Black Box warning on antidepressants

[mskris]

Breaking news:

The FDA has approved a black box warning label on antidepressant classed drugs. The warning must be posted on pharma websites within 2 weeks and on the products themselves within 30 days.

The black box warning states that "antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders."
"Anyone considering the use of [Insert established name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need," revised labeling states.

"Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior."

Except for products with approved pediatric claims, the black box notes that the drug is not approved for use in pediatric patients.
Lilly's Prozac (fluoxetine) is the only brand with an approved pediatric depression claim, although other brands are approved for conditions like obsessive-compulsive disorder. Anafril and Pfizer's Zoloft (sertraline) are approved for treatment of OCD in pediatric patients.

FDA announced its plans for the black box as part of a public health advisory outlining antidepressant suicidality risk.

In addition to Prozac and Zoloft, Lilly's Cymbalta (duloxetine), Wyeth's Effexor and Forest's Celexa (citalopram) were included in the advisory.

The products affected are as follows:
FDA approved new labeling for GlaxoSmithKline's Paxil (paroxetine), buproprion (Wellbutrin and Zyban) and Parnate (tranylcypromine); Organon's Remeron (mirtazapine); Bristol-Myers Squibb's Serzone (nefazodone); Sanofi-Aventis' Norpramin (desipramine); and Mallinckrodt's Anafril (clomipramine), Pamelor (nortriptyline) and Tofranil-PM (imipramine).

Other approvals were Ranbaxy's Aventyl (nortriptyline), Apothecon's Desyrel (trazodone), Valeant's Limbitrol (chlordiazepoxide/amitriptyline), Oxford's Marplan (isocarboxazid), Synthon's Pexeva (paroxetine), and Odyssey's Surmontil (trimipramine).

This info is from the "Pink Sheet," a reputable pharmaceutical newsletter.

In addition to the black box warning, FDA is requiring Medication Guides as another way to convey information to pediatric patients and their parents ("The Pink Sheet" DAILY, Nov. 4, 2004).

"Although the ultimate goal is to have the Medication Guide attached to unit-of-use packaging, until such packaging becomes available, it is our expectation that you will prepare tear-off pads or provide for some other means of disseminating these standard antidepressant Medication Guides and make such tear-offs or means available to pharmacists and physicians by January 31," the approval letters state.

MsKris

[tridlette]

Kris, thanks for this WARNING!

Do you, or does anyone know, if there is an increased risk for the adult population as well?

It seems to me that Chemistry is Chemistry, and it would have the same potentiality for adults.

Laurie

[sweety]

:)Been on an antidepressant for 8 years. I would be suicidal if I WASN'T on it. Can tell you all about depression both post partum and regular with lots of anxiety thrown in. Antidepressants are a gift from God as far as I am concerned. Am trying everything I can think of to help dd not go through that process. Everyone in my family that had ADHD also fought depression. May be now that dd is medicated for her ADHD and gets lots and lots of positive reinforcement and coping skills, The cycle will end.

[eaccae]

I think that as we grow our chemistry changes - as children it probably flucuates more. I know that with medications like lithium - it works wonders on my dad & uncle but it can cause central nervous sytem damage under the age of 11.

I don't think medications always work the same in children as in adults. Otherwise this warning wouldn't be mandatory.

I think the FDA is JUST starting to realize this and realize that with many medications - there have been very little - to no studies done on pediatric usage.

Hopefully this is a wake up call to get more studies underway.

[mskris]

eaccae is right. Chemistry is NOT chemistry when talking adults vs. children. Pediatrics is much different in many instances. That is why a few years ago, FDA created a mandate for testing in pediatric populations. THey offered 3 extra years of patent exclusivity if a product was studied and approved in peds patients.

Those products approved for adult use have already gone through extensive safety testing - especially for psych drugs that may cause other psych symptoms. Also, there is post-marketing surveillance of all drugs and if an issue comes up after approval that was not previously seen (eg, vioxx), it can be withdrawn or further warnings/precautions added to the labeling.

The problem is that though many drugs are not approved in peds populations, there is no law against a physician writing a scrip "off-label." That's why many drugs are used for conditions in which they weren't approved (eg, use of antipsychotics for autism, chemo drugs for other types of cancers, etc.). Sometimes that's a good thing, sometimes not. In the case of these antidepressants, use in peds populations was not studied nor approved, and it was only through clinical "off-label" use that this effect was documented.

Kris

[AnneM]

This black box in ITSELF (IMO) could cause more damage in the 'bigger' picture than remaining with no label at all .... to me the "black box" is in effect a " Disclaimer" ... ii.e. what it is really saying is : IF this should happen to you (extremely small percentage) then don't say we didn't warn you!!

But hang on ... what about the larger percentage of young people who truly benefit from antidepressants ... I bet many of THEM will not take them in the future because of the words on that black box .... and THAT could be VERY sad because there are a huge amount of kids who can genuinely HUGELY benefit from antidepressants - in fact antidepressants can literally turn their lives around for the absolute BETTER!!

[eaccae]

I think it a good thing. It is sending a message to the drug companies that they better do pediatric studies. It is sending a message to doctors to hopefully stop and think about what meds they are prescribing and why. And it is hopefully giving information to parents a real warning so that they ARE informed of some of the risks and whether they feel they need to proceed or perhaps if there are alternatives. Knowing this info - I, personally, would want to try prozac first. I am no stranger to depression and am someone who almost succeeded in killing themselves at the age of 13 once and 17 twice. My father and my uncle are bipolar. I still believe this is a good thing!!! There are a lot of parents out there that put too much trust in their doctors and don't research as much as most of us on this board have. There are a lot of doctors that put too much trust or get kickbacks from the drug companies and are prescribing medication without always fully knowing all the risks - even if they are doctors. Hopefully there wil be more research because of this and better options can be found for our children.

[AnneM]

Elizabeth ... I have to say that although our opinions differ somewhat ... What you say here is excellent ... and now I personally am torn right down the middle!! ...
Good or bad? I can now see a point of view from "both angles" ...

[camismom]

I guess I have to join Anne in being torn down the middle on this one. I agree that it may scare those that could truly benefit from using it, but I also agree that for those who put too much trust into their doctors without doing research of their own, this needs to be there. It is indeed a fine line. I know personally I would research anything given to Cami fopr depression because she is already on another presc med. Thankfully though the counselor she is seeing said although "some depression is visible, I believe we can get her through it without use of presc. meds". That was good to hear...