The Use of Prescription Drugs in Children

“In June 2003, the U.S. Food and Drug Administration, following the lead of its British counterpart, issued warnings specifically about Paxil, saying no one under age 18 should be prescribed the drug for major depression because it might increase a child's risk of suicide. […] Mary Anne Rhyne, a GlaxoSmithKline spokeswoman, told The Star-Ledger that the sales force was told not to discuss the safety concerns because Paxil was approved only for use in adults. ‘Our sales reps are prohibited from discussing, sharing or leaving behind off-label information with health-care providers,’ Rhyne told the newspaper. Deviations from officially approved uses are called off-label use. But like many drugs officially approved only for use in a particular group of patients or for a specific disease, doctors sometimes prescribed Paxil for people under age 18. An official with the FDA's Office of Drug Safety told an advisory panel meeting two weeks ago that 8 percent of all antidepressant prescriptions in the first half of this year were for people under 18.” (Paxil warning Suppressed, The Associated Press, September 2004, http://newsobserver.com/business/story/1686138p-7930169c.html)

The Use of Prescription Drugs in Children