Are warnings on antidepressants backfiring?
Findings published earlier this year indicate that although overall youth death rates did not change significantly between 2003 and 2004, suicide rates increased significantly in this period (Pediatrics 2007;119:345-60). Specifically, the data show that for youth aged 15-19 years, the suicide rate increased during that period by 11%, from 7.3 per 100,000 to 8.2 per 100,000. Similarly, for youth aged 10-14 years, the rate increased by 8%, from to 1.2 to 1.3 per 100,000.
Clearly, we are not in a strong position to draw unambiguous conclusions about the causes of these increases. But they could be related to changes in prescribing practices in the wake of media coverage related to the Food and Drug Administration's warnings about suicidal thoughts and the use of selective serotonin reuptake inhibitors (SSRIs).
In 2004, the FDA mandated labeling for SSRIs after reviewing research that indicated a small increase in suicidal thinking--not actions--among young people who were taking the medications. This sparked sensational media coverage that may have frightened clinicians from prescribing--and families from using--the SSRIs, which can be a life-saving treatment.
As we know, significant decreases in the numbers of SSRI prescriptions for children, adolescents, and other age groups followed the agency's warnings. Because other research has indicated a relationship between the increased use of SSRIs and decreasing suicide rates, the drop in the number of prescriptions is consistent with an increase in suicide rates.
This disturbing increase in the rate of suicide and its relationship to decreasing SSRI prescriptions highlight the tension between effectively informing patients and families about the potential risks of treatment relative to the risks of untreated illness.
In this case, the rate of suicidal thinking for adolescents who were depressed increased by about 2% (from 2% to 4%), indicating that 96% of those treated did not report suicidal thinking. However, the headlines--along with anecdotal reports of adverse drug reactions--spurred a dramatic decline in drug use.
Suicide claims the lives of 30,000 Americans each year, and depression is the leading cause, although it is the most treatable of all mental disorders. Unfortunately, the recognition and treatment rates of depression in primary care, although improved during the last several years, are still too low. A recently released 10-year retrospective study by Mental Health America shows that the percentage of Americans who believe depression to be a serious health problem has nearly doubled, from 38% in 1996 to 72% in 2006. Yet with an estimated 19 million Americans suffering from depression in any given year, and half of all Americans with mental health conditions not seeking treatment, the danger of untreated depression far outweighs any danger associated with antidepressants.
Patients and their families need better education about the dangers of untreated depression, and balanced information to help them understand and make decisions about treatment. It is critical that the FDA craft and test its messages so that they are optimally designed to support decision making by both clinicians and consumers. The goal should be fully informed decision making, including a risk/benefit analysis that addresses the risks of nontreatment.
In addition, nonpharmacologic treatment alternatives should be included, so that consumers and clinicians can achieve an optimal match of patient preferences and available therapies. Not all children and adolescents living with depression need or want an antidepressant, but for many, these treatments can be an effective and even life-saving component of their treatment plan.
Adverse drug reactions can occur with any treatment and have been dramatically reported in the FDA hearings. As with any medication, the use of antidepressants must be carefully monitored. It is therefore essential that patients who are prescribed a medication for heart disease, diabetes, or any serious medical or psychiatric condition be closely followed.
More research is needed to fully understand the underlying causes of the increase in the youth suicide rate, as well as to fully understand the effect of the black box warning on prescribing patterns. However, the increasing rate of adolescent suicide just may be a sobering signal about the importance of carefully communicating the full range of costs, risks, and benefits for antidepressants.
DR. SHORN is president and chief executive officer of Mental Health America, Alexandria, Va.
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|Title Annotation:||Guest Editorial|
|Date:||Jul 1, 2007|
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