FDA Drugs: December 2006

2007: Mar | Feb | Jan . . . 2006: Dec | Nov | Oct | Sep

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I'm a bit behind on listing relevant FDA update info, so I'll get you all up to date.

• Zyprexa (olanzapine) labeling change: Label was revised to state that "Rare postmarketing reports of hepatitis have been received. Very rare cases of cholestatic or mixed liver injury have also been reported in the postmarketing period." [.pdf]
• Bifeprunox for Schizophrenia: Phase III results were released showing that patients did better on this than on placebo over 6 months (not hard to beat placebo). They also reported weight and lipid profile reductions. Their New Drug Application was submitted to the FDA in October.
• Invega (iloperidone) results: These results are interesting in that they looked at efficacy and side effects data stratified by whether or not one had a particular pharmacogenetic genotype. They do not identify the genotype, but I suspect it is something like DRD4 or DAT-1. So far, however, we have yet to see the promise of a pharmacogenetic test which one would perform prior to prescribing a drug. For this to really work, the test will have to be free and the results available promptly.
• Melt-in-your-mouth Methadone: Roxane got a dissolvable 40mg methadone approved.
• Invega (iloperidone) approved: This is an active metabolite of Risperdal/risperidone, very similar to this atypical antipsychotic. [label] [detailed review]
  

Say What???

OK, I'm not one to care about celebrity gossip and that's not the point of this post. I just saw this on CNN and it just struck me how far we still have to go about educating the general public about psychiatric issues. It would help if the media at least would get it right.

Here's a quote from the CNN coverage of Anna Nicole Smith's autopsy findings:

His death was ruled an accidental overdose of three antidepressant medications: methadone, Lexapro and Zoloft, according to forensic pathologist Cyril Wecht, who performed a private autopsy at the request of his mother.

Ouch. When did methadone become an antidepressant? And how will P4P reimburse for that?

Double Poppycock

Dr. Eliot Gelwan blogs about British psychiatrist Dalrymple's musings ("Poppycock") that the dramatic and gut-wrenching symptoms which accompany narcotic withdrawal are induced by the presence of a sympathetic (and script-wielding) individual, and that the nature of addiction is essentially based on one's character defects (now there's an original thought).

Says Dalrymple:

I have witnessed thousands of addicts withdraw; and, notwithstanding the histrionic displays of suffering, provoked by the presence of someone in a position to prescribe substitute opiates, and which cease when that person is no longer present, I have never had any reason to fear for their safety from the effects of withdrawal.

Gelwan wisely concludes:

I largely agree that withdrawal from opiates is highly overrated, and that addicts have a hard time being honest with those of us to whom they come for assistance. However, ... the fact that Dalrymple works in the penal system ... is probably what stops him from being more compassionate toward these unfortunate individuals who have so little in the way of coping mechanisms... .

Both psychiatrists correctly point out that narcotic withdrawal generally won't kill you, but alcohol or sedative withdrawal may. However, to contradict Dr. Dalrymple (I love how that sounds), I am certain there are a number of lab animals which would clearly demonstrate withdrawal symptoms, whether or not in the presence of a nice scientist with a syringe full of relief.
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Clink: He's got your (support) goat!