June 20, 2014
News Review From Harvard Medical School -- Suicide Attempts Up after Antidepressant Alerts
Teens and young adults took fewer antidepressants after the drug labels started warning about an increased suicide risk. And they also were more likely to attempt suicide, a new study says. The U.S. Food and Drug Administration (FDA) first required the warnings in 2004. They applied to antidepressants called selective serotonin reuptake inhibitors (SSRIs). These drugs include fluoxetine (Prozac), paroxetine (Paxil), citalopram (Celexa) and others. In 2007, the warning was expanded to include young adults. The new study used data from 11 U.S. health plans. Researchers looked at prescriptions for SSRI drugs. They also looked at cases of overdose with mind-altering drugs, such as tranquilizers and amphetamines. Researchers said overdoses were more likely to be reported consistently than the medical code for suicide attempts. Use of SSRIs dropped 31% for teens and 24% for young adults in the second year after warnings were posted. Overdoses, considered to be suicide attempts, rose 22% among teens and 34% among young adults. The FDA now says doctors should weigh the risks of the drugs against the risk of not treating depression. The journal BMJ published the study online. HealthDay News wrote about June 19.
By Howard LeWine, M.D.
Harvard Medical School
What Is the Doctor's Reaction?
The Food and Drug Administration (FDA) often needs to release warnings about drugs based on reports from doctors of potential side effects.
Sometimes the warnings turn out to be right on target. In that case, they are later supported by scientific evidence. For example, the warning about aspirin use in children with high fever was based at first on reports. It surely prevented many cases of a devastating brain condition called Reye syndrome.
But other times, scientific studies done later don't support the FDA warning. Rarely, the warning can have harmful results. As these study results show, this is what happened after a warning about SSRIs.
SSRI stands for selective serotonin reuptake inhibitors. These are the antidepressants prescribed most often. These drugs are very effective for many people and generally well tolerated.
Between the years 1999 and 2004, primary-care doctors and pediatricians were getting more comfortable diagnosing depression. Diagnoses increased steadily in all age groups, especially in teens and young adults. During the same period, there was a parallel increase in the number of antidepressant prescriptions.
In 2003, the FDA began to alert doctors to a potential increase in suicide risk among children and teens when starting an SSRI. In 2004, the FDA raised even more concern about SSRI drugs. The agency mandated a warning on SSRI labels.
Within months, the number of new depression diagnoses started to fall. It continued to fall quite dramatically in the years after. And so did the number of new prescriptions for antidepressant drugs. The FDA added more fuel to the concern about SSRIs in 2007. That's when it expanded the warning about suicide to include young adults.
Certainly the FDA had not intended to make depression treatment less available to those who needed it. The FDA wanted doctors to alert patients that they should immediately report any feelings of wanting to hurt themselves.
But many doctors and the public interpreted the FDA warning differently. The message heard was that starting an antidepressant increased the risk of suicide.
Was the warning about SSRIs justified? Even if it was justified, should it have been presented very differently to doctors and the public?
Even in retrospect, the FDA was right to alert doctors of the potential problem. There were enough reports of suicide attempts soon after starting an SSRI to justify making doctors aware of this relationship. But the FDA could have done a much better job of explaining that this did not mean SSRIs caused more suicide attempts.
In fact, these new study results suggest the SSRI warning may have done more harm than good. The warning was justified. But it should have put more emphasis on a different message.
The message: Anyone with a new diagnosis of depression needs to be alerted to the possibility of increased suicidal thoughts. This can occur even if no drug therapy is started. And patients need to know they should report those thoughts immediately. When possible, family members also should be alerted.
What Changes Can I Make Now?
Antidepressants are still an effective and relatively safe treatment for depression. That's especially true compared with the alternative of no care at all. But drug treatment must be done with proper monitoring.
Depression treatment does not always mean taking medicines. With mild to moderate depression, talk therapy can work as well as drugs for many people.
If an antidepressant medicine is needed, an SSRI is still an excellent first choice.
What Can I Expect Looking to the Future?
It likely won't happen quickly. But during the next few years, more people with depression will once again be diagnosed and receive the treatment they need.
The really good result from this story is the renewed emphasis on the need to immediately report suicidal thoughts. This advice should apply whether or not a new drug is started.