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Antidepressants: Are FDA Warnings Keeping People From Getting Help?

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By David Goguen on June 02, 2009 7:57 AM

Most antidepressant medications come with FDA-ordered "black box" warning labels on their packaging, advising patients and care providers of the potentially deadly side effects of the drugs' use -- specifically, the risk of suicidal thinking and behavior, especially in young patients.

These warnings, while necessary, may also raise a barrier of fear and apprehension that's keeping adults and children from getting help for serious mental health problems, according to a study released this week.

Trends in Warnings and Diagnosis. The study Persisting Decline in Depression Treatment After FDA Warnings, published in the June issue of Archives of General Psychiatry, traces trends in depression diagnosis and treatment alongside the timeline of FDA warnings on popular prescription antidepressant medications like Celexa, Cymbalta, Paxil, Prozac, Wellbutrin, and Zoloft.

What Did the Study Find? The study concluded that, from the time of the first strong FDA Public Health Advisory linking antidepressants with suicidality in children (in late 2003), through the "black box" warning for pediatric patients (2005) and its extension to young adults (2007), the rates of diagnosis and treatment of clinical depression have declined rather dramatically across all age groups: down 44 percent for kids, 37 percent for young adults, and 29 percent for adults.

Balancing Utility and Risk. When it comes to prescription drugs and their side-effects, from a legal standpoint the issue is usually one of utility versus risk: Is the medication providing enough of a benefit to patients in light of the harm the drug could do? A secondary legal question for regulators and drug companies is: Are we telling caregivers and patients everything we know about the risks associated with a certain prescription drug?

That's why, since 2004, despite the link between use of these drugs and suicidality in younger patients, antidepressant medications have been readily available to the patients who really need them, but have come packaged with imposing "black box" warnings on the potential harm they can cause. Learn more about Pharmaceutical Drug Liability.

Ultimately, the study illustrates how the legal system -- from the FDA's regulatory role in prescription drug safety, to drug companies' desire to protect themselves from lawsuits over indirect harm caused by their products -- can complicate (albeit necessarily) people's perceptions and their decision-making when it comes to getting the help they need.