FDA Issues Statement on Antidepressants
On March 22, the Food and Drug Administration (FDA) issued a Public Health Advisory to highlight the possibility of worsening depression symptoms and suicidal thoughts associated with some antidepressant medications. The advisory urges health providers and individuals taking antidepressant medications to be aware of changing symptoms and behaviors. The FDA has asked pharmaceutical manufacturers to include a warning statement on this potential risk in product labeling. No medications have been banned or or determined to be unsafe.
The advisory included six warnings which are summarized below.
- Individuals taking antidepressants should be closely monitored for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either increases or decreases.
- Patients and heath care providers should carefully evaluate the current treatment plan and watch for symptoms of worsening depression or suicidal thoughts. Options for interventions, including discontinuing or modifying the current drug therapy, should be discussed before the need arises.
- Patients should be aware of symptoms that may indicate worsening depression or an increased risk of suicide. These include anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, severe restlessness, hypomania, and mania. Patients who experience one or more of these symptoms, or other worsening symptoms, should immediately report them to their health care providers. Therapy should be evaluated, and medications may need to be discontinued, when symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.
- If a decision is made to discontinue treatment, some medications may need to be tapered off rather than stopped abruptly. See medication labeling for individual drug products for details.
(Never stop taking your medication or change your dose without talking with your health care provider.)
- Because antidepressants are believed to have the potential for inducing manic episodes in patients with bipolar disorder, there is a concern about using antidepressants alone in this population. Therefore, patients should discuss all symptoms with their health care providers and should be adequately screened to determine if they are at risk for bipolar disorder before initiating antidepressant treatment so that they can be appropriately monitored during treatment. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
- Patients, caregivers, family members, friends should be alert for signs of agitation, irritability, and the other symptoms described above, including suicidal thoughts and worsening depression. Such symptoms should be immediately reported to a health care provider.
The following testimony was submitted on February 2, 2004, to the Psychophar-macologic Drugs Advisory Committee and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee U.S. Food and Drug Administration by Lydia Lewis, President of the Depression and Bipolar Support Alliance.
The Depression and Bipolar Support Alliance (DBSA) appreciates the effort by the Food and Drug Administration (FDA) to assess the occurrence of suicidality in clinical trials for antidepressant drugs in pediatric patients to determine whether federal regulatory action is needed in the clinical use of these products.
DBSA is the leading patient-directed national organization focusing on the most prevalent mental illnesses: depression and bipolar disorder. More than three million people annually request and receive information on depression and bipolar disorder from our non-profit organization. As DBSA President, I can assure the members of these committees that our organization, with more than 1,000 peer-run support groups across the country, has received numerous inquiries from those we serve about possible connections between youth suicides and the use of prescribed medications, particularly Selective Serotonin Reuptake Inhibitors or SSRIs.
We recommend to those our non-profit organization serves that individuals must have a full understanding of the kinds of medication they are taking and must become partners with their physicians in their treatment. That is also true for parents with children who are taking SSRIs.
DBSA is concerned that a premature or ill-founded conclusion about SSRIs could lead adolescent patients or their parents to discontinue them without consulting their physicians. If the FDA ultimately determines that warnings should be issued in relation to the use of certain medications, it must make clear to physicians and parents precisely why the warning was issued so that risks and benefits can be thoroughly weighed.
Antidepressants and Suicide
The FDA itself has recognized that to this point, there is no clear association between suicides and the use of antidepressants. Unfortunately, the British Medicines and Healthcare Products Regulatory Agency, in what I believe was a premature and hasty decision, late last year recommended against the use of SSRIs in patients under the age of 18. Ultimately, this decision could actually prove to be harmful for children and adolescents with depression.
Untreated or undertreated mood disorders are the leading cause of suicide in the United States. More than ninety percent of people who take their own lives have suffered from depression or bipolar disorder. Suicide will continue to be a risk for people living with depression until more effective treatments for this highly disabling disorder are found. The key, then, is not to hastily abandon treatments that can help alleviate the symptoms of depression, thus helping to prevent suicide.
The findings of the British regulatory authorities are in direct contrast to recent studies by the American College of Neuropsychopharmacology (ACNP). Among the clinical trials of more than 2,000 youth reviewed by their task force, there were no findings of any statistically significant increases in suicide attempts, self-harm or suicidal thinking related to SSRI use.
This task force, comprised of highly respected medical doctors, psychiatrists and clinicians, further concluded, based on autopsy reports, that suicide was more likely to occur in patients who failed to take their prescribed SSRIs rather than when they were taking their medication properly.
As patients we know the danger of our illness, medication is one of the important tools we use to stay alive in the face of this disabling disease.
In many cases, the use of SSRIs has served to completely turn lives from despair to hope. Take the case of one DBSA constituent, a 22-year-old woman, who wrote this about her SSRI medication:
"I have lived with depression since I was nine years old. In fact, I was placed in a child psychiatric hospital when I was 14. I have been on and off different medications throughout the years and still have good and bad days. I have tried most of the antidepressants out there, and know that it is through this medication that I can survive on a day to day basis. While I still have problems focusing and concentrating on even simple tasks, I have the ability to get up in the morning through my antidepressant."
I believe this advisory committee’s review will be more detailed than that conducted in the United Kingdom. The FDA’s re-examination of twenty studies of eight antidepressants involves more than 4,100 children. This analysis, coupled with the findings of the ACNP, hopefully will assuage any concerns in the medical and patient communities about the use of SSRIs.
In the meantime, there is much more that we can do as a nation to combat depression and bipolar disorder as causal factors in suicide. We must significantly increase available services to meet the needs of at-risk youth and those with mood disorders. The existing level of these services is woefully inadequate. We need to encourage the growth of the number of child psychiatrists in the country and fund a mental health infrastructure that spans primary care, schools, mental health facilities, foster care, social services and the juvenile justice system. We need to better fund research at the National Institutes of Health to find causes and cures for depression and bipolar disorder. We need to remove the barriers that stand in the way of research specifically for Adolescents and Children.
I recognize these issues are not the purview of this advisory committee, but this current review and any ultimate decision by FDA on the use of SSRIs will have a significant impact on an already inadequate mental health care system in this country.
Should treatment options for youth with mood disorders be reduced, particularly if based on unreliable or incomplete data, I fear the effect on the suicide rate among this population.
I urge the advisory committee to reach a sound conclusion with an appreciation of the significant impact that its recommendations will have on treatments available to our youth who live with depression. - Lydia Lewis
page created: May 3, 2006
page updated: August 18, 2006