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| 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 (WELLBUTRIN, ZYBAN) | 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.
