enamel of children under the age of 8. It has been proven that bone growth of children is altered when given doses of tetracycline, therefore, causing growth development problems. The use of oxygen therapy to improve breathing for babies in incubators was a widely accepted treatment as far back as the 1930s. In the 1940s, increases in dosage and length of exposure of oxygen were gradually accepted without safety research. The incidence of retrolental fibroplasia suddenly increased, but it was suggested that prematurity of the babies was the cause of the condition. Years later there was a definitive study that linked increased oxygen use with the development of retrolental fibroplasia and blindness in premature babies (Zito, 2008). References AAP updates policy on off-label drug use in children. (2014). Reactions Weekly, 1492(1), 3-3. doi:10.1007/s40278-014-9312-3 Patz A: The role of oxygen in retrolental fibroplasia. Pediatrics. 1957, 19: 504-523. Radley D.C., Finkelstein S.N., Stafford R.S. Off-label prescribing among office-based
physicians. Arch Intern Med. 2006;166(9):1021–1026. Siu A, Thigpen J. Principles of Pharmacotherapy in Pediatrics. In: Arcangelo VP and Peterson AM, editors. Pharmacotherapeutics for Advanced Practice: A Practical Approach. 3rd edition. Philadelphia, PA: Lippincott Williams & Wilkins, 2013: 49-59. Stanford University Medical Center. (2008). 14 Drugs Identified As Most Urgently Needing Study for Off-label Use. Science Daily. Retrieved February 7, 2018, from Wittich, C. M., Burkle, C. M., & Lanier, W. L. (2012). Ten Common Questions (and Their Answers) About Off-label Drug Use. Mayo Clinic Proceedings, 87(10), 982–990. Zito Julie M. (2008). Off-label psychopharmacologic prescribing for children: History supports close clinical monitoring: Child and Adolescent Psychiatry and Mental Health 20082:24 retrieved from COLLAPSE INITIAL POST Off-Label Drug Use in Pediatrics The term ‘off-label’ refers to a drug that its usage is not specified in the FDA's approved packaging label. It occurs in the case of rare diseases and cancer when all other approved options have been exhausted and yielded unproductive results. An example of Off-label prescription is indicated when a drug which is not FDA approved for a child’s diagnosis or age is being taken by the child (WebMD, n.d). Off-label prescription lack information and has been associated with adverse drug events because vital information regarding the drug’s efficacy, proper use, dosing criteria, drug-drug interactions and medication safety are usually omitted (Bazzano et al., 2009). As much as possible, it is advisable to use drugs that have FDA approval. Whenever providers decide to use off-label prescriptions, they are expected to show the benefit and reason for their choice (Mayhew, 2009). However, some medications like Albuterol which were previously used as off-label medications in children indicated serious side effects associated with their use. For example, Cisapride used as an off-label medication in neonates for gastric motility; Promethazine received a black box warning for
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