(Little Evidence To Support) Off-Label Prescription of Atypical Antipsychotics

[HuckleB]

New Insights into Off-Label Prescription of Atypical Antipsychotics
ttp://psychcentral.com/news/2011/09/27/new-insights-into-off-label-prescription-of-atypical-antipsychotics/29841.html

"Physicians and psychiatrists got a wake-up call Tuesday when it comes to prescribing atypical antipsychotics for uses not approved by the U.S. Food and Drug Administration (FDA). A new analysis of previous research suggests the widespread prescription of such medications isn’t indicated for many uses.

For instance, the new research — which included 162 trials with efficacy outcomes and 231 trials or large observational studies with adverse events — found no support for the use of atypical antipsychotic medications for eating disorders or substance abuse.

...

“Atypical antipsychotic medications are approved for marketing and labeling by the U.S. Food and Drug Administration (FDA) for treating schizophrenia, bipolar disorder, and depression under drug-specific circumstances,” according to the researchers.

Alicia Ruelaz Maher, M.D., of RAND Health, and colleagues conducted a systemic review and meta-analysis to examine the efficacy and adverse events associated with off-label use of atypical antipsychotic medications for behavioral symptoms in dementia, anxiety, obsessive-compulsive disorder (OCD), eating disorders, posttraumatic stress disorder (PTSD), insomnia, personality disorders, depression, and substance abuse.

..."


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Sure, there is some evidence, and that's good for people with hard-to-treat conditions, but, well, yeah, I know "everybody already knows this," yet the reality is that such a review is how we actually do know this.

[MannyGoldstein]

1. These drugs have awful side effects. Awful.

I'm not against prescription drugs if they've been demonstrated to be safe and effective for a specific use. But these are nasty drugs that cause horrific metabolic problems. Unless they've been proven relatively safe and effective for a given purpose, they ought never be prescribed.

[laconicsax]

2. This is really interesting.

I'm in an open-label trial of an atypical antipsychotic for MDD, and while the side-effects are annoying, the effect on my MDD has been phenomenal. Of course the information on the study drug beyond what's public isn't available to me, but phase II trials seem to have shown efficacy as an adjunctive treatment.

[HuckleB]

3. MDD does seem to be one diagnosis for which trials are showing benefit.

Good luck. What happens at the end of the trial?

[laconicsax]

4. They haven't told me yet, and I can't find the specific trial info online.

Since it's (most likely) a phase III safety and tolerability study, the drug might be approved for prescription use by the end of the study and participants will be able to pay through the nose for it.

I say most likely because clinicaltrials.gov has a study that matches the description of the one I'm in except for the study number, but the info been updated since May.

The most I know is that come August of next year, I get paid my $75/visit in one lump sum.

[xchrom]

6. wow -- i only got 20 bucks a visit for an experimental cancer treatment once.

good luck to you!

be well!

[laconicsax]

7. The visits are a real pain in the ass...

5-10 pages of questionnaires, 6-7 vials of blood, urine sample, electrocardiogram, brief physical, and a brief psychiatric evaluation over the course of an hour and a half.

[xchrom]

8. well no wonder they pay you more -- mine was

blood and urine only.

[xchrom]

5. recommend