich and oxygen-poor blood can be pumped to the correct side.
Trisomy 21	Down syndrome is the most common cause of mental retardation and malformation in a newborn. It occurs because of the presence of an extra chromosome. The extra chromosome in Down syndrome is labeled number 21. For this reason, the existence of three such chromosomes is sometimes referred to as Trisomy 21.
Ventricular Septal Defect	A ventricular septal defect is a hole in the wall of the heart (septum) that separates the left lower chamber (left ventricle) from the right lower chamber (right ventricle). The hole allows blood to flow from the left ventricle to the right ventricle instead of entering the aorta for distribution throughout the body. Ventricular septal defect is one of a group of heart problems found in newborn babies that are collectively called congenital heart disease.

MedWatch is the Food and Drug Administration's program for reporting any undesirable experience associated with the use of a medical product. If you think you or someone in your family has experienced an adverse reaction from taking Fluoxetine and it has not been reported to the FDA, see this page for instructions on reporting the adverse event through your doctor or directly to the FDA using an online form.

A May 2006 USA Today article states that "drug companies are required to file any reports they have to the FDA, but consumers and doctors report such events on a voluntary basis. Studies suggest the FDA's Adverse Events Reporting System database captures only 1% to 10% of drug-induced side effects and deaths, "maybe even less than 1%," says clinical pharmacologist Alastair J.J. Wood, an associate dean at Vanderbilt Medical School in Nashville. So the real number of cases is almost certainly much higher".