![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 51 to 75 of 75. Go back in thread:
Posted by SLS on November 19, 2011, at 17:15:38
In reply to Re: Generic Zyprexa. Day one, posted by ed_uk2010 on November 19, 2011, at 17:09:51
> >It is not my job to ascertain why I reacted poorly to Mylan. I just know that I did.
>
> You did, and there could be a hundred and one reasons why you felt bad at that time, one of which is due to the change in medication.I'm glad that you finally came around to conclude that the change in medication is one possible reason for my deterioration upon the switch to the generic preparation. That is realistic.
- Scott
Posted by ed_uk2010 on November 19, 2011, at 17:25:00
In reply to Re: Generic Zyprexa. Day one » ed_uk2010, posted by SLS on November 19, 2011, at 17:15:38
I should never have started posting here again. People do not get well on this board, it just perpetuates illness. Everyone looking for the ultimate combo which does not exist.
Posted by SLS on November 19, 2011, at 17:26:51
In reply to Re: Generic Zyprexa. Day one, posted by ed_uk2010 on November 19, 2011, at 17:25:00
> I should never have started posting here again. People do not get well on this board, it just perpetuates illness. Everyone looking for the ultimate combo which does not exist.
Whatever rocks your boat.
- Scott
--------------------------------------
ArticlesGeneric antiepileptic drugs and associated medical resource utilization in the United States
D.M. Labiner, MD,
P.E. Paradis, MA, DESS,
R. Manjunath, MSPH,
M.S. Duh, MPH, ScD,
M.-H. Lafeuille, MA,
D. Latrémouille-Viau, MA,
P. Lefebvre, MA and
S.L. Helmers, MD+ Author Affiliations
From the Departments of Neurology and Pharmacy Practice and Science (D.M.L.), University of Arizona, Tucson; Groupe d'analyse, Ltée (P.E.P., M.-H.L., D.L.-V., P.L.), Montréal, Québec, Canada; GlaxoSmithKline (R.M.), Research Triangle Park, NC; Analysis Group, Inc. (M.S.D.), Boston, MA; and Department of Neurology (S.L.H.), Emory University, Atlanta, GA.
Address correspondence and reprint requests to Dr. David M. Labiner, The University of Arizona, Department of Neurology, 1501 N Campbell Ave., Tucson, AZ 85724 labinerd@u.arizona.edu
Abstract
Objective: To evaluate whether generic substitution was associated with any difference in medical resource utilization for 5 widely used antiepileptic drugs (AEDs) in the United States.
Methods: Health insurance claims from PharMetrics Database, representing over 90 health plans between January 2000 and October 2007, were analyzed. Adult patients with epilepsy, continuously treated with carbamazepine, gabapentin, phenytoin, primidone, or zonisamide, were selected. An open-cohort design was used to classify patients into mutually exclusive periods of brand vs generic use of AEDs. Pharmacy and medical utilization were compared between the 2 periods with multivariate regression analyses. Results were stratified into epilepsy-related medical services, and stable (≤2 outpatient visits per year and no emergency room visit) vs unstable epilepsy. Time-to-event analyses were also performed for all services and epilepsy-related endpoints.
Results: A total of 18,125 patients were observed in the stable group and 15,500 patients in the unstable group. After adjustment of covariates, periods of generic AED treatment were associated with increased use of all prescription drugs (incidence rate ratio [IRR] [95% confidence interval (CI)] = 1.13 [1.131.14]) and higher epilepsy-related medical utilization rates (hospitalizations: IRR [95% CI] = 1.24 [1.191.30]; outpatient visits: IRR [95% CI] = 1.14 [1.131.16]; lengths of hospital stays: IRR [95% CI] = 1.29 [1.271.32]). Generic-use periods were associated with increased utilization rates in stable and unstable patients and with 20% increased risk of injury, compared to periods with brand use of AEDs.
Conclusions: Generic antiepileptic drug use was associated with significantly greater medical utilization and risk of epilepsy-related medical events, compared to brand use. This relationship was observed even in patients characterized as stable.
AED = antiepileptic drug; CI = confidence interval; ER = emergency room; HR = hazard ratio; ICD = International Classification of Diseases; IRR = incidence rate ratio.
Posted by ed_uk2010 on November 19, 2011, at 17:32:16
In reply to Re: Generic Zyprexa. Day one » ed_uk2010, posted by SLS on November 19, 2011, at 17:15:38
Good luck.
Posted by SLS on November 19, 2011, at 17:35:16
In reply to Re: Generic Zyprexa. Day one, posted by ed_uk2010 on November 19, 2011, at 17:32:16
> Good luck.
Don't need any.
- Scott
Posted by ed_uk2010 on November 19, 2011, at 17:35:58
In reply to Re: Generic Zyprexa. Day one » ed_uk2010, posted by SLS on November 19, 2011, at 17:35:16
> > Good luck.
>
> Don't need any.
>
>
> - ScottI guess you need a miracle then.
Posted by ed_uk2010 on November 19, 2011, at 17:54:45
In reply to Re: Generic Zyprexa. Day one, posted by ed_uk2010 on November 19, 2011, at 17:35:58
I'm gone now.
Posted by Phillipa on November 19, 2011, at 18:58:48
In reply to Re: Generic Zyprexa. Day one, posted by ed_uk2010 on November 19, 2011, at 16:52:03
That's what greenstone is also as told to me by a pharmacist when I was buying brand he explained to me. PJ
Posted by sigismund on November 19, 2011, at 19:45:04
In reply to Re: Generic Zyprexa. Day one, posted by ed_uk2010 on November 19, 2011, at 17:25:00
>I should never have started posting here again.
It's always a real pleasure to see you here.
>People do not get well on this board, it just perpetuates illness.
Maybe so.
>Everyone looking for the ultimate combo which does not exist.
Not here and now for sure.
Posted by Phillipa on November 19, 2011, at 20:55:06
In reply to Re: Generic Zyprexa. Day one » ed_uk2010, posted by sigismund on November 19, 2011, at 19:45:04
Hi Sigi what's up? PJ
Posted by ed_uk2010 on November 19, 2011, at 23:43:14
In reply to Re: Generic Zyprexa. Day one, posted by ed_uk2010 on November 19, 2011, at 17:04:31
Guys, I'm sorry. I've been really unpleasant. I am not feeling very good at all. Sorry.
Posted by ed_uk2010 on November 19, 2011, at 23:45:29
In reply to Re: Generic Zyprexa. Day one » ed_uk2010, posted by Phillipa on November 19, 2011, at 18:58:48
> That's what greenstone is also as told to me by a pharmacist when I was buying brand he explained to me. PJ
Oh I get it, but I don't think it would be a good idea to say anymore about it.
Posted by ed_uk2010 on November 19, 2011, at 23:47:29
In reply to Generic Zyprexa. Day one, posted by Zyprexa on November 19, 2011, at 6:34:29
> So I took the first 10mg teva olanzapine. And feeling very positive about it. Not a huge difference.
Please will you start a new thread to report your experience. This one went wrong!
Posted by ed_uk2010 on November 19, 2011, at 23:48:39
In reply to Re: Generic Zyprexa. Day one » ed_uk2010, posted by sigismund on November 19, 2011, at 19:45:04
> >I should never have started posting here again.
>
> It's always a real pleasure to see you here.Thanks Sigi. It's really nice to see you too.
Posted by ed_uk2010 on November 19, 2011, at 23:50:01
In reply to Re: Generic Zyprexa. Day one, posted by ed_uk2010 on November 19, 2011, at 17:35:58
>a miracle then.
>I didn't mean that at all. I'm down and it's making me irritable. Sorry.
Posted by Phillipa on November 20, 2011, at 0:10:38
In reply to Re: Generic Zyprexa. Day one, posted by ed_uk2010 on November 19, 2011, at 23:50:01
Ed it's okay. Everyone has bad days. Love PJxxxx
Posted by ed_uk2010 on November 20, 2011, at 5:24:07
In reply to Re: Generic Zyprexa. Day one » ed_uk2010, posted by Phillipa on November 20, 2011, at 0:10:38
> Ed it's okay. Everyone has bad days. Love PJxxxx
Thanks PJ. It was certainly a bad day. I don't like to hurt people's feelings.
Posted by jono_in_adelaide on November 20, 2011, at 16:42:31
In reply to Re: Generic Zyprexa. Day one » Phillipa, posted by ed_uk2010 on November 20, 2011, at 5:24:07
I often think way too much is made of the brand vs generic issue, before generics are released they have to show bioequivelence, that is, not only contain the same amount of drug as the original, but show serum levers etc that are virtualy the same. 30 years ago they didnt, and problems werent uncommon, but there have been a lot of changes since then.
Posted by SLS on November 21, 2011, at 5:39:46
In reply to Re: Generic Zyprexa. Day one, posted by jono_in_adelaide on November 20, 2011, at 16:42:31
> I often think way too much is made of the brand vs generic issue
It only takes one bad drug to become an issue if you are the one taking it.
> before generics are released they have to show bioequivelence
No. In the US, there is a 20% range of difference which a generic drug is allowed to deviate from the original product with respect to absorption. There is nothing "equivalent" about a 20% difference.
> that is, not only contain the same amount of drug as the original, but show serum levers etc that are virtualy the same.
For some drugs and for some people "virtually" is not good enough.
I don't know why this is a big issue either.
- Scott
Posted by SLS on November 21, 2011, at 5:42:52
In reply to Re: Generic Zyprexa. Day one, posted by SLS on November 21, 2011, at 5:39:46
> > I often think way too much is made of the brand vs generic issue
>
> It only takes one bad drug to become an issue if you are the one taking it.
>
> > before generics are released they have to show bioequivelence
>
> No. In the US, there is a 20% range of difference which a generic drug is allowed to deviate from the original product with respect to absorption. There is nothing "equivalent" about a 20% difference.
>
> > that is, not only contain the same amount of drug as the original, but show serum levers etc that are virtualy the same.
>
> For some drugs and for some people "virtually" is not good enough.
>
> I don't know why this is a big issue either.
I take two generic drugs, by the way. I am sure that the majority of generic products are clinically as effective as the original branded product.
- Scott
Posted by SLS on November 22, 2011, at 7:09:53
In reply to Re: Generic Zyprexa. Day one, posted by SLS on November 21, 2011, at 5:39:46
> > I often think way too much is made of the brand vs generic issue
> It only takes one bad drug to become an issue if you are the one taking it.
> > before generics are released they have to show bioequivelence
> No. In the US, there is a 20% range of difference which a generic drug is allowed to deviate from the original product with respect to absorption. There is nothing "equivalent" about a 20% difference.
> > that is, not only contain the same amount of drug as the original, but show serum levers etc that are virtualy the same.
> For some drugs and for some people "virtually" is not good enough.> I don't know why this is a big issue either.
I may have already posted the following link, but I can't find it in the thread. I apologize for any redundancy. Here is the abstract to a pertinent study:
- Scott
--------------------------------------
http://www.ncbi.nlm.nih.gov/pubmed?term=18695164
Neurology. 2008 Aug 12;71(7):525-30.Generic substitution in the treatment of epilepsy: case evidence of breakthrough seizures.
Berg MJ, Gross RA, Tomaszewski KJ, Zingaro WM, Haskins LS.
Source
Strong Epilepsy Center, University of Rochester Medical Center, Rochester, NY 14642-8673, USA. Michel_Berg@URMC.Rochester.edu
AbstractOBJECTIVE:
There are concerns that generic and brand antiepileptic drugs (AEDs) may not be therapeutically equivalent. This study investigated how generic AED substitution may have negative consequences.METHODS:
Sixty-nine of 150 physicians who participated in a large survey on generic AED substitution completed a case review form regarding a patient who experienced a loss of seizure control due to a generic AED. Nineteen were excluded from analysis.RESULTS:
Fifty patients, well-controlled on a brand AED, subsequently experienced a breakthrough seizure or increased seizure frequency after switching to a generic without other provoking factors. AEDs included phenytoin (15 cases), valproic acid (14), carbamazepine (7), gabapentin (8), and zonisamide (8). Two patients were on a combination of two AEDs, both of which were switched to generics. In 26 cases serum AED levels were known both before and after generic substitution. Twenty-one had lower levels at the time of the breakthrough seizure on the generic medication. Loss of seizure control had a negative impact on quality of life, including loss of driving privileges (n = 30) and missed school/work days (n = 9).CONCLUSIONS:
Changing from a brand antiepileptic drug (AED) to a generic may result in seizures. This raises the concern that current Food and Drug therapeutic equivalence testing regulations may not be adequate for AEDs and suggests that more clinical evidence is needed. Physicians, pharmacists, patients, and policy makers should be aware that for some patients there may be risks associated with switching from brand to generic AEDs.PMID:
18695164
Posted by jono_in_adelaide on November 22, 2011, at 17:17:04
In reply to Re: Generic Zyprexa. Day one » SLS, posted by SLS on November 22, 2011, at 7:09:53
I think the publicity given to this issue just gives hypochondriacs one more thing to obsess over.
The 20% difference allowed in serul levels is within the range of normal distribution seen with the original brand amoung different users - so in effect, it is equivalent.
Some drugs with a narrow theraputic window arnt bioequivalent (thyroid hormone, warfarin etc) and pharmacists know not to interchange then, but Zoloft and Valium and Zyprexia dont fall into this class.
Saying "I took a generic Zyprexia last night and today I feel like sh*t, it must be the generic" is like saying "last night I had a lamb chop for diner, and today I feel like sh*t, it must be the lamb chop making me anxious/depressed/paranoid" - it is more likely to be coincidence, we all have good days and bad days
Posted by SLS on November 22, 2011, at 17:50:24
In reply to Re: Generic Zyprexa. Day one, posted by jono_in_adelaide on November 22, 2011, at 17:17:04
This is what I said:
http://www.dr-bob.org/babble/20111110/msgs/1003071.html
That's all.
- Scott
Posted by SLS on November 23, 2011, at 6:10:59
In reply to Re: Generic Zyprexa. Day one, posted by jono_in_adelaide on November 22, 2011, at 17:17:04
Hi.
A few more things.
> I think the publicity given to this issue just gives hypochondriacs one more thing to obsess over.
That some people are hypochondriacs or obsessive should not be a determinant in making policy for establishing medical facts.
> The 20% difference allowed in serul levels is within the range of normal distribution seen with the original brand amoung different users
I am curious where I might find more information about this. Would you point me in the right direction?
> - so in effect, it is equivalent.
Or perhaps off by 40% for some people, no?
I don't think things are quite this simple. I guess it depends on the details involved in the testing of drugs. That's why I would like to see some material regarding generic drug testing and FDA regulations.
- Scott
Posted by SLS on November 23, 2011, at 6:30:23
In reply to Re: Generic Zyprexa. Day one » jono_in_adelaide, posted by SLS on November 23, 2011, at 6:10:59
> Or perhaps off by 40% for some people, no?
I guess that was too much of a reach. Sorry.
- Scott
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.