Antidepressants to carry warning label - - Columbia, South Carolina |

Antidepressants to carry warning label

(Undated) Oct. 15, 2004 - All antidepressants must now carry a prominent black-box warning that tells doctors these drugs can lead to suicidal thoughts and suicide in children and teenagers.

But Dr. Lester Crawford, acting FDA commissioner says the warning doesn't keep doctors from prescribing the drugs, "The new warning doesn't prohibit doctors from prescribing these drugs. It warns of the risk and encourages prescribers to balance this risk with clinical need."

Though there are instances where children on antidepressants committed suicide. An FDA review of clinical trials involving nine popular antidepressants found no actual suicides and only four percent of children at risk. But that is twice the risk factor for children not on antidepressants.

Eli Lilly, the maker of Prozac, the only FDA-approved antidepressant for children gave the warning, "May have a dangerous effect on appropriate prescribing for patients who urgently need proven treatment options."

Dr. Paramjit Joshi, a leading child psychiatrist at the Children's National Medical Center, agreed, "I've had so many children and patients, my current patients, who said: 'There's so much concern about anti-depressants. Are you going to take my child off this medicine? It's helped them so much. My child is a different child.'"

Because the warning goes to doctors, the FDA is also requiring a reader-friendly patient guide explaining the concern. The FDA also wants manufacturers to re-package their products to make sure every patient gets one. The changes are expected to appear on pharmacy shelves in the next two months.

The irony is when the drugs work, they can actually prevent suicide. According to Eli Lilly, up to 15 percent of people who are clinically depressed will commit suicide when left untreated.

Posted 3:55pm by Eva Pilgrim

Powered by WorldNow