More psych meds under attack

[Anasazi23]

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Now the methylphenidates will likely get black boxes too.

Makes our job that much harder.

Feel free to discuss the comparative liability of psychiatrists, malpractice premiums, personal experiences with adverse effects of the methylphenidates, etc.

While I'm not in support of over-medicating children in the absence of discipline, it appears the FDA made some big reactionary mistakes with the SSRI/suicide phenomena. Most of the new data doesn't support the findings.

In fact, the new American Journal article showed in a sample size of over 65,000 with over 82,000 episodes of antidepressant treatment showed the highest suicide risk to be the month before SSRI treatment.
(Am J Psychiatry 163:41-47, January 2006)

The quick-draw reactions of the FDA are supported by these types of characters:

Dr. Steve Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, told fellow committee members they should recommend the black box warning.
Nissen said his suggestion was meant partly to slow what he characterized as the "out-of-control growth" in use of the drugs.

🙄

 

[16846]

It's all very silly. Of course stimulants are going to carry some cardiovascular risk, any mixed non-specific alpha/beta agonist does. That's something every 1st year med. student should know.

They should just make it standard that anyone being put on significant doses of stimulants first gets a full cardiovascular examination to rule out the possibility of underlying pathology that would be aggravated by the medication.

Doesn’t that sound prudent and appropriate to everyone else?

 

[OldPsychDoc]

It's all very silly. Of course stimulants are going to carry some cardiovascular risk, any mixed non-specific alpha/beta agonist does. That's something every 1st year med. student should know.

They should just make it standard that anyone being put on significant doses of stimulants first gets a full cardiovascular examination to rule out the possibility of underlying pathology that would be aggravated by the medication.

Doesn’t that sound prudent and appropriate to everyone else?

So, what's a "full cardiovascular examination"? EKG, echo? Shall we "prudently" order these on all of the gazillion kids on "significant doses of stimulants"? Right now it already takes kids in our system 4-6 weeks to get an appointment with a prescriber...shall we send them away from these appointments with another 4 week work-up, or just insist that they have it all done before we see them in the first place.

Just wondering...

 

[Anasazi23]

Now it'll take even longer to get an appointment with a psychiatrist, since a significant portion of stimulants are prescribed by peds, family docs, and especially neurologists. If this is the way that they want it (black box), then for sure most of the peds and family docs will stop prescribing these, and probably a good portion of the neurologists too. That will make appointments with psychiatrists harder to get. We've seen that already with the drop in SSRIs to adolescents (can't remember where I saw the data).

I agree with eponym. You want a black box? We want at least a transthoracic echo and an ekg.

ADHD isn't a life-threatening condition. If it takes another 2 weeks to get the echo and ekg done (shouldn't take that long anyway), so be it.

 

[Doc Samson]

You guys see the article on SSRIs in pregnancy increasing risk for persistent pulmonary hypertension of the newborn in this issue of NEJM?

http://content.nejm.org/cgi/content/abstract/354/6/579

I haven't been blown away by the studies of adverse effects of SSRI in pregnancy (even the criteria for discontinuation syndrome in the newborn seemed soft), but these numbers look worrying. Thoughts?

 

[nortomaso]

You guys see the article on SSRIs in pregnancy increasing risk for persistent pulmonary hypertension of the newborn in this issue of NEJM?

http://content.nejm.org/cgi/content/abstract/354/6/579

I haven't been blown away by the studies of adverse effects of SSRI in pregnancy (even the criteria for discontinuation syndrome in the newborn seemed soft), but these numbers look worrying. Thoughts?

The study reports an incidence of PPHN of 1/100 in women taking SSRI's versus 2/1000 in unexposed. Anyone one know what is the incidence of serious newborn complications (minus the risk in nondepressed) of untreated depression in pregnant women? Greater or less than 1/100?

 

[Poety]

The study reports an incidence of PPHN of 1/100 in women taking SSRI's versus 2/1000 in unexposed. Anyone one know what is the incidence of serious newborn complications (minus the risk in nondepressed) of untreated depression in pregnant women? Greater or less than 1/100?

This article is interesting, however I think limited. It didn't say what the outcomes were (well, ok, I couldn't access them!) of the newborns with PPHTN. From the research I did on this subject, it seemed most newborns with adverse side effects had resolved within the first 6 months. Also, it was dependant on how close to delivery the mother had taken the meds, which suggested that tapering mom near delivery and restarting after birth would be most efficacious and safe for the baby.

I think that women with depression that become pregnant really should seek out close followup with a psychiatrist to evaluate how she is progressing and determine whether or not potential for PPD is increased as well as increasing depression (hormone/endocrine induced or exacerbated). Most OB's are going to agree that seeing a psych is a good idea in someone with treatment resistant or med requiring depression.

There is also a scale that they've been using - the Edinburgh scale to evaluate PPD and need for closer follow up. Risk vs. benefit is always an issue in this patient population.

 

[Doc Samson]

This article is interesting, however I think limited. It didn't say what the outcomes were (well, ok, I couldn't access them!) of the newborns with PPHTN. From the research I did on this subject, it seemed most newborns with adverse side effects had resolved within the first 6 months. Also, it was dependant on how close to delivery the mother had taken the meds, which suggested that tapering mom near delivery and restarting after birth would be most efficacious and safe for the baby.

I think that women with depression that become pregnant really should seek out close followup with a psychiatrist to evaluate how she is progressing and determine whether or not potential for PPD is increased as well as increasing depression (hormone/endocrine induced or exacerbated). Most OB's are going to agree that seeing a psych is a good idea in someone with treatment resistant or med requiring depression.

There is also a scale that they've been using - the Edinburgh scale to evaluate PPD and need for closer follow up. Risk vs. benefit is always an issue in this patient population.

From a commentary in the same issue of NEJM (Mills JL. Depressing Observations on the Use of Selective Serotonin-Reuptake Inhibitors during Pregnancy. N Engl J Med. 2006 Feb 9;354(6):636-8).


"In one study involving 155 full-term newborns with moderately severe PPHN, 11 died, and nearly half the survivors had serious sequelae including cognitive delay, major neurologic abnormalities, and hearing loss."

I don't think anyone's suggesting that we shouldn't use SSRIs during pregnancy, but we'd better think about including PPHN in our informed consent. Hope this won't hurt out malpractice rates. 😕

 

[Anasazi23]

Managing the pregnant psychiatric patient is tricky. It's easy to see how the OB/GYN rates have skyrocketed. The more studies, the more will be found. This will gradually increase so that by the year 2100, all medications will have some adverse effect on the mother or newborn.

I now have lodged into my motor memory, "risks and benefits of above treatment discussed with patient."

 

[Poety]

From a commentary in the same issue of NEJM (Mills JL. Depressing Observations on the Use of Selective Serotonin-Reuptake Inhibitors during Pregnancy. N Engl J Med. 2006 Feb 9;354(6):636-8).


"In one study involving 155 full-term newborns with moderately severe PPHN, 11 died, and nearly half the survivors had serious sequelae including cognitive delay, major neurologic abnormalities, and hearing loss."

I don't think anyone's suggesting that we shouldn't use SSRIs during pregnancy, but we'd better think about including PPHN in our informed consent. Hope this won't hurt out malpractice rates. 😕

Thanks Doc, and excellent reference - I am wondering though if this was the only aspect that could have effected the newborns. I do however think they're very tricky as Sazi said - when I have more time I'll look at that reference.

Great thread Sazi!