Psychotropic Drugs Have Potential to Cause Birth Defects

Researchers at the Faculty of Pharmaceutical Studies at University of Copenhagen (UC) have found that children of pregnant women who use psychotropic medications are at an increase risk of birth defects. UC Professors Lise Aagaard and Ebba Hansen’s study investigating the adverse drug reactions of psychotropic medications on children 17 years and younger over a ten-year period is available in the open access publication BMC Research Notes (//

Concerned about the rapid incline of psychotropic medications being prescribed to the pediatric population and the varying risks of these drugs, Aagaard and Hansen set out to map all reports of adverse drug reactions among the Danish pediatric community that were associated to psychotropic medicines. Prior to their investigation, very little was documented on the severe side effects caused by these particular medications, aside from individual accounts. Using Denmark’s national Adverse Drug Reaction database, the researchers gathered all reports on adverse drug reactions caused by psychotropic medications among children from birth to age 17 that occurred between 1998 and 2007.

In their study, the researchers considered such factors as the type of psychotropic medication involved, the frequency that side effects were recorded, the severity of the child’s side effect, the child’s age, and gender in all adverse drug reaction reports. Of all 429 psychotropic adverse drug reactions involving children reported during this time period, around 56% of them were considered to be serious conditions. One-half of psychotropic adverse drug reactions occurred in adolescents and involved either antidepressants or psychostimulant medications. About 60% of all adverse drug reactions occurred in males, and 40% of all cases were related to either nervous disorders or psychiatric disorders. Most disconcerting however, was that approximately 20% of all psychotropic adverse drug reactions occurred in children between the time of birth to the age of 2, and nearly all of these cases were classified as serious conditions—involving birth deformities, severe withdrawal syndromes, and two proving fatal. Researchers found that the cause of the reactions in these babies was due to the mother’s use of psychotropic medications during pregnancy.

Within the adverse drug reaction reports, researchers discovered such conditions as premature birth, low birth weight, birth deformities, and neonatal withdrawal syndrome among children under 2 years of age. Researchers believe that these various birth defects were most likely caused by the use of psychotropic medications by pregnant mothers, which include such medications as central nervous system stimulants, antidepressants, tranquilizers, and sedatives. Because these types of drugs are usually high in potency, prescribed in large dosages, and remain in the body’s system for several weeks upon ingestion, pregnant women have the potential of passing on the drug’s side effects to their unborn fetuses. The esearchers conclude that health care providers should better inform their patients of the potential risks involved with these medications, and that necessary precautions more regulation should be taken in special circumstances such as pregnancy.

In total, researchers Aagaard and Hansen found 4,500 pediatric adverse drug reactions had occurred during the decade-long time frame. Of these reports, 42% of adverse drug reactions were associated with psychostimulants (such as Ritalin), 31% were related to antidepressants (such as Prozac), and 24% were caused by antipsychotics (such as Haldol).

Because the prescribing of these medications has become so commonplace among the many nations’ health care systems, the researchers caution that these types of drugs should not be used to treat ordinary conditions. Children may be prescribed psychotropic drugs to treat such medical conditions as attention deficit disorder (ADD), central nervous system (CNS) disorders, and psychiatric disorders. Adults are equally likely to be prescribed these medications, and prescription drug use among all age groups and demographics has inclined globally. In the U.S., prescription drug abuse has become rampant among both adolescents and adults, and mortalities related to nonmedical use of prescription medications has grown five-fold in the last 16 years.

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