FDA Seeks New Antidepressant Warning
The FDA proposed Wednesday that antidepressant makers extend "black box" warning labels on antidepressants to young adults, age 18 to 24, CBS News correspondent Nancy Cordes reports.
The labels, which warn that users should be monitored very closely in the first one or two months for an increase in suicidal behavior, previously applied only to those under 18.
The FDA says the proposal was necessary because studies showed that young people age 18-24 seemed to have the same reaction to starting new anti-depressants as those under 18 — a slight increased risk for suicidal thoughts and behaviors in the first couple of months.
Not everyone will agree with this decision. In February, a study found that after years of decline, teen suicide jumped 20 percent in 2004, right after the warning labels were placed on antidepressants.
A leading theory for the rise in suicides is that the warning labels made doctors more reticent to prescribe antidepressants to young people — prescriptions to those under 18 dropped 20 percent after the labels were put in place
The proposed labeling changes also would note that studies have not shown this increased risk in adults older than 24, and that adults 65 and older taking antidepressants have a decreased risk of suicidal thoughts and behavior, it said.
The proposed expanded warnings emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
"Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks," said Dr. Steven Galson, the FDA's drugs chief.
The proposed changes came with the endorsement of FDA expert advisers. Some experts have argued that the changes are overdue, while others maintain they could keep drugs from those who need them.
Last month, a comprehensive analysis of antidepressants for children and teenagers found the benefits of treatment trump the small risk of increasing suicidal thoughts and behaviors in some patients. The Journal of the American Medical Association study also found that risk is lower than what the FDA identified in 2004, the year the agency warned the public about the risks of the drugs in children.
"Depression is a serious problem that can lead to suicide. As with so many other medical problems, it can be extremely difficult to identify the settings in which the benefits of medication outweigh the possible risks," says CBS News medical correspondent Dr. Jon LaPook. "Whatever the therapy, close medical follow-up is a crucial part of the treatment of depression. This is especially true in patients who have been prescribed medications."
The proposed label changes would apply to all antidepressants, including Lexapro (Forest Laboratories Inc.), Paxil (GlaxoSmithKline PLC), Prozac (Eli Lilly and Co.) and Zoloft (Pfizer Inc.). Some of the drugs are available in generic form as well.
Messages left with the companies were not immediately returned.