FDA warning on one drug spurs concern over others

FDA action on the use of paroxetine by those younger than 18 brings to light a range of cracks in mental health infrastructure.

By Victoria Stagg Elliott, AMNews staff. Sept. 8, 2003.

The repercussions of a recent announcement by U.S. and British pharmaceutical regulatory agencies are playing out in a new level of debate regarding a range of issues that plague the practice of medicine.

The two government regulators, the Food and Drug Administration and the British Committee on Safety of Medicines, recommended against using one specific antidepressant for patients who are children and adolescents. Since then, the upshot has been a domino effect including renewed calls for all drug research to be made public, especially when funded by a pharmaceutical company, and for more pediatric drug studies.

The actions also have focused on the weaknesses of U.S. mental health care and reopened decades-old questions about the possible link between antidepressants and suicide. Finally, these developments have highlighted the ongoing challenge of studying depression and suicide.

"You can use this case to point out all the total inadequacies of the health care system," said Michael Grodin, MD, a health law professor at the Boston University School of Public Health.

Specifically, the FDA and its British counterpart issued directives in June that paroxetine, an antidepressant marketed here under the brand name Paxil and in Britain under the name Seroxat, no longer should be prescribed to those younger than 18. Both agencies reviewed several studies that showed no efficacy for this age group and an associated increased incidence of self-harm and suicidal thoughts. Both agencies also are analyzing the data to determine if there are any implications for adults.