Thursday, June 2, 2011

Pro-Con: Off-Label Anti-Psychotic Drugs for the Demented Elderly

Here's the pro-con debate from CNN:

Daniel Levinson, Inspector General of DHHS, weighs in on their recent report viewing with alarm how many demented elderly are receiving atypical antipsychotic drugs, which Levinsom notes are not approved by the FDA for this use, and can pose serious risks, including a higher death rate. On the other side is Dr. Danny Carlat, whose work has often been noted in this blog.

Dr. Carlat is no slouch when it comes to revealing the misbehavior of the pharmaceutical industry and of physicians who do its bidding (for just one example, see So it's significant that in this debate, he goes toe to toe with OIG-DHHS and defends the use of these drugs.

Dr. Carlat makes a number of good points. He stresses, as I have tried to myself, that "off-label" does not necessarily equal "wrong use" or "bad use" of a drug. He makes the important point that as of now no drug is approved specifically by the FDA for treatment of agitation caused by dementia, despite the way this condition can make life miserable for both patients and families as well as for staff. Moreover, he notes that several clinical trials support this use of antipsychotic medication. He therefore concludes that it's a matter of individual medical judgment whether for any given patient, the potential harms of these drugs are outweighed by the benefits--and OIG should back off.

Given Dr. Carlat's excellent record I hate to quibble with him, especially in an area where his psychiatric smarts trump any medical knowledge that I possess. But I would pose just one question. The atypical antipsychotics seem to pose one unique risk that especially is worrisome for the elderly--weight gain that could trigger diabetes--that is not shared by the older antipsychotics. And recent literature reviews (see for instance have demonstrated pretty convincingly, I would judge, that there's no real benefit of the newer antipsychotics over the older, to the extent that calling them "second-generation" or "atypical" is probably a serious misnomer. So given that all drug use for this unfortunate problem is going to be off-label anyway, why not use a cheaper, older drug that many primary care physicians understand much better?

1 comment:

Anonymous said...

Disappointingly naive argument from Dr. Carlat, whom I hihgly respect. See my recent letter as it pertains "individual medical judgment" specifically in the context of antipsychotics to the elderly:


BTW, excellent point regarding the "second-generation" and "atypical" being a misnomer. These are little more than marketing terms.