FDA Seeks New Antidepressant Warning

Government Wants Drugmakers To Add Warnings On Suicide Risks For Young Adults

(CBS/AP)  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.

[cbslogin12]

Isn't a person with depression much more likely to commit suicide? Depression medications only help people with depression. They do not take the depression away. They are not a happy pill that makes everything all right! But they do, in many cases, greatly help those who are suffering.

[gunownerdan]

Those who think banning guns would work to reduce crime would be better off banning antidepressants.
a-human-right.com

[hollyt2-2009]

Coming from working for a drug company. it all boils down to: buy off the FDA -make promises- distribute the drugs- then RECALL. OOOPS theres a problem.SIDE Effects. but HEY we alresdy made our $$$$$$$$$$$$$'s Thank-you very much

[booyaw_77]

Knowledge is power! Not military might? And not stubbornness. Get people to the doctor! And stop this madness..

Tyranny is a medical diagnosis. And the doctor's on his way, buddy.

[hypnotoad72]

Surely common sense would also dictate having a proper doctor using both textbook knowledge plus empirical experience and intuition (the latter two are lacking in MANY doctors, which also leads to tort-related lawsuits...) and frequent follow-up appointments in terms of a solution?

Saying "Beware for anyone under age ___" is myopic. To say the very least. Or is it more profitable to say that and then sweep it under the rug? Profits aren't a bad thing, but there is more to life than just profits. That includes keeping people alive for repeat treatments; lose the people and there goes your ability to GET a profit at all.

The truth is in the middle.

[booyaw_77]

Parta the problem with mental illness is our lack of universal healthcare. The more people get a checkup, the more comfortable we'll be admitting our psychological discrepancies. Freedom is not insanity. But a very real.. pragmatic.. practical solution. Provide the entire USA federally funded healthcare in some way. You just gave away a trillion dollars to some.. country that doesn't even want ya. You can SURELY provide a universal healthcare plan being superpower. And provide these people an alternative other than going bonkers.

[booyaw_77]

I took Seroquel and Zyprexa, plus a anti-depressant (can't remember what it was called. Might have been welbutrin). Seroquel.. man. I'd take that stuff? And it was like my heart was gonna stop. Deep deep deep fatigue. Zyprexa was more expensive, but it was like walking around in a white fog all day long.

Yup, what kills me about all this stuff is that most of it is experimental. At least it feels like that. Like you're some.. weird scientist's lab. And then there's the tremendous stigma of being medicated. You could do a whole buncha good just trying to repel that stigma.

[samthetvcat]

PS In case this wasn't clear below, the 18% increase in suicides coincided with the 20% drop in use of antidepressants that occurred as a result of the old warning label that only said antidepressants caused suicide, and not also that they helped. 'Common sense' at work - wtg

(http://abcnews.go.com/Health/Depression/story?id=2850783&page=1)

[samthetvcat]

Well that's great to see that they've added that the untreated depression itself poses a greater risk of suicide than the medication and that they're addressing the issue.

Thanks in part to a tide of public sentiment thinking along the lines that Tom Cruise was actually the voice of 'reason' and 'common sense' with regards to Brooke Shields and her use of anti-depressants, the old warning labels that only warned of the increased risk of suicide for teens actually caused suicide rates to rise by 18%.

[drinuk]

Bit late this warning, why did'nt the FDA know about these side effects before approving this poison. Is there a change coming about at the FDA or are they simply trying to pull the wool over the eyes of the American people, I doubt if they care for the people who pay their salaries as much as they do for Big Pharma, sounds like a Snow Job to me.