Drug Testing in Children: Fda Regulations

Abstract

The testillg of drugs for use ill cilildren is difficult to accomplish, and it is even difficult to write about. Anything that smacks of "experimentation" on a child or even the use of a placebo given to a sick child is an emotionally charged subject. To carry out procedures that cannot be considered as essential to therapy, especially when they are painful or tiresome, seems abhorrent. However, it is recognized that the effects of many drugs on children may vary considerably from the effects on adults even when careful calculation is made to arrive at a dosage proportional to the body weight or estimated body surface area. Pharmacologically, children cannot be regarded as little adults. Intensified, or toxic effects of drugs administered to children, especially infants, may reflect immaturity in enzymatic mechanisms for drug metabolism, as well as other detoxification and excretory functions. In view of these circumstances, there is need for special caution in prescribing medication in the treatment of childhood disorders, particularly when the medication is used for an extended period of time or when a newly marketed drug is employed. Even greater caution is needed with the use of a new drug under investigation, in advance of approval for marketing. Known serious adverse effects of drugs in children include the effects of sex hormones on growth, steroids on genital development, and antibiotics on tooth enamel. According to the regulations of the Food and Drug Administration, a drug which has not been subjected to investigation in children may not be labeled for use in pediatric therapy.

Acetaminophen causes neurodevelopmental injury in susceptible babies and children: no valid rationale for controversy

“…In adults, the liver was identified as the target of APAP toxicity in the 1960s [ 6 - 8 ]. At that time, however, the view that babies metabolize drugs identically to adults was already known to be an unreliable and potentially dangerous assumption [ 9 ]; this knowledge had yet to be applied to the toxicity of APAP in children [ 5 ]. More than a decade later, a study using laboratory animals demonstrated that this assumption probably did not apply to APAP metabolism [ 10 ].…”

Acetaminophen Causes Neurodevelopmental Injury in Susceptible Babies and Children: No Valid Rationale for Controversy

“…Indeed, in adults, the liver was found to be the target of acetaminophen toxicity during the 1960s (4)(5)(6). At that time, however, the view that babies metabolize drugs in a manner identical to adults was already known to be a dangerous assumption (7); this knowledge has yet to be applied to the toxicity of acetaminophen in human children (3). More than a decade later, a study using laboratory animals demonstrated that this assumption should not be applied to the metabolism of acetaminophen (8).…”