Friday, November 03, 2006

FDA Drugs: October 2006

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

Just a quick list of relevant FDA and related notices...

Europe approves Chantix: FDA approved this drug in May, but I have yet to see ONE patient on it. This is a unique, anti-smoking drug, so I figure it would be going like gang-busters by now. What's up with that?

Generic Zyprexa: Generic-maker Roxane has received "tentative approval" to make generic olanzapine. This Lilly drug is usually one of the top 3 most costly line-items in each state Medicaid pharmacy budget. The problem with "tentative" approvals is that there remain many hoops for Roxane to jump through, including patent battles, before they can get this to market. Lilly's patent expires in 2011, so it may be a long battle.

Johnson&Johnson has received an approvable letter for their new schizophrenia drug, paliperidone. Unfortunately, it's not much of a new drug. Risperdal (risperidone) get converted to paliperidone in the liver, so the new drug is pretty much the same as the old one. But since Risperdal comes off patent soon, this new drug provides more shelf-life on this product. I figure most will stick with the older, cheaper drug. For more on this, and a great blog I just discovered, go to David E. Williams' Health Business Blog.

First Autism Drug: Janssen (a J&J subsidiary) received a new indication for "irritability associated with autistic disorder" for Risperdal (there are some concerns). That's two firsts. First drug for autism. First drug for "irritability". This really opens up a whole new horizon. It will now be a race to get a drug approved for "agitation associated with dementia". This would be a block-buster!

Severe Alzheimer's Dementia indication approved for Eisai's Aricept (donepezil). It used to be just mild to moderate dementia.

Seroquel for Bipolar Depression: AstraZeneca has received a new indication for "treatment of major depressive episodes associated with bipolar disorder." I think Lamictal is the only other one with this indication (correct me if not).

5 comments:

Dinah said...

Hi Roy. Thanks for doing this. I've seen one patient on Chantix, though he showed up at my office as a new patient totally stressed and was back to smoking.
Seroquel, in those who tolerate it, seems to work for everything. (The Last Psychiatrist would say I like it--)
No updates on the wellbutrin/naltrexone weight loss combo???

Daniel Haszard said...

Eli Lilly 3Q 10% profit rise is nearly all from psyche drugs including zyprexa.How have they schemed to squeeze more money from their zyprexa cash cow when pill production has actually gone down?

ANS-Eli Lilly profiteers have jacked up the price of zyprexa to the federal govt,from the Medicare D payouts.Eli Lilly is a big drug company that puts profits over patients.

They covered up findings that their Zyprexa has a TEN times greater risk of causing type 2 diabetes

Only 9% of Americans trust big pharma,right around the same rating as tobacco companies.

Daniel Haszard Eli Lilly zyprexa drug caused my diabetes www.zyprexa-victims.com

Gerbil said...

I'm glad Zyprexa will someday go generic... I took it for several years at $400+ per month, got pretty curvaceous, and got freaked out when the connection to diabetes was announced (my grandfather had type II, as does my dad, although theirs is the mysterious kind that strikes skinny little dudes), but there was no other option until Abilify came out.

Though I'm back to being a skinny little dudette again and have no need for meds any longer, it pains me to see the financial and physical crap that comes with lots of the meds out there.

(Although I should also note that Eli Lilly is a big funding source for the Presbyterian Church (USA), which would mean little to this secular Jew if not for the source of my partner's paycheck! I have a very conflicted philosophical relationship with Eli Lilly.)

Anonymous said...

I'm on Chantix. I'm gonna go ahead and guess that no one's on it because no one has heard of it yet. I haven't seen a single commercial or print ad, nor a web banner. I went to my OB/GYN last week and discussed quitting smoking while there. She offered Zyban, which I am allergic to. She didn't follow that up with an offer of Chantix, but the next night I went out to dinner with a relative who just went on it, so when I went to my regular doctor a couple days ago, I asked about it. At no point did a medical professional bring it up, and none of the smokers I have talked to about it in the last week or so have heard a thing about it. And I have talked to every smoker in my office building, and some outside of a bar this weekend.

Chaoticidealism said...

Two years later, they are prescribing Risperdal for people just because they have autism, even if there isn't any really bad problem with anger.

Seems doctors just want to prescribe something, to feel like they are doing something. Autism is not something you can manage directly with medication, anyhow; medication tends to be for peripheral things like sleep or anxiety. Autism's the way your brain's made; and there's no medication to change that. You've got to work with it.

I don't like to see young children given this stuff long-term. We don't know what effect it has on learning and neurological development. But it does not seem that many doctors are even considering using it temporarily, if at all, while teaching people to manage their own anger... which I think should be the approach considered long before long-term drug therapy.