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Re: Generic Zyprexa. Day one » SLS

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
Abstract

OBJECTIVE:
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


Some see things as they are and ask why.
I dream of things that never were and ask why not.

- George Bernard Shaw

 

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