Coping With Epilepsy Denver Neurofeedback
10% off neurofeedback training for CWE members - Denver, CO
Neurofeedback Partner - Free Advertisement
 

Go Back   Epilepsy Forum > Peer Support > The Library



Reply
 
LinkBack Thread Tools
  #1  
Old 12-14-2013, 10:17 PM
Endless's Avatar
Super Moderator / Even Keel
 
Join Date: Feb 2010
Location: U.S.
Posts: 4,466
Thanks: 821
Thanked 1,234 Times in 954 Posts
Send a message via AIM to Endless

Generic Drugs and "Bioequivalence"


Breakthrough seizures with generic drugs or changes in manufacturers is a huge issue for some. Did you see this link in the Epilepsy News section? The Epilepsy Community (I don't know exactly who that is) is asking the FDA to redefine bioequivalence from the current standard of 80% to 120% to a stricter standard. Hopefully, fewer breakthrough seizures due to manufacturer changes. I think it would be a good move for other drugs as well.

http://www.sciencedaily.com/releases...1209104920.htm

Quote :
Epilepsy Community Seeks Redefinition of Bioequivalence from FDA
Quote :

Dec. 9, 2013 — For several years, epilepsy practitioners have questioned the U.S. Food and Drug Administration's (FDA) definition of bioequivalence as it applies to narrow therapeutic index (NTI) drugs, such as those used for epilepsy. In response to these concerns, the FDA has sponsored 3 studies of antiepileptic drugs and also convened an advisory board to help determine which drugs are NTI. The new NTI definition and new bioequivalence guidelines and their impact will be a major point of discussion during a town hall session held with leaders from the FDA during the American Epilepsy Society's 67th annual meeting in Washington DC.

Bioequivalence, a term used by the FDA to define specific criteria used to approve generic variations of brand drugs means that the versions of a drug produced by various manufacturers are expected to be used interchangeably without safety or efficacy concerns. A generic drug must produce blood levels within 80-120% of the brand drug in order to receive FDA approval. For drugs with a narrow therapeutic index, there are significant concerns among the epilepsy and neurology community that 80-120% may allow too much variability to ensure patient safety. Countless anecdotal reports suggest that manufacturer variations of antiepileptic drugs may cause changes in blood concentrations leading to loss of seizure control or other adverse effects, leading to serious mental, physical and social consequences for the person with epilepsy.
"Clinicians are concerned about balancing the need to control medication costs while ensuring the safety of generic drug switches. We are grateful that the FDA has listened to concerns and funded these critical studies on generic drug safety," said Michael Privitera, MD, Director of the Epilepsy Center at the University of Cincinnati Neuroscience Institute and Vice President for the American Epilepsy Society.
In addition to the town hall session two other new studies about manufacturer variations and bioequivalence were presented at the meeting.
One of the studies is part of the national FDA-funded clinical trial EQUIGEN (Equivalence Among Antiepileptic Drug Generic and Brand Products in People with Epilepsy). This particular series of experiments, led by researchers at the University of Wisconsin is an in-vitro screening of generic versions of the antiepileptic drug, lamotrigine. The goal was to find the two most different generic products to use in the human testing portion of EQUIGEN, which is using rigorous blood level testing in both single dose and multiple dose studies. The methodology identified disparate generic products for the EQUIGEN studies by demonstrating variations in dissolution time.
In a separate study, a survey of retail pharmacist knowledge and attitudes about antiepileptic drugs was conducted by Cincinnati Children's Hospital Medical Center and the University of Cincinnati. The study found that most pharmacists (73%) reported reservations when switching from brand to generic manufacturers for antiepileptic drugs. Pharmacists (80%) reported trying to keep the same antiepileptic drug manufacturer in stock for patients if possible. Most pharmacists (63%) believed the range used by the FDA to determine bioequivalence to be stricter than actual requirements. Of the pharmacists surveyed, nearly a third (30%) were aware of patients that experienced breakthrough seizures or side effects associated with manufacturer change.
"Pharmacists play an important role in the care of people with epilepsy," said, Lisa Garrity, PharmD, Clinical Pharmacy Specialist, Cincinnati Children's Hospital. "Our study reveals retail pharmacists share concerns surrounding manufacturer changes of antiepileptic drugs and highlights a need for additional education on issues associated with antiepileptic manufacturer changes for pharmacists. Communication between retail pharmacists, patients and epilepsy care providers is essential to safely utilize generic medications in patients with epilepsy."

</H1>
Reply With Quote
The Following 3 Users Say Thank You to Endless For This Useful Post:
Elsie (12-18-2013), Janus (11-28-2018), Nakamova (12-15-2013)
  #2  
Old 12-14-2013, 10:59 PM
epileric's Avatar
Super Moderator / Spaminator
 
Join Date: Dec 2007
Posts: 4,500
Thanks: 406
Thanked 1,308 Times in 939 Posts
Yaaay, Thanks for the post Endless.

It is great to hear that this issue is finally being addressed.

__________________
"It's no longer a question of staying healthy. It's a question of finding a sickness you like." -Jackie Mason
Reply With Quote
  #3  
Old 12-15-2013, 06:43 PM
Super Moderator / Thank You Queen
 
Join Date: Jun 2005
Location: Massachusetts
Posts: 16,473
Thanks: 948
Thanked 7,333 Times in 5,416 Posts
Let's hope it doesn't take too long to get the stricter standard enacted.
Reply With Quote
The Following User Says Thank You to Nakamova For This Useful Post:
Janus (11-28-2018)
  #4  
Old 12-15-2013, 08:01 PM
epileric's Avatar
Super Moderator / Spaminator
 
Join Date: Dec 2007
Posts: 4,500
Thanks: 406
Thanked 1,308 Times in 939 Posts
Most studies take a few years so I wouldn't be too optimistic about things being enacted too soon. Even once the studies are done it is very possible that pharmaceutical companies may try to oppose any redefining of standards so we may have to wait until that fight is over.
__________________
"It's no longer a question of staying healthy. It's a question of finding a sickness you like." -Jackie Mason
Reply With Quote
  #5  
Old 11-16-2018, 12:57 PM
New Here
 
Join Date: Feb 2008
Location: flint michighan
Posts: 7
Thanks: 0
Thanked 0 Times in 0 Posts

dilantin


does anybody know where I can find Dilantin that will not cost me an arm and leg?
Reply With Quote
  #6  
Old 11-16-2018, 02:04 PM
Super Moderator / Thank You Queen
 
Join Date: Jun 2005
Location: Massachusetts
Posts: 16,473
Thanks: 948
Thanked 7,333 Times in 5,416 Posts
Are you able to take the generic form (phenytoin)?
Reply With Quote
  #7  
Old 11-16-2018, 03:25 PM
New Here
 
Join Date: Feb 2008
Location: flint michighan
Posts: 7
Thanks: 0
Thanked 0 Times in 0 Posts
no
Reply With Quote
  #8  
Old 11-16-2018, 06:22 PM
Porkette's Avatar
Venerable Voice of CWE
 
Join Date: Mar 2016
Location: New York
Posts: 1,382
Thanks: 349
Thanked 427 Times in 379 Posts
Hi jerry1967,

You may want to try using cbd oil (medical marijuana) I buy it on line and it lasts me 3 months or longer. I've had epilepsy for 46 yrs. and had 2 surgeries to reduce my seizures but later on I found out I was drug resistant so I went on the cbd oil and I am amazed at how much my seizures have decreased. If you are interested check out the following web page. healthyhempoil.com I buy the mouth spray in the 1 ounce bottle and they mail it to me. I just use my debit card or credit card to pay for it and what I like about this group is if a person doesn't care for it you can send it back and they will refund your money within 90 days. I wish you the best of luck and May God Bless You!

Sue
Reply With Quote
  #9  
Old 11-26-2018, 09:45 AM
Bernard's Avatar
Your Host
Recent Blog: Oh poop
 
Join Date: Mar 2005
Location: Friendswood, TX
Posts: 6,520
Thanks: 773
Thanked 2,290 Times in 817 Posts
My wife was on Dilantin for many years and also had issues with the generics, so required the brand name. I'm a bit surprised at your post though because Dilantin was cheap compared to other anti-epileptic drugs. The patent on Dilantin expired a long time ago. Where are you buying it that it is priced at an arm and a leg?
__________________
New to CWE? I suggest reading the proactive prescription and epilepsy 101 threads. Also check out this chart of alternative epilepsy treatments and this page on EEG Neurofeedback. More great stuff can be found in the list of the best forum threads.

Would you like to help support this forum?
Reply With Quote
  #10  
Old 11-26-2018, 01:14 PM
New Here
 
Join Date: Feb 2008
Location: flint michighan
Posts: 7
Thanks: 0
Thanked 0 Times in 0 Posts
Because it is a brand and there are generics my insurance consider Dilantin Brand a Tier 3 which is expensive for me.

I was wondering if anybody knows if the Dilantin Brand that is in Canada is the same pill?
Reply With Quote
  #11  
Old 11-28-2018, 07:00 AM
Super Moderator / Thank You Queen
 
Join Date: Jun 2005
Location: Massachusetts
Posts: 16,473
Thanks: 948
Thanked 7,333 Times in 5,416 Posts
I can't attest personally to Canadian Dilantin, but it's by the same manufacturer (Pfizer) so it should be equivalent (depending on dose). And the Canadian pharmacies are well-regulated. See for instance: https://www.canadapharmacyonline.com...acyOnline.aspx
Reply With Quote
  #12  
Old 11-28-2018, 09:37 AM
New Here
 
Join Date: Feb 2008
Location: flint michighan
Posts: 7
Thanks: 0
Thanked 0 Times in 0 Posts
Trying to find out if all Dilantin 100mg Brand is manufactured in the same place.

Does anybody know?
Reply With Quote
  #13  
Old 11-28-2018, 10:54 AM
Super Moderator / Thank You Queen
 
Join Date: Jun 2005
Location: Massachusetts
Posts: 16,473
Thanks: 948
Thanked 7,333 Times in 5,416 Posts
Your best bet is to contact either the drug company or the pharmacist.
Reply With Quote
  #14  
Old 11-28-2018, 09:19 PM
New Here
 
Join Date: Feb 2008
Location: flint michighan
Posts: 7
Thanks: 0
Thanked 0 Times in 0 Posts
Drug companies will not tell you. They don't want you to know where it is manufactured.
Reply With Quote
Reply

Thread Tools

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off
Trackbacks are On
Pingbacks are On
Refbacks are On


Similar Threads
Thread Thread Starter Forum Replies Last Post
[News] FDA to Tighten Standards for Generic Antiepileptic Drugs epileric The Library 3 01-05-2012 06:27 PM
Fiance being switched from generic Dilantin to generic Keppra.. worried cncwheeler The Kitchen 10 09-18-2011 08:55 AM
Generic Drugs lhenchak The Foyer 9 03-13-2009 05:02 PM
FDA bans imports of generic drugs batman The Library 2 09-17-2008 11:37 AM


All times are GMT -5. The time now is 08:52 AM.


Powered by vBulletin® - Copyright ©2000 - 2019, Jelsoft Enterprises Ltd.
Content Relevant URLs by vBSEO ©2009, Crawlability, Inc.
Copyright 2005 Measuring Up. ALL rights reserved.