Furious Seasons

January 07, 2008

Time For Testimony on Zyprexa Injectable

Many of you know that the FDA's psychopharmacologic drugs advisory committee is set to hold a hearing on Lilly's pending application for its two-week to four-week injection of Zyprexa on Feb. 6. The deadline for public testimony that the advisory committee must consider is Jan. 10 for oral testimony and Jan. 18 for written testimony. Lilly is seeking approval for the drug's use in schizophrenia where you can bet the company will make a big marketing push to steer doctors to use it instead of the commonly-used (and off-patent) Haldol.

The hearing will be held in Silver Spring, MD. It is important that people let the committee know their thoughts on this drug. What I gather from some press coverage and general talk is that the committee is only concerned about somnolence caused by the drug. I haven't seen results from clinical trials for this formulation of Zyprexa, but knowing Lilly's pattern I'd expect that the trials were of fairly short duration, perhaps four weeks. It's kind of hard for side effects of this drug to show up in four weeks, aside from somnolence which would be there from the get-go.

You can sign up to testify or submit written testimony to the FDA at: diem.ngo@fda.hhs.gov.

I hope people who submit written comments and testify make note of Zyprexa's well-known safety problems, particualrly in long-term use. This new injectable (there's actually a shorter-acting one already on the market) would almost exclusively be used in patients for the long-term (i.e., well beyond the scope of clinical trials) who've been deemed non-compliant with treatment much as Haldol injections, and to a lesser degree Risperdal Consta, are used today.

I know the FDA is largely restricted to approving a drug based upon clinical trials data for basic efficacy and safety, but this time out I think they need to think outside their usual limits and ask some difficult questions about how this drug would be used and whether Lilly has any long-term data on its safety and efficacy in, say, one-year-long trials. If Lilly cannot offer long-term data, I hope the committee recommends that the FDA proper not approve the drug absent long-term data.

That strikes me as the only fair way to approach this situation.

Posted by Philip Dawdy at January 7, 2008 12:01 AM

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Comments

I read that this two week shot was to be used for ¨people who were noncompliant about taking their daily pill. To me it smacked of forced drugging, let along the concern that whatever clinical trial was done by Lilly was probably as feeble as the one done to prove zyprexa was safe for children. Let alone the initial clinical trial. I´ve read articles from ER doctors that have said injectable Zyprexa, meant to calm someone in acute crisis , were dangerous, and that deaths had been caused. In my view, the entire drug should be taken off the market, but this one sure looks like a definite NO.

Posted by: Sorrowful at January 8, 2008 10:44 AM

I was recently in the hospital for toxic Lithium levels (lotsa fun - you get to puke, stutter and talk funny - not to mention the wonderful body tremors.) I'm bipolar I. I've always been compliant with my medications, even the ones prescribed by my old pdoc - she had me on so much medications that my coworkers thought I was a zombie and they recommended me taking time off (under short term disability) to get them worked out.

None of the APs worked for me - Seroquil, Risperdal, Invega - you name it - they all created bad side effects in me.

It wasn't until I was started on Zyprexa in the hospital that I began to feel "normal" and balanced again. It's the only medication that has worked for me. I started at 10 mg, but when I felt like I was getting a little manic, my new pdoc upped the dose to 15 mg.

I'm so grateful for Zyprexa - I'm back to work and my family life is so much better (when mama's happy - everyone's happy!)

I don't know anything about the Zyprexa injection, but I figure I wouldn't take it because the oral medication works fine for me.

I looked at my insurance information that came with my script. A month worth of Zyprexa was $677 - fortunately I only pay my $35 deductible. I worry about all the folks out there that don't have insurance. Would this injectable med be used at mental health clinics perhaps to help those who fall through the cracks?

Of course, if it causes more deaths then it shouldn't be approved. More work obviously needs to be done on the formula.

All I know is my personal experience with Zyprexa. It's working and I'm so, so grateful.

Posted by: Angela at January 14, 2008 07:19 AM

Diagnosed manic in 2005, i hve used zyprexa 2 years.
The most prominent effects were :
-lost ability of complex abstract thoughts
-gain of 60 lbs weight in 7 months ( from fit to fat)
-sleeping 12 to 14 hours instead of 7 or 8
-loss of interest for old favourite habits
-gigantic appetite
-loss of intellect
-Impotence
-lethargia
-depression
-alcoholism
-all this combined with a never ceasing feeling of restlessness deepest within

Permanent problems seem to remain , like
-slight loss of intellectual capabilities
-enhanced reaction to sounds
-temporary impotence and slight ;loss of erection
-feet problems arisen from suddenly gained weight.

Zyprexa didnt help , and was combined with (european) names :
-oxazepam
-citalopram
-fenegan

thats how effective the zyprexa was.

Posted by: Simon Wegel at January 17, 2008 05:21 PM