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.
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 4136947 | 4350881 | 04/27/2004 | Ziprasidone | MD | Schizophrenia | Complications of Maternal Exposure To Therapeutic Drugs, Eclampsia | |||||||
| F | 4136947 | 4390029 | 01/01/2004 | 06/30/2004 | Geodon | MD | Schizophrenia | Complications of Maternal Exposure To Therapeutic Drugs, Eclampsia, Infection, Postpartum Disorder | ||||||
| F | 4140121 | 4355498 | 05/04/2004 | Ziprasidone | MD | Ill-Defined Disorder | Complications of Maternal Exposure To Therapeutic Drugs, Intra-Uterine Death, Maternal Drugs Affecting Foetus | |||||||
| F | 4140121 | 4378928 | 06/10/2004 | Ziprasidone | MD | Ill-Defined Disorder | Drug Exposure During Pregnancy, Intra-Uterine Death | |||||||
| F | 5740984 | 4575873 | 02/04/2005 | Zeldox | MD | Schizophrenia | Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy | |||||||
| 5821185 | 4686567 | 06/06/2005 | Ziprasidone | OT | Bradyarrhythmia, Clinodactyly, Congenital Nail Disorder, Congenital Nose Malformation, Drug Exposure During Pregnancy, Electrocardiogram QT Prolonged, Facial Dysmorphism, Finger Hypoplasia, Foetal Arrhythmia, Foetal Growth Retardation, Foetal Malformation, Neonatal Hypoxia, Phalangeal Hypoplasia, Premature Baby, Reperfusion Injury, Small for Dates Baby, Toe Deformity | |||||||||
| F | 5960866 | 4875050 | 12/19/2005 | 01/04/2006 | Zeldox | CN | Psychotic Disorder | Abortion Spontaneous, Drug Exposure Before Pregnancy, Hormone Level Abnormal | ||||||
| F | 6039044 | 4983534 | 04/19/2006 | Zeldox | MD | Ill-Defined Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| M | 6128245 | 5097636 | 09/01/2006 | Zeldox | MD | Drug Exposure During Pregnancy, Neonatal Infection | ||||||||
| F | 6184843 | 5163529 | 11/24/2006 | Ziprasidone | Bipolar Disorder | Anxiety, Arrhythmia, Confusional State, Delirium, Disorientation, Drug Exposure During Pregnancy, Hallucination (Auditory), Infection, Insomnia, Mania, Neuroleptic Malignant Syndrome, Pharyngolaryngeal Pain, Pneumonia, Pulmonary Embolism, Respiratory Failure, Stress, Thrombosis, Urinary Bladder Haemorrhage | ||||||||
| 6211225 | 5202652 | 09/01/2006 | 01/09/2007 | Geodon | CN | Schizoaffective Disorder | Drug Exposure During Pregnancy, Trisomy 21 | |||||||
| 6220186 | 5215117 | 01/22/2007 | Geodon | MD | Congenital Anomaly, Drug Exposure During Pregnancy, Spina Bifida | |||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6224203 | 5147573 | 01/01/2006 | 11/06/2006 | Geodon | MD | Drug Exposure During Pregnancy, Foetal Growth Retardation | ||||||||
| 6224203 | 5188354 | 08/01/2006 | 12/14/2006 | Geodon | MD | Bipolar Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy, Small for Dates Baby | |||||||
| 6224203 | 5221279 | 08/01/2006 | 01/26/2007 | Geodon | MD | Bipolar Disorder | Drug Exposure During Pregnancy, Small for Dates Baby | |||||||
| M | 6280059 | 5287066 | 01/01/2006 | 04/04/2007 | Zeldox | MD | Drug Exposure During Pregnancy, Kidney Enlargement | |||||||
| M | 6280059 | 5320586 | 01/01/2006 | 05/09/2007 | Ziprasidone | MD | Drug Exposure During Pregnancy, Kidney Enlargement | |||||||
| F | 6567305 | 5645971 | 01/13/2008 | 02/29/2008 | Zeldox | MD | Abortion Spontaneous | |||||||
| M | 6614319 | 5704737 | 01/01/2007 | 04/14/2008 | Geodon | CN | Autism, Drug Exposure During Pregnancy | |||||||
| F | 6624997 | 5718522 | 04/25/2008 | Zeldox | MD | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||||
| M | 6625210 | 5718878 | 01/01/2008 | 04/25/2008 | Geodon | MD | Drug Exposure During Pregnancy, Pulmonary Hypertension | |||||||
| M | 6629903 | 5724385 | 04/30/2008 | Geodon | PH | Drug Exposure During Pregnancy, Pulmonary Hypertension | ||||||||
| 6679378 | 5786281 | 06/24/2008 | Zeldox | Adrenogenital Syndrome, Drug Exposure During Pregnancy | ||||||||||
| 6679705 | 5786625 | 06/24/2008 | Zeldox | Congenital Anomaly, Drug Exposure During Pregnancy | ||||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 16 | Years | F | 6208782 | 5188739 | 01/01/2006 | 12/15/2006 | Ziprasidone | MD | Bipolar Disorder | Abortion Spontaneous, Drug Exposure During Pregnancy, Extrapyramidal Disorder, Feeling Jittery, Retained Products of Conception, Sedation | ||||
| 22 | Years | F | 6140242 | 5113588 | 05/23/2006 | 09/21/2006 | Ziprasidone | PH | Schizophrenia | Drug Exposure During Pregnancy, Drug Toxicity, Electrocardiogram QT Corrected Interval Prolonged, Incorrect Dose Administered, Tachycardia | ||||
| 29 | Years | F | 6032999 | 4976069 | 03/23/2006 | 04/11/2006 | Geodon | MD | Bipolar Disorder | Caesarean Section, Drug Exposure During Pregnancy | ||||
| 29 | Years | F | 6032999 | 5004104 | 03/23/2006 | 05/11/2006 | Geodon | MD | Bipolar Disorder | Caesarean Section, Drug Exposure During Pregnancy | ||||
| 31 | Years | F | 6476403 | 5528192 | 10/08/2007 | 11/28/2007 | Zeldox | MD | Schizophrenia, Paranoid Type | Abortion Spontaneous | ||||
| 32 | Years | F | 5924377 | 4824362 | 04/01/2005 | 11/08/2005 | Geodon | MD | Ill-Defined Disorder | Abortion Spontaneous, Anxiety, Drug Dependence, Drug Exposure During Pregnancy, Insomnia, Pregnancy On Oral Contraceptive | ||||
| 33 | Years | F | 5960866 | 4911987 | 12/19/2005 | 02/13/2006 | Zeldox | MD | Psychotic Disorder | Abortion Spontaneous, Blood Human Chorionic Gonadotropin Decreased, Drug Exposure During Pregnancy | ||||
| 38 | Years | F | 5782883 | 4639088 | 03/04/2005 | 04/18/2005 | 03/04/2005 | Geodon | Completed Suicide, Drug Exposure During Pregnancy | |||||
| 38 | Years | F | 5782883 | 4645549 | 01/01/2004 | 04/25/2005 | 03/04/2005 | Geodon | Abnormal Behaviour, Completed Suicide, Depression, Drug Exposure During Pregnancy, Irritability | |||||
| 38 | Years | F | 5918540 | 4811818 | 10/26/2005 | Zeldox | MD | Schizophrenia | Caesarean Section, Drug Exposure During Pregnancy, Dyskinesia, Sleep Disorder | |||||
| 5 Males | 15 Females | 26 Cases (Gender was not reported for 6 Cases) | 34 Individual Safety Reports | |||||||||||
Geodon (ziprasidone), Zeldox (ziprasidone), Ziprasidone (ziprasidone)
Abnormal Behaviour, Abortion Spontaneous, Adrenogenital Syndrome, Anxiety, Arrhythmia, Autism, Blood Human Chorionic Gonadotropin Decreased, Bradyarrhythmia, Breech Presentation, Caesarean Section, Clinodactyly, Completed Suicide, Complications of Maternal Exposure To Therapeutic Drugs, Confusional State, Congenital Anomaly, Congenital Nail Disorder, Congenital Nose Malformation, Delirium, Depression, Disorientation, Drug Dependence, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Toxicity, Dyskinesia, Eclampsia, Electrocardiogram QT Corrected Interval Prolonged, Electrocardiogram QT Prolonged, Extrapyramidal Disorder, Facial Dysmorphism, Feeling Jittery, Finger Hypoplasia, Foetal Arrhythmia, Foetal Growth Retardation, Foetal Malformation, Hallucination (Auditory), Hormone Level Abnormal, Incorrect Dose Administered, Infection, Insomnia, Intra-Uterine Death, Irritability, Kidney Enlargement, Mania, Maternal Drugs Affecting Foetus, Neonatal Hypoxia, Neonatal Infection, Neuroleptic Malignant Syndrome, Phalangeal Hypoplasia, Pharyngolaryngeal Pain, Pneumonia, Postpartum Disorder, Pregnancy On Oral Contraceptive, Premature Baby, Pulmonary Embolism, Pulmonary Hypertension, Reperfusion Injury, Respiratory Failure, Retained Products of Conception, Sedation, Sleep Disorder, Small for Dates Baby, Spina Bifida, Stress, Tachycardia, Thrombosis, Toe Deformity, Trisomy 21, Urinary Bladder Haemorrhage
| Ziprasidone Adverse Reaction 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. |
| Blood Human Chorionic Gonadotropin Decreased | A hormone produced by the placenta that maintains the corpus luteum during pregnancy. (The corpus luteum (Latin for "yellow body") is a temporary endocrine structure in mammals, involved in the production of the progestogens which are needed for the maintenance of a pregnancy.) |
| Bradyarrhythmia | A disturbance of the heart's rhythm resulting in a rate under 60 beats per minute. |
| Clinodactyly | A medical term describing a bend or curvature of the fifth fingers (the "little fingers") toward the adjacent fourth fingers. [Images] |
| Congenital | A physical abnormality that is present at birth. |
| Congenital Anomaly | Medical term for a birth defect which is a physical abnormality that is present at birth; they are also called congenital abnormalities. When multiple birth defects occur together and have a similar cause, they are called syndromes (e.g. Neuroleptic Malignant Syndrome). |
| Dyskinesia | An impairment in the ability to control movements, characterized by spasmodic or repetitive motions or lack of coordination. |
| Extrapyramidal Disorder | Defects in basal ganglia function (the basal ganglia is a group of structures in the base of the brain involved in coordination and movement); characterized by changes in muscle tone, akinesia (loss or impariment of the power of voluntary movement), or dyskinesia (abnormal involuntary movements). |
| Facial Dysmorphism | An anatomical malformation of the face. [Images] |
| Finger Hypoplasia | Hypoplasia is the incomplete or arrested development of an organ or a part. |
| Neonatal Hypoxia | Deficiency in the amount of oxygen reaching body tissues. |
| Neuroleptic Malignant Syndrome | Neuroleptic malignant syndrome is a rare, potentially life-threatening disorder that is usually precipitated by the use of medications that block the neurotransmitter called dopamine. Most often, the drugs involved are those that treat psychosis, called neuroleptic medications. The syndrome results in dysfunction of the autonomic nervous system, the branch of the nervous system responsible for regulating such involuntary actions as heart rate, blood pressure, digestion, and sweating. Muscle tone, body temperature, and consciousness are also severely affected. |
| Phalangeal Hypoplasia | Phalangeal is the medical term for a bone of a finger or toe. See Finger Hyoplasia. |
| Pulmonary Hypertension | Pulmonary hypertension is a rare lung disorder characterized by increased pressure in the pulmonary artery. 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 may lead to right-sided heart failure, resulting in death. From 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." | |
| Reperfusion Injury | Reperfusion injury refers to damage to tissue caused when blood supply returns to the tissue after a period of ischemia (an insufficient supply of blood to an organ, usually due to a blocked artery). |
| 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. |
| 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. [Images] | |
| 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. [Images] |
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 Ziprasidone 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".