Congenital defects/anomalies

In 1976, a final report from the International Register of Lithium Babies contained information on 225 infants exposed to lithium in the first trimester. Cardiovascular anomalies occurred in 18 (8%) of the newborns, of which 6 (2.7%) had Ebstein s anomaly (Weinstein, 1976). A comprehensive review of this report and the multiple studies that have been conducted since (Cohen et ah, 1994) revealed that the risk of congenital defects after in utero exposure to lithium is less than previously anticipated. Currently, the risk for Ebstein s anomaly after first-trimester exposure to lithium is estimated to be 1 in 1000 (0.1%) (Altshuler et ah, 1996), or 10-20 times greater than the general population risk of 1 in 20,000 (Weinstein, 1976). Thus, the absolute risk for Ebstein s anomaly is small. 

Development Effects. Anecdotal data have suggested a link between chronic gasoline vapor exposure of pregnant women and congenital defects of the central nervous system in their children. In utero exposure to leaded gasoline was found to cause retarded development and anomalies of head and muscles in two children (Hunter et al. 1979). Based on the limited available data, the study was considered inadequate to establish a relationship between inhalation exposure to gasoline and human development toxicity. 

The presence of congenital defects in the coronary arteries is infrequent ( 1% of the cases), but only a small proportion of them are accompanied by symptoms, generally angina or dyspnoea. The diagnosis of these anomalies has been facilitated by the frequent performance of multislice... 

Developmental anomalies of the ovaries are very rare. Although ovaries have a different developmental origin from uterus and fallopian tubes, ovarian anomalies are significantly more often associated with congenital uterine anomalies (22%), particularly with unicornuate uterus [16]. Uterus and fallopian tubes develop from the paramesonephric ducts. Defects of the paramesonephric tubes result not only in abnormalities of the uterus but also of tbe fallopian tubes, kidneys, and ureters. 

Craniofacial malformation are common features of FAS, which impairs the normal development of the skull, jaws, teeth, nose, eyes, and facial skin. Sometimes variable anomalies of limbs and joints are present, including congenital hip dislocations, abnormalities of the toes, and inability to extend completely the elbows or metacarpal phalangeal joints. Cardiac malformations syndrome encompasses an atrial septal defect, a patent ductus arteriosis, and cardiac murmurs representing ventricular septal defects. Anomalies of external genitalia have also been noted. 

Minor anomalies were related to lead level in the Boston study (Needleman et al, 1984) but not in the Port Pirie (McMichael et al, 1986) or the Cleveland (Ernhart et al, 1986) studies. While there were a number of methodological differences between the Boston and the Cleveland studies, one discrepancy in findings that may be meaningful is that the Boston group failed to find an association between their alcohol-use measure and neonatal anomalies. This is notable, since it has been estimated that 5% of anatomic congenital defects may be attributable to prenatal alcohol exposure (Sokol, 1981). 

A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. 

Any cancers and congenital anomalies or birth defects should also be regarded as serious. 

Nora JJ, Nora HA, Toews WH Lithium, Ebstein s anomaly, and other congenital heart defects. Lancet 2 594-595, 1974... 

Because of the problems that resulted from self-regulation, another law, the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, was approved in 2006. This law requires manufacturers, packers, or distributors of supplements to submit reports of serious adverse events to the FDA. Serious adverse events are defined as death, a life-threatening event, hospitalization, a persistent or significant disability or incapacity, congenital anomaly or birth defect, or an adverse event that requires medical or surgical intervention to prevent such outcomes based on reasonable medical judgment. If this requirement were enforced, and consumers cooperated, these reports would make it possible to identify trends in adverse effects and would help to alert the public to safety issues. 

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