FDA Proposes Suicide Ideation Warnings for Antidepressant Use in Young Adults
According to the FDA, it is proposing drug companies to update their antidepressant product labeling to include warnings of increased suicidality, defined as “increased risks of suicidal thinking and behavior” in adults ages 18 to 24 during the first two months of treatment. On the other hand, data suggests that adults ages 65 and older have reduced suicidality with antidepressants. This proposal will affect the entire category of antidepressants, and that available information could not exclude a single medication from this increased suicidality risk.
Here’s what one of my (pharma industry) colleagues Steve thinks about the black box warning.
Neurochemistry of Giving, Suicide, and Mood Triggers
Alvaro shares an essay written by a 15-year old on why “Tis better to give than receive” based on the neurochemicals Oxytocin and Dopamine. I liked the description that Oxytocin is a “cuddle” neurotransmitter. Keep in mind that we can give non-material things that can be just as meaningful - hugs, a smile, an act of kindness. That said, when you’re on the receiving end, accept the gift graciously because for some of us, the lesson we are learning is to accept what is given to us.
TherapyDoc asked, “How many signals does it take for SOMEONE to consider a higher level of care?” She answers the question as “Too many” as described by the suicide of college student Chuck Mahoney. Chuck Mahoney showed many signs of impending suicide, but these signs went unheeded. Signs for help - especially serious signs of suicide - often went unheeded because people did not know what to do. I also found the comment section (almost as long as the post itself) interesting, as it contained points of views toward this article, who’s responsible, what could have been done, and some personal experiences. Read more
SSRI Suicide Risk Differs in Age of Patient
Wall Street Journal published on December 6, 2006 the article, “FDA: Antidepressants Lessen Risk of Suicidal Thoughts for Seniors”, stating that the FDA’s review of 372 clinical study data involving 11 antidepressants had shown that antidepressants may increase suicidal risk in adolescents, but this risk decreases in but that in older adults the risk declines.
Currently antidepressants carry a black box warning (reserved for life threatening risk) on the increased risk of suicidal thinking in children and teens who have taken antidepressants. This FDA review included at least 100,000 patients who have taken antidepressants across different age groups. In fact, the FDA suggested that in adults 65 years and older, antidepressants actually had a protective effect against suicide risk. This has to be welcome news to drug companies that manufacture antidepressants, although a new labeling change may not happen anytime soon.