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FDA ORDERS BLACK BOX WARNING
On October 15, 2004, the U.S. Food & Drug Administration (FDA) directed the manufacturers of all antidepressant medications to add a "black box" warning that describes the increased risk of suicide and suicidal thoughts and behavior in children and adolescents given antidepressant medications.
The "black box" warning is the strongest prescription drug labeling warning the government can order.
The new warning includes the following points:
- Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorders and other psychiatric disorders.
- Anyone considering the use of an antidepressant in a child or adolescent for any clinical use must balance the risk of increased suicidality with the clinical need.
- Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior.
- Families and caregivers should be advised to closely observe the patient and to communicate with the prescriber.
- A statement regarding indicating whether the particular drug is approved for any pediatric indication and, if so, which one(s). (Currently, Prozac is the only antidepressant approved by the FDA for use for treating depression in pediatric patients.)
The new warnings will be carried by all antidepressants, including Anafranil, Aventyl, Celexa, Cymbalta, Desyrel, Effexor, Elavil, Lexapro, , Ludiomil, Luvox, Marplan, Nardil, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron, Sarafem, Serzone, Sinequan, Surmontil, Symbyax, Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.
The FDA's decision to order the warning comes at a time when both the FDA and pharmaceutical industry have faced severe public criticism for failure to take action sooner when faced with warning signs concerning antidepressants as well as other drugs.
In March 2005, the FDA set a thirty day deadline for antidepressant manufacturers to comply with the October 2004 request to add the black box warning labels. One warning will say that about 2 in 100 children taking antidepressants are more likely to think about or try suicide because they're on the pills. The FDA has also ordered the antidepressant manufacturers to produce "medication guides" about proven risks and benefits of antidepressants. The guides will be given to everyone picking up antidepressant prescriptions.
In December 2006, an FDA panel recommended the agency extend its black box warning to alert patients and doctors that antidepressants can increase the risk of suicidal thoughts and behavior in young adults in their late teens and 20s. The decision to extend the antidepressant suicide warning came after the FDA's review of 372 clinical
trials which found the risks were related to age and the dangers
seemed to disappear at age 25. The review found a small but significant risk of suicidal thoughts and behavior
among 18- to 24-year-olds who took antidepressants. The agency said
that four of 1,000 patients were at increased risk.
STUDIES SHOW ANTIDEPRESSANT PATIENTS FACE TWICE THE RISK OF SUICIDAL BEHAVIOR
According to the FDA Commissioner, Lester M. Crawford, the FDA's decision to order the "black box" antidepressant suicide warning is based on the latest and best science. The new label warning cites the studies of five selective serotonin reuptake inhibitors (SSRIs) (Celexa, Prozac, Luvox, Paxil and Zoloft) and four "atypical" antidepressants (Wellbutrin, Remeron, Serzone and Effexor XR). The studies comprised a total of 24 trials with over 4,400 child and adolescent patients and revealed that a greater risk of suicidal thinking or behavior (suicidality) during the first few months of treatment among those receiving antidepressants. The average risk of such events on drug was 4 percent, twice the placebo risk of 2 percent. No suicides occurred in these trials. Researchers found Celexa, Prozac and Zoloft posed lower risks for children, while Luvox, Effexor and Paxil had higher risks of increased suicidal thoughts and behavior.
Independent experts, working with Columbia University, found on average, 2 percent to 3 percent of children taking antidepressants have increased suicidal thoughts. FDA TAKES STEPS TO MAKE CHILD ANTIDEPRESSANT USE SAFER
Recognizing
that depression and other psychiatric disorders in children and adolescent patients can have significant consequences if not appropriately treated, the FDA continues to believe that antidepressant drugs can provide significant benefits when used appropriately. Consequently, the new warning language does not prohibit the use of antidepressants in children and adolescents, but rather warns of the risk of suicidality and encourages prescribers to balance this risk with clinical need.
In addition to the black box warning, the FDA has also announced that it is in the process of developing a user-friendly Patient Medication Guide (MedGuide), which will be given to patients receiving the drugs to advise them of the risk and precautions that can be taken. Parents will be advised to look for warning signs in children , including worsening depression, agitation, irritability, and unusual changes in behavior. Such signs could come within the first months of starting an antidepressant or when the drug's dosage is increased or decreased. To ensure that patients receive the Medication Guide, the FDA announced it will work with manufacturers to develop "unit of sale" packaging for all antidepressants. In "unit of sale" packaging, a medication is distributed in its original container and pre-labeled by the manufacturer.
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