[Info] Congress To FDA: Review Generic Epilepsy Meds

[Cint]

From Pharmalot website:

Congress To FDA: Review Generic Epilepsy Meds
Posted: 17 Nov 2009 04:50 AM PST
Those who take meds to cope with epilepsy will be interested to know that Congress has asked the FDA to examine epileptic drugs the agency considers to be therapeutically equivalent to other products. The disclosure was made in a conference report pertaining to an appropriations bill for the agency.

As the FDA Law Blog posits, the move is presumably related to questions about any “increased risk of seizures or toxic side effects when patients are switched from a brand name to a generic.” The issue has been raised before by the Epilepsy Foundation, the Washington Legal Foundation and a 2008 article in Neurology that changing from a brand to generic may result in seizures.
Pfizer, you may recall, encountered similar concerns last year. That’s when the drugmaker began marketing a new version of its age-old Dilantin med for treating epilepsy. Citing a need to upgrade manufacturing, Pfizer stopped selling Dilantin Kapseals and began selling Dilantin capsules. But some epileptics were complaining that the new product was causing seizures. The agency, meanwhile, is supposedly working on studies to address the problem.

[RCampbell]

I cant take Generic because I end up having break through seizures....only the brand name Tegretol works for me. This is one thing that I worry about....that the GOV takes over health care and decides that the B pill is cheaper than the A pill therefore you have to take the B pill....

Generics of any brand have never worked for me. Docs seem to think it has to do with the fillers in the generic anticonvulsants

[Meetz1064]

understand how you feel, R. I've only found one generic that I can use--Clonazepam. EVERYTHING ELSE HAS to be brand name. Don't ask me why. I have no idea, but if it's not, I'll have breakthroughs, just like you...

[tinasmom]

Cint -

Where did you find this information? I would like to pass this on to our foundation.

[Cint]

Hi Laura,

I found it on this website:
http://www.pharmalot.com/

[IMgood1]

I'm so glad I'm not alone. We found that there is one brand of generic lamotrigine I cannot take. The other generics, and brand name I can. An industry standard would be nice. The breakthrough seizures were very bad. It was quite a shock when they didn't even tell me they had switched brands on me.

[tinasmom]

One problem with these drugs is that they are used for so many other things. It would be so much easier if these were only used for seizures and not other ailments that they don't know how to manage.

[alivenwell]

This scares me worst than any aura I've ever experienced. They'll say it's 'fine' and give us cheaper generics that are 'new and improved'....yeah right!

Why not keep it simple...once a patent expires, allow drug companies to renew the patent and still make the same meds. Their profit has to go down after that expiration.