Psychiatric Medications: Medications for Mental Illness - Important Warnings When Using Antidepressant Medications

Written by National Institute of Mental Health

References

1. Fenton WS. Prevalence of spontaneous dyskinesia in schizophrenia. Journal of Clinical Psychiatry, 2000; 62 (suppl 4): 10-14.

2. Bowden CL, Calabrese JR, McElroy SL, Gyulai L, Wassef A, Petty F, et al. For the Divalproex Maintenance Study Group. A randomized, placebo-controlled 12-month trial of divalproex and lithium in treatment of outpatients with bipolar I disorder. Archives of General Psychiatry, 2000; 57(5): 481-489.

3. Vainionpää LK, Rättyä J, Knip M, Tapanainen JS, Pakarinen AJ, Lanning P, et al. Valproate-induced hyperandrogenism during pubertal maturation in girls with epilepsy. Annals of Neurology, 1999; 45(4): 444-450.

4. Soames JC. Valproate treatment and the risk of hyperandrogenism and polycystic ovaries. Bipolar Disorder, 2000; 2(1): 37-41.

5. Thase ME, and Sachs GS. Bipolar depression: Pharmacotherapy and related therapeutic strategies. Biological Psychiatry, 2000; 48(6): 558-572.

6. Department of Health and Human Services. 1999. Mental Health: A Report of the Surgeon General. Rockville, MD: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Mental Health Services, National Institute of Mental Health.

7. Altshuler LL, Cohen L, Szuba MP, Burt VK, Gitlin M, and Mintz J. Pharmacologic management of psychiatric illness during pregnancy: Dilemmas and guidelines. American Journal of Psychiatry, 1996; 153(5): 592-606.

8. Physicians' Desk Reference, 54th edition. Montavale, NJ: Medical Economics Data Production Co. 2000.

Addendum (January 2007)

This addendum to the booklet Medications for Mental Illness (2005) was prepared to provide updated information on medications in the booklet and results of recent research on medications. This addendum also applies to the Medications Web page document.

Antidepressant Medications

Nefazodone — brand name Serzone

The manufacturer discontinued sales of the antidepressant in the U.S. effective June 14, 2004.

FDA Warnings and Antidepressant Medications

Despite the relative safety and popularity of SSRIs and other antidepressants, some studies have suggested that they may have unintentional effects on some people, especially adolescents and young adults. In 2004, the Food and Drug Administration (FDA) conducted a thorough review of published and unpublished controlled clinical trials of antidepressants that involved nearly 4,400 children and adolescents. The review revealed that 4% of those taking antidepressants thought about or attempted suicide (although no suicides occurred), compared to 2% of those receiving placebos.

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This information prompted the FDA, in 2005, to adopt a "black box" warning label on all antidepressant medications to alert the public about the potential increased risk of suicidal thinking or attempts in children and adolescents taking antidepressants. In 2007, the FDA proposed that makers of all antidepressant medications extend the warning to include young adults up through age 24. A "black box" warning is the most serious type of warning on prescription drug labeling.

The warning emphasizes that patients of all ages taking antidepressants should be closely monitored, especially during the initial weeks of treatment. Possible side effects to look for are worsening depression, suicidal thinking or behavior, or any unusual changes in behavior such as sleeplessness, agitation, or withdrawal from normal social situations. The warning adds that families and caregivers should also be told of the need for close monitoring and report any changes to the physician. The latest information from the FDA can be found on their Web site at www.fda.gov.

Results of a comprehensive review of pediatric trials conducted between 1988 and 2006 suggested that the benefits of antidepressant medications likely outweigh their risks to children and adolescents with major depression and anxiety disorders.²⁸ The study was funded in part by the National Institute of Mental Health.

Also, the FDA issued a warning that combining an SSRI or SNRI antidepressant with one of the commonly-used "triptan" medications for migraine headache could cause a life-threatening "serotonin syndrome," marked by agitation, hallucinations, elevated body temperature, and rapid changes in blood pressure. Although most dramatic in the case of the MAOIs, newer antidepressants may also be associated with potentially dangerous interactions with other medications.

continue: Important Warnings When Using Antipsychotic Medications