Monday, June 21, 2004

Antidepressants Restudied for Relation to Child Suicide
New York Times story - "A child stabs himself in the neck with a pencil. Another slaps herself in the face. Is either suicidal? It is a question that has divided psychiatrists and drug regulators the world over and goes to the heart of a fierce controversy over whether antidepressants lead some children to become suicidal. Now four researchers at Columbia University hope to provide an answer. By reclassifying reports of suspect or self-destructive behavior that occurred during tests of antidepressants in youngsters, the research team hopes to clarify whether antidepressants lead children and teenagers to become suicidal. Officials at the Food and Drug Administration say they will use results of the study to help them decide, later this summer, whether the agency should discourage doctors from prescribing the pills to youngsters. The study was commissioned by top F.D.A. officials after they rejected an analysis by one of the agency's top experts that concluded that antidepressants could be dangerous when given to teenagers and younger children. With such a controversial beginning, the study is being met by fierce criticism..." [Viewing New York Times resources requires registration, which is free].  
  

Manufacturer Halts U.S. Sales Of Controversial Antidepressant
Psychiatric News story - "Sidestepping the safety issue, Bristol-Myers Squibb pulls Serzone from the U.S. market, citing decreased sales and generic competition. Critics of the drug are only partly pleased, however. Bristol-Myers Squibb (BMS) announced that this month it would stop manufacturing and shipping its Serzone brand of the combined serotonin-norepinephrine reuptake inhibitor and 5-HT2 antagonist nefazodone. The announcement brings to a close a rocky nine-and-a-half-year run for the antidepressant, which has been tied to serious adverse effects on the liver and played a part in documented medication errors, due to name confusion. BMS cited financial and business concerns for the decision, noting declining sales since the introduction of generic formulations in September 2003. However, most industry analysts said the company pulled the drug in the face of numerous lawsuits and increasing pressure from regulators to remove the product voluntarily rather than being ordered to do so."