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FDA: All Antidepressants Should Carry Warnings About Risks of Suicidal Thoughts in Young Adults

Worst Pills, Best Pills Newsletter article July, 2007

 

Do not stop the use of any antidepressant medication without first consulting the prescriber.

 

All antidepressant manufacturers should warn the public about an increased risk of suicidal thinking and behavior in young adults who begin taking the drugs, according to new recommendations from the Food and Drug Administration (FDA).

The FDA announced May 2 that it will require new warnings concerning the increased risk of suicidal thoughts and...

 

Do not stop the use of any antidepressant medication without first consulting the prescriber.

 

All antidepressant manufacturers should warn the public about an increased risk of suicidal thinking and behavior in young adults who begin taking the drugs, according to new recommendations from the Food and Drug Administration (FDA).

The FDA announced May 2 that it will require new warnings concerning the increased risk of suicidal thoughts and behavior in young adults ages 18 to 24 during the first one to two months of treatment with antidepressants. The agency wants the new warnings to be “black box” warnings printed on the professional product labels (or package inserts) for all antidepressants sold in the US. The warning is an amendment to an existing black box warning for children and adolescents. (A black box warning is the strongest type of warning that the FDA can request from a drug manufacturer. The proposed warning accompanies this article.) 

The proposed warning also would state that scientific evidence does not show this increased risk in adults older than 24, and, according to the FDA, those 65 and older using antidepressants have a decreased risk of suicide. The evidence that the increased risk is not present in adults older than 24 is not very strong.
The changes would apply to all antidepressants now on the market. A list of these drugs accompanies this article.

According to the FDA, antidepressant manufacturers will have 30 days to submit their revised professional product labeling to the FDA for review. Manufacturers have also been asked to update their patient medication guides for these drugs to reflect the same concerns of suicidal thoughts in patients under the age of 24. Medication guides are FDA-approved written information that must be distributed to consumers by pharmacists each time an antidepressant prescription is dispensed. 

 

Products Affected by New Black Box Warning Requirement
Generic Name (BRAND NAME) Generic Name (BRAND NAME)
Amitriptyline (ELAVIL) Maprotiline (LUDIOMIL)
Amitriptyline and Chlordiazepoxide (LIMBITROL) Mirtazapine (REMERON)
Amitriptyline and Perphenazine (ETRAFON, TRIAVIL) Nefazodone (SERZONE)
Amoxapine (ASENDIN) Nortriptyline (AVENTYL, PAMELOR)
Bupropion (WELLBUTRINZYBAN) Olanzapine and Fluoxetine (SYMBYAX)
Citalopram (CELEXA) Paroxetine (PAXIL, PEXEVA)
Clomipramine (ANAFRANIL) Phenelzine (NARDIL)
Desipramine (NORPRAMIN) Protriptyline (VIVACTIL)
Doxepin (SINEQUAN) Quetiapine (SEROQUEL)
Duloxetine (CYMBALTA) Selegiline (EMSAM)
Escitalopram (LEXAPRO) Sertraline (ZOLOFT)
Fluoxetine (PROZAC, SARAFEM) Tranylcypromine (PARNATE)
Fluvoxamine (LUVOX) Trazodone (DESYREL)
Imipramine (TOFRANIL-PM, TOFRANIL) Trimipramine (SURMONTIL)
Isocarboxazid (MARPLAN) Venlafaxine (EFFEXOR)

What You Can Do
  
People of all ages should be monitored closely with antidepressants after the drugs are first prescribed, switched or when the dosage is changed.

Do not stop using any antidepressants without first consulting the prescriber.

 

FDA Generic Black Box Warning
 
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [insert name of antidepressant] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. [insert name of antidepressant] is not approved for use in pediatric patients.

The previous sentence would be replaced with the sentence, below, for the following drugs: Prozac: Prozac is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD). Zoloft: Zoloft is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). Fluvoxamine: Fluvoxamine is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD).