This article is no longer current. For the most recent information on children's health, see FDA's Kids Page on this Website. At the same time, the agency began a public education campaign to carry the warning to parents and other care-givers. The measures would eliminate unnecessary risks faced by children when treated with drugs primarily tested in adults.
Most prescription drugs lack information about proper use in children.
The agency has since drafted electromagnetic compatibility guidance for all breathing monitors. These actions were taken after FDA determined that EMI was responsible for more than 40 deaths of infants using the devices. In response to EMI with other medical devices, including motorized wheelchairs and scooters, pacemakers, and anesthesia monitors, FDA is initiating steps to require medical device manufacturers to design and test their products to ensure they function safely and effectively within their intended use environment. The agency is also working with manufacturers and voluntary standards organizations to develop electromagnetic compatibility standards for all medical devices. Following procedures it established to implement the Prescription Drug User Fee Act of 1992, FDA provided expedited review of dornase alfa and approved the biologic in 1993 as the first product in 30 years specifically to treat cystic fibrosis.