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FDA Orders "Black Box" Warning on Antidepressants Prescribed for Children and Teens
NMHA Provides Guidance for Parents of Teens With Depression

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FDA Orders "Black Box" Warning on Antidepressants Prescribed for Children and Teens

 

The controversy surrounding the use of antidepressants in children came to an official head last month with the FDA's order that SSRIs prescribed for children carry a “black box” label-the strongest warning the agency puts forth-and are accompanied by an informational guide outlining the medications' risks. The decision presents valuable opportunities to educate parents on possible side effects of the drugs but has also spawned confusion among the public, policymakers and the media. Advocates must know the facts and stand ready to face this issue head on.

New Obstacles to Care
It is essential to take precautions that protect children and ensure the safe use of medications. But it is equally important to ensure that we don't deter consumers, parents and doctors from safe prescribing practices, or allow this development to shape mental health policy and funding for services in a detrimental way. As NMHA said in its Sept. 13 testimony before an FDA advisory panel, policymakers must approach safety issues in the broadest possible context to avoid intensifying the stigma surrounding mental illness that already dissuades parents from seeking care for their children. The FDA warning must not present its warning in a manner that would construct barriers to needed care, namely by causing unnecessary fear in parents. Any action that would worsen the public health crisis of untreated mental health disorders in children would be devastating for the one in five children who need mental health treatment.

Advocates Must Respond
Mental health advocates must confront this issue with clear messages that address the misinformation pervading recent media reports.

But we face serious challenges in helping the public, policymakers and the media to understand this issue. For example, alarmed parents across the country have reacted to the agency's decision by pulling their children off the medicationswhich poses risks if done suddenly-and interrupting their treatment plans. Conflicting news stories and negative advertisements are only encouraging such confusion and panic, and stand to discredit the very real threat of untreated mental illness. This defies decades of research and our hard-won strides in improving public understanding of mental health issues.

The confusion surrounding this issue could also endanger state and federal policy. Lawmakers who fail to understand the context of the panel's recommendation may use the data in negative ways to justify or enact policies that further restrict access to SSRIs. More broadly, this issue could affect policymakers' decisions about funding all psychotropic medication, children's mental health services, and other mental health protections and treatments.

The FDA Order: What You Need To Know
NMHA offers advocates the following messages they can use to help clarify this issue among members of the public and the media, and with policymakers:

  • The worst possible situation for children who have mental health problems is to go without treatment.
  • The parents of children diagnosed with depression or other disorder should discuss the risks and benefits of all treatments with a doctor. If antidepressants are prescribed, parents and doctors should monitor the children closelyparticularly in the first few weeks of care.
  • Know the warning signs of suicide, and if a child or adult you know exhibits symptoms, talk to a doctor or mental health professional immediately.
  • No one should abruptly discontinue their children's — or their own— antidepressant use, which can lead to significant side effects.
  • Separate “fact from fiction” by identifying credible sources of information about how antidepressants work and what the real risks are.