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Warning: Serious Side Effects may be Overstated


Black box warnings, I’m all too familiar with them. A quick look in the medicine cabinet and you would see why. In fact I’m surprised the door shuts some days. No, I’m not a druggy, by any means. I have problems and frankly who doesn’t? These days, like millions of Americans I find some sort of comfort in pill form. It’s not perfect, but most days you wouldn’t know I had my own problems. It’s unfortunate then that the black box warning labels we see on just about every type of antidepressant may be doing more harm than good.

A new study released shows that U.S. Food and Drug Administration warnings about a potential danger for young people taking antidepressants may have backfired, causing an increase in suicide attempts by teens and young adults. You read that right, we got warnings about the side effects, but because of those warnings there was a dramatic drop in the use of antidepressants and with it a rise in suicides.

The original 2003 warnings drew intense and as with anything exaggerated media coverage that led to a sudden, steep decline in the number of prescriptions for antidepressants. In the study, it was reported that in the year following the warnings, when antidepressant prescriptions fell by more than a fifth among young people, there was a relative increase of 21.7 percent in suicide attempts by overdose with psychotropic drugs, and 33.7 percent among young adults.

“This study is a one of the first to directly measure a health outcome driven by the interaction of public policy and mass media,” said Christine Lu, HMS instructor in population medicine at Harvard Pilgrim Health Care Institute and lead author of the study. “The FDA, the media and physicians need to find better ways to work together to ensure that patients get the medication that they need, while still being protected from potential risks.”

“This is an extraordinarily difficult public health problem, and if we don’t get it right, it can backfire in serious ways,” said co-author Stephen Soumerai, HMS professor of population medicine at Harvard Pilgrim Health Care Institute.

In 2003, an analysis that combed through all the existing clinical trials noted that approximately 1 percent of adolescents and young adults taking antidepressants experienced an increase in thinking about suicide.The original warning –which was heavily publicized in news reports– mentioned only this potential risk of antidepressants to patients without noting the potential risk of under [or lack of] treatment of depression.

These well-intended safety warnings became frightening alarms to clinicians, parents and young people, what made things even worse was many prominent media outlets warning that these drugs raised the risk of suicide. However, the FDA-cited studies showed only an increase in the risk of suicidal thoughts, not in attempted or completed suicide. In fact, as more young people were prescribed antidepressants in the years before the warning was issued, suicide attempts by young people were stable according to the researchers.

Because of this the FDA later revised the warning to recommend that physicians consider both the risk of prescribing the medication and the risk of not prescribing the medication, monitoring patients for thoughts of suicide and treating them as needed. Still, many different types of people ended up without proper treatment because of these warnings, despite the benefits and the serious need for care.

The risks cited by the FDA were about 1 percent of those treated, but antidepressant use dropped suddenly by about a relative 20 percent, unintentionally leaving many depressed young people without any sort of treatment, this event  likely drove the accompanying hospital and emergency department admissions for suicide attempts.. The researchers analyzed claims data for the years 2000 to 2010 from 11 health plans in the U.S. Mental Health Research Network, using a “virtual data warehouse” with anonymous patient data organized to facilitate sharing and data comparison between health systems. The study cohorts included 1.1 million adolescents, 1.4 million young adults and 5 million adults.

The researchers used overdose with psychotropic drugs as a conservative measure of suicide attempts. Completed suicides are very rare, so the researchers were not surprised to find no change in their 7.5 million patient sample.They noted that suicide attempts with drug overdose are very serious, resulting in long-term hospitalization and significant disruption to the lives of patients and their families.

At the end of all of this is the actual people who are suffering from depression– between the stigma of mental illness and not knowing if medication will help– many people are left to wonder where they can actually go for help… that is if they even want help at that point. We all have our reasons for needing help sometimes. Unfortunately I can’t say that life is never bad enough to want to commit suicide– I know first hand just how bad it can feel– but it doesn’t mean there isn’t help and hope… no matter how faint.

Don’t believe everything you read on the internet? Good on you, you probably want the full study then. You can find that —here!

Lu, C., Zhang, F., Lakoma, M., Madden, J., Rusinak, D., Penfold, R., Simon, G., Ahmedani, B., Clarke, G., Hunkeler, E., Waitzfelder, B., Owen-Smith, A., Raebel, M., Rossom, R., Coleman, K., Copeland, L., & Soumerai, S. (2014). Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study BMJ, 348 (jun18 24) DOI: 10.1136/bmj.g3596

2 responses

  1. Oh god … another thing we can fear

    June 19, 2014 at 1:30 pm

    • The only thing we have to fear is fear itself.

      June 21, 2014 at 6:09 pm

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