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. Healthcare Provider, PH-Pharmacist, Blank-Not Reported in ISR (Individual Safety Report)

Ativan (lorazepam), Lorax (lorazepam), Lorazepam (lorazepam), Orfidal (lorazepam), Tavor (lorazepam), Temesta (lorazepam)

Abortion Induced, Abortion Spontaneous, Accidental Exposure, Agitation, Agitation Neonatal, Amniotic Fluid Volume Decreased, Anorectal Disorder, Anxiety, Apgar Score Low, Aspiration, Atrial Septal Defect, Bradycardia Neonatal, Brow Presentation, Caesarean Section, Cervical Incompetence, Cleft Lip and Palate, Completed Suicide, Complications of Maternal Exposure To Therapeutic Drugs, Congenital Anomaly, Congenital Arterial Malformation, Congenital Cystic Kidney Disease, Congenital Ectopic Bladder, Congenital Ventricular Septal Defect, Convulsion, Convulsion Neonatal, Craniosynostosis, Cyanosis Neonatal, Diarrhoea Neonatal, Drug Effect Decreased, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Hypersensitivity, Drug Ineffective, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Electroconvulsive Therapy, Electroencephalogram Abnormal, Emotional Disorder, Encopresis, Enuresis, Fallot's Tetralogy, Fatigue, Feeding Disorder Neonatal, Feeding Problem In Newborn, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Gastrointestinal Malformation, Gastrooesophageal Reflux Disease, Haematoma, Heart Disease Congenital, Hernia Congenital, Hyperaesthesia, Hyperphagia, Hypersensitivity, Hypersomnia, Hypertonia, Hypertonia Neonatal, Hypokinesia Neonatal, Hypopnoea, Hyporeflexia, Hypospadias, Hypotonia Neonatal, Induced Labour, Infantile Apnoeic Attack, Infection, Insomnia, Intentional Overdose, Intercostal Retraction, Intestinal Perforation, Intra-Uterine Death, Irritability, Joint Hyperextension, Laboratory Test Abnormal, Laryngeal Disorder, Laryngomalacia, Maternal Drugs Affecting Foetus, Maternal Use of Illicit Drugs, Meconium In Amniotic Fluid, Meningomyelocele, Metabolic Disorder, Microcephaly, Monocytosis, Muscle Rigidity, Muscle Spasms, Nasal Flaring, Neonatal Apnoeic Attack, Neonatal Disorder, Neonatal Infection, Neonatal Respiratory Acidosis, Neonatal Respiratory Distress Syndrome, Neonatal Respiratory Failure, Neonatal Tachypnoea, Nervous System Disorder, No Therapeutic Response, Oesophagitis, Oligohydramnios, Overdose, Photophobia, Placental Insufficiency, Polyhydramnios, Poor Sucking Reflex, Potter's Syndrome, Pregnancy On Oral Contraceptive, Premature Baby, Premature Labour, Premature Rupture of Membranes, Prolonged Pregnancy, Pulmonary Hypoplasia, Pyrexia, Rebound Effect, Renal Hypertrophy, Restlessness, Single Umbilical Artery, Small for Dates Baby, Somnolence, Somnolence Neonatal, Suicide Attempt, Tachypnoea, Talipes, Tracheomalacia, Tremor, Tremor Neonatal, Vaginal Haemorrhage, Vomiting, Vomiting Projectile

Lorazepam 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.
Apgar Score Low	A system of assessing the general physical condition of a newborn infant based on a rating of 0, 1, or 2 for five criteria: heart rate, respiration, muscle tone, skin color, and response to stimuli. The five scores are added together, with a perfect score being 10. The persistence of low Apgar scores at 20 minutes of age is predictive of high rates of morbidity (disease) and mortality (death). (Virginia Apgar (1909–1974), American physician)
Atrial Septal Defect	An atrial septal defect (ASD), a congenital defect, occurs when there is an opening in the atrial septum, or dividing wall between the two upper chambers of the heart, known as the right and left atria. Normally, oxygen-poor (blue) blood returns to the right atrium from the body, travels to the right ventricle, then is pumped into the lungs where it receives oxygen. Oxygen-rich (red) blood returns to the left atrium from the lungs, passes into the left ventricle, then is pumped out to the body through the aorta. An atrial septal defect allows oxygen-rich (red) blood to pass from the left atrium through the opening in the septum, and then mix with oxygen-poor (blue) blood in the right atrium. This heart defect can cause lung problems if not repaired. When blood passes through the ASD from the left atrium to the right atrium, a larger volume of blood than normal must be handled by the right side of the heart, causing the right side to become overworked and enlarged. Extra blood then passes through the pulmonary artery into the lungs, causing higher pressure than normal in the blood vessels in the lungs, a condition known as pulmonary hypertension.
Cervical Incompetence	A condition in which a pregnant woman's cervix begins to dilate (widen) and efface (thin) before her pregnancy has reached term. Cervical incompetence is a cause of miscarriage and preterm birth in the second and third trimesters.
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.
Craniosynostosis	Craniosynostosis is a defect in which one or more of the flexible and fibrous joints (cranial sutures) between the skull bones closes too soon; it occurs before birth or within a few months after birth. The skull cannot expand normally with growth of the brain, and so assumes an abnormal shape. [Images]
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. [Image]
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.
Foetal Distress Syndrome	An abnormal condition of a fetus during gestation or at the time of delivery, marked by altered heart rate or rhythm and leading to compromised blood flow or changes in blood chemistry.
Hyperphagia	An abnormally increased appetite for and consumption of food, thought to be associated with a lesion or injury in the hypothalamus.
Hypersomnia	Excessive sleepiness.
Laryngomalacia	A birth defect that causes the tissues around the larynx to partially collapse and narrow the air passageway, causing noisy breathing.
Meningomyelocele	Protrusion of the spinal membranes and spinal cord through a defect in the vertebral column. [Images]
Microcephaly	Abnormal smallness of the head. [Images]
Neonatal Respiratory Distress Syndrome	Respiratory distress syndrome (RDS) of the newborn, also known as infant RDS, is an acute lung disease present at birth, which usually affects premature babies. Layers of tissue called hyaline membranes keep the oxygen that is breathed in from passing into the blood. The lungs are said to be "airless." Without treatment, the infant will die within a few days after birth.
Neonatal Tachypnoea	Abnormally fast or deep respiration, which results in the loss of carbon dioxide from the blood, thereby causing a fall in blood pressure, tingling of the extremities, and sometimes fainting.
Oligohydramnios	A deficiency in the amount of amniotic fluid.
Potter's Syndrome	A combination of birth defects characterized by the absence of one or both kidneys, underdeveloped lungs, and Potter's facies, and resulting in neonatal respiratory distress, circulatory abnormalities, acidosis, cyanosis, edema, and death.
Pyrexia	Fever.
Rebound Effect	Rebound effect is the tendency of a medication, when discontinued, to cause a return of the symptoms being treated more severe than before. The symptom will be more pronounced after the medication is withdrawn than before it was used.
Talipes	Clubfoot is a condition in which one or both feet are twisted into an abnormal position at birth. The condition is also known as talipes. [Images]
Tracheomalacia	Degeneration of the elastic and connective tissue of the trachea.

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 Lorazepam 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".