Furious Seasons

February 26, 2007

Cymbalta Approved For Anxiety, Harvard Prof Disapproves Of The FDA

Cymbalta, Eli Lilly's blockbuster anti-depressant, was today approved by the FDA as a treatment for Generalized Anxiety Disorder (GAD), the company announced in a press release. The drug is also approved for peripheral neuropathic pain. I cannot wait for the "Where does anxiety hurt?" TV ads. Perhaps it will feature a cat instead of the "Where does depression hurt?" ad's dog.

In other news, Marcia Angell, Harvard Medical School lecturer, has an op-ed in today's Boston Globe banging on the FDA:

"As part of the emphasis on speed, the FDA often approves brand-name drugs on the basis of less evidence than in the past. In these cases, approval may be contingent on companies conducting further safety studies after the drugs are on the market. But the companies usually don't honor that commitment. Of the roughly 1,200 such studies outstanding -- some for years -- over 70 percent haven't been started.
"The FDA is strangely silent about this inexcusable dereliction. When questioned, it weakly protests that it doesn't have the authority to compel the research. In fact, it has enormous leverage, since it can withdraw drugs from the market.

"The FDA also refuses to release unfavorable research results in its possession without the sponsoring company's permission. Here again, it contends not to have the authority to do so, but providing evidence of side-effects or negative results would seem to be an integral part of its job. It's no wonder that serious safety concerns about drugs such as Vioxx, Paxil, and Zyprexa have emerged very late in the day -- years after they were in widespread use."

Yeah, that's kind of a problem.

Posted by Philip Dawdy at February 26, 2007 06:53 AM

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Comments

I think the evidence is pretty solid that Cymbalta is effective for anxiety.

Posted by: Steve at February 26, 2007 08:40 AM

it may be. but the equally important question is what kind of long-term effectiveness the drug will have. the jury is out there. in addition, enough people have had intensely bad reactions to cymbalta to where you just have to scratch your head over the whole thing. speaking of which this here blog is ranked numero uno in a google search for 'cymbalta problems.' and it's not like i have written much about that drug. what that means is that the posts i have done on the drug continue to generate steady hits and get linked elsewhere, which is part of how google measures popularity. a surprise to me, and sort of indicative of questions among the public about the drug.

Posted by: Dawdy at February 26, 2007 09:10 AM

Because of Lilly's expertise in promotion and marketing, their absence in leadership in the creation of novel and NEEDED medicines, and their utter disregard of patient-safety issues, it boggles my mind to understand how they can garner ANY market-share for another of their me-too drugs.

Posted by: Melody at February 26, 2007 09:44 AM

I'm as skeptical of drug companies as the next guy. But some of the criticisms of Cymbalta simply aren't justified. It is not a me too drug. The ratio of 5HT and NE is 1:1 -- that's unique. Yes, people have had bad reactions to it, just like all of the other antidepressants. But that doesn't mean it's a bad drug; we just don't understand depression very well. The real crime of Cybalta, IMHO, is its claim to help the physical symptoms of depression... and these are???

Posted by: Steve at February 26, 2007 03:05 PM

The symptoms of depression are anxiety, agitation, nervousness, sometimes hypomania, psychosis.

Also pain.

Cymbalta is similiar to Effexor in that it is a SNRI.

However, it's as funky or worse.

Duloxetine (Cymbalta) can help for pain related to diabetes.

Any side effects regarding mood changes may have more to do with depression itself like histrionic rages.

Posted by: Steve at March 5, 2007 07:04 AM

So I just found out an acquaintance of mine was put on Cymbalta a couple of months ago for nothing to do with depression at all -- for neuropathic pain or some funky aches in her legs. That's right folks, 60mg of Cymbalta for cramps in her legs, talk about neutron bombs. Anyway after a few weeks she wasn't feeling too hot, not sure of the exact reaction, but her doc said she was having some "extremely rare" reaction and maybe she should come off so they cut her down to 30 mg. for two weeks and then told her to skip days between doses and extend the number of days between each dose because you can't cut Cymbalta -- it's a capsule with pellets inside and, get this, the pellets aren't even all the same size, plus I guess taking the pellets without the capsule coating is kind of like snorting Ritalin instead of swallowing it -- so how are you supposed to get off it? A very well designed drug from the company's point of view. Do you think it might be deliberate? Anyway she's got whooshing and nausea and heaven knows what -- never had any mental illness or mood disorder. Frankly I can't believe this doc is giving her this advice -- doesn't she know anything about half life and the fact that Cymbalta has a very short half life? Therefore stretching out time between big hits is not the way to go. I continue to be astonished at the ignorance out there. I bet when and if she gets those cramps back in her legs they're going to feel pretty good compared to what she's got to look forward to while she continues her effort to get off. Massage therapy might look pretty good.

Posted by: Sara at March 5, 2007 03:00 PM

Sara,
I hope she can successfully remove the Cymbalta; in the meantime, tell her to take a calcium/magnesium supplement. It will stop the leg cramps.

Posted by: Stephany at March 5, 2007 09:09 PM