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FDA Advisory Against Anti-depressants to Be Expanded to Cover Young Adults too

Anti-depressants could indeed lift one out of depression. But its potential to drive teenagers to suicide has already been recognized//.

Now the U.S. Food and Drug Administration (FDA) has proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, in young adults ages 18 to 24 during initial treatment, generally the first one to two months.

Back in March 2004, the FDA had said –

Health care providers should carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either increases or decreases. Although FDA has not concluded that these drugs cause worsening depression or suicidality, health care providers should be aware that worsening of symptoms could be due to the underlying disease or might be a result of drug therapy.

They should carefully evaluate patients in whom depression persistently worsens, or emergent suicidality is severe, abrupt in onset, or was not part of the presenting symptoms, to determine what intervention, including discontinuing or modifying the current drug therapy, is indicated.

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric, it had said then.

Although FDA had not concluded that these symptoms were a precursor to either worsening of depression or the emergence of suicidal impulses, it had expressed concern that patients who experienced one or more of such symptoms might be at increased risk for worsening depression or suicidality.

Antidepressants wo rk by increasing the activity of certain chemicals work in our brains called neurotransmitters. They pass signals from one brain cell to another. The chemicals most involved in depression are thought to be Serotonin and Noradreline.

The Royal College of Psychiatrists notes in the case of drugs that inhibit serotonin receptors, the SSRIs, in the first couple of weeks of taking them, you may feel sick and more anxious.

Some of these tablets can produce nasty indigestion, but you can usually stop this by taking them with food. More seriously, they may interfere with your sexual function. There have been reports of episodes of aggression, although these are rare.

It also says, "There is no clear evidence of an increased risk of self-harm and suicidal thoughts in adults of 18 years or over. But, individuals mature at different rates. Young adults are more likely to commit suicide than older adults, so a young adult should be particularly closely monitored if he or she takes an SSRI antidepressant." Such is the conventional wisdom.

But on Wednesday the FDA asked makers of anti-depressants to expand the warning labels to include adults age 18-24.

Eli Lilly and Co., the maker of Prozac, Zoloft manufacturer Pfizer Inc. and other pharmaceutical companies said they would comply with the FDA's request.

"We believe this step will help ensure that the millions of people with depression who are young adults age 24 and under and their families can make informed treatment decisions while minimizing the fear and stigma associated with depression," Eli Lilly said in a statement.

Pfizer spokeswoman Shreya Prudlo said the company would update its label, which she said already calls for close monitoring of patients when they begin taking Zoloft. She added, however, "There is no established causal link between Zoloft and suicide in adults, young adults or children."

The proposed labeling chang es 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.

The expanded warnings would 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.

Still, any risks are said to be small. For every 1,000 patients 18-24 treated with antidepressants, the FDA would expect there would be five additional patients who have suicidal thoughts or exhibit suicidal behavior, said Dr. Thomas Laughren, who oversees psychiatric drugs for the FDA. The FDA analysis was based on studies of 11 antidepressants in more than 77,000 patients.

The proposed changes came with the endorsement of FDA expert advisers. Some experts have argued that the changes are overdue while others apprehend they could keep drugs from those who need them.
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