As we approach the new millennium, very little has changed regarding the labeling of prescription drugs for use in infants and children. Along with pregnant women, infants and children remain therapeutic orphans. This condition is understandable because there are very few therapeutic indications that are unique to this patient population and the absolute quantities of drugs required by these patients remains relatively small. On an actuarial basis, humans spend only approximately 16 years as children, whereas they spend another 60 to 80 years as adults. As a result, there is very little incentive for pharmaceutics companies to develop drugs and drug dosing guidelines for infants and children. Careful review has revealed that >70% of all the Physicians' Desk Reference (PDR) entries have either no existing dosing information for pediatric patients or explicit statements that the safety and efficacy in children have not been determined. In the best of circumstances, there are age-specific admonitions because of lack of dosing information for infants and children.

The resulting conundrum can be illustrated best by a case presentation.

	CASE 1

A 6-month-old infant, born 29 weeks premature, presents to a physician's office in respiratory distress. His medical history is significant for developing bronchopulmonary dysplasia as well as for prematurity. Vital signs are temperature: 37.7°C; pulse: 180; respiration: 72; blood pressure: 84/56; physical examination: intercostal retractions, increased anteroposterior diameter, bilateral diffuse expiratory wheezing, nasal flaring; treatment: albuterol 2.5 mg in 2 mL normal saline by nebulization.

While receiving the aerosol, the patient's pulse rate climbs to 215 beats per minutes and he becomes cyanotic despite the O₂ used to nebulize the drug. The physician is called by the nurse and witnesses the patient turn black with eyes rolled back. He then suffers a respiratory arrest. Resuscitation is unsuccessful.

When confronted with a similar clinical emergency, most clinicians would have treated the child in the . . . [Full Text of this Article]