antidepressant blackbox warnings under attack again

Its hard to believe that it has been almost ten years since black box warnings were added to antidepressants.   These warnings came 13 years after the FDA first held hearings on link between Prozac and suicide in 1991.

Ever since the FDA mandated black box warnings in 2004, we have been playing whack a mole with non-stop efforts to undermine this warning.   Just this week, there was another “new” study in the BMJ alleging a  link between antidepressant black box warnings and an increase in teen suicidal behavior.  Fortunately, however, there were strong and rapid responses to the seriously flawed BMJ study and there will be others in the coming weeks.

An all too familiar strategy that rolled out on mainstream media such as NBC Today Show, CBS Nightly News, Boston Globe, and Washington Post was used to create hyped up claims that warnings may have backfired leading to increased suicidal behaviors.  It’s no wonder the public is confused.  An excellent analysis in PLOS neuroscience takes both the study and the mainstream media to task.  It offers a good understanding of how health and science media coverage too often just regurgitates what it is given without any critical analysis or study.  Plus, there was no mention of the fact that Prozac is the only antidepressants approved for depression in teens.  The PLOS blogger, psychiatrist Adrian Apreda, urges … “In closing: my hope is that members of the media who cover [medical] debate[s] will realize that “first do no harm” is not only the duty of physicians; it is also the responsibility of anyone trusted with giving health information to the public at large.”

This hits close to home as I (KW), along with several other advocates, worked really hard after the death of my husband in 2003 to get black box warnings added to antidepressants.   Woody was given Zoloft off-label for insomnia and 5 weeks later took his own life without any history of depression or any other mental illness. Of course, the black box warnings may have caused some to think twice about taking these drugs.  Isn’t this a good thing?  Antidepressants are serious mind-altering drugs and the decision to take them should be weighed carefully.

However, the reality is that there are many conflicting interests at play, and ultimately, the public pays the price.  In my opinion, it’s all in the timing — the PR machine is starting up in advance of the FDA Chantix hearings in October to reverse the psychiatric warnings on this smoking cessation drug.   Articles like the one in BMJ are all part of the insidious process that industry is using now to lay the groundwork for weakening and/or eliminating the warnings.

A new push is on and we need to push back.