Another Psychiatric Drug, Another Black Box Warning

The US Food and Drug Administration (FDA) ordered new "Black Box" warnings for the ADHD drug Strattera which was linked in clinical trials to suicidal thinking, suicidal behaviors, as well as agitation and irritability. The FDA also ordered the drug's labeling to include "additional warning statements that alert health care providers to an increased risk of suicidal thinking in children and adolescents." The new warnings come as part of a larger FDA review of psychiatric drugs and their possible association with suicide, according to the agency. Strattera, chemically "similar to certain antidepressants," belatedly joins a rapidly growing list of psychiatric drugs that carry a Black Box warning, the FDA's most serious warning label.

"It is beyond debate that these drugs have extremely dangerous side effects and that the public has not been adequately informed about these dangers," points out Julian Whitaker, M.D. who was joined by 125 other doctors and medical professionals in a September 21 letter to the FDA, imploring the embattled agency to end its bureaucratic foot-dragging on psychiatric drugs. While the agency ordered Black Box warnings to be placed on all antidepressant drugs in 2004 for patients under 18 years old, such warnings have not gone nearly far enough to protect the US public health.

On September 28, 2005, a study of Paxil indicated that infants born to women taking the SSRI antidepressant drug in the first trimester more than doubled their risk of serious birth defects. With antidepressant sales now passing the $20 billion mark, many question why the FDA continues to approve drugs for supposed "chemical imbalances" that no medical or laboratory tests have ever proven to exist. "With literally billions of dollars of profits at stake, we are not surprised when we hear stories of skewed clinical trials, suppressed study outcomes, pressure placed on reviewers, and a host of other abuses," stated Dr. Whitaker.

Published: September 29, 2005
Author: Marla Filidei