Google Answers Logo
View Question
 
Q: Currently available generic medication for atrial fibrillation and flutter. ( No Answer,   2 Comments )
Question  
Subject: Currently available generic medication for atrial fibrillation and flutter.
Category: Health > Medicine
Asked by: ironmike-ga
List Price: $2.50
Posted: 28 Aug 2002 18:16 PDT
Expires: 29 Aug 2002 17:34 PDT
Question ID: 59690
I'm told there are nine(9) generic substitutes,medications called
SOTOLOL to treat atrial fibrillation and atrial flutter,arrythmias
associated with the upper heart.I know that Betapace AF in 80 mg,120
mg,and 160 mg,is the only FDA approved sotolol,but in the interest of
saving money,what are the nine generic options on the market,and what
are the costs compared to the brand?
Answer  
There is no answer at this time.

Comments  
Subject: Re: Currently available generic medication for atrial fibrillation and flutter.
From: knowledge_seeker-ga on 28 Aug 2002 20:49 PDT
 
Hey Ironmike .. 

BE CAREFUL - 

""BETAPACE and the generic sotalols have a different indication from
that of the newly introduced BETAPACE_AF™," said John Williams, MD,
director of cardiovascular clinical research at Berlex. "It's
important for patient safety that we make sure healthcare
professionals are aware that BETAPACE or generic sotalols are not
therapeutically equivalent to BETAPACE_AF....

...BETAPACE and generic sotalol are only approved for life-threatening
ventricular tachycardia/ventricular fibrillation (VT/VF) and should
not be substituted for BETAPACE_AF."

http://www.betapaceaf.com/hcp/in_the_news/pr2.htm

--K~
Subject: Re: Currently available generic medication for atrial fibrillation and flutter.
From: voila-ga on 29 Aug 2002 13:03 PDT
 
Ironmike,

Please heed K_S's advice and put your $2.50 towards the brand name
Betapace, sir.  For any critical drugs for AFib/flutter or a drug for
anticoagulation (Coumadin), I would not play the fast-and-loose
generic equivalency game.  Check here: 
http://www.accfl.org/news-june2001.htm

"FDA regulations allow a fairly wide latitude in the definition of
“therapeutic” equivalence. In fact, they really rely on information
regarding so called bioequivalence and bioavailability, not
therapeutic equivalence. A generic substitution might be approved if
its bioavailability ranges from 80% to 125% of the parent innovator
compound. It would not be hard to understand that in the case of drugs
with narrow therapeutic indexes or toxicity windows that this might
not be an advisable policy. Some of our colleagues are seeking to
collect data and perhaps develop clinical trials regarding generic
substitutions in specific drug categories and patient populations.
This may shed some significant light on possible problems and whether
FDA regulations regarding evaluation and approval need to be
modified."

Your information is correct about the number of generic forms of
sotalol.  According to the Electronic Orange Book of Generic
Equivalents at the FDA site, EON Labs, GenPharm, IMPAX, TEVA, Mylan,
Mutual Pharm, Upsher-Smith, and Watson, besides Berlex, market generic
sotalol.  All are coded by the FDA as "AB" which means they're
"therapeutic" equivalents (see above).   However, if you check, I'm
guessing that your cardiologist wrote (no doubt illegibily) "Do Not
Substitute" or "Dispense as Written" on your script, rendering your
generic price comparison search moot.

You might also read this PDF document on drug substitutions:
http://216.239.35.100/search?q=cache:UcNTYuNgMksC:www.retailpharmacynews.com/specreps/rpn0117/0117.pdf+%22generic+antiarrhythmic%22&hl=en&ie=UTF-8
Some of this can be so much drug company hype, but I definitely
wouldn't cut any corners on your Betapace.
 
I'll pop in this weekend to mention some drug assistance programs for
you.

Respectfully,
V

(thanks K_S!)

Important Disclaimer: Answers and comments provided on Google Answers are general information, and are not intended to substitute for informed professional medical, psychiatric, psychological, tax, legal, investment, accounting, or other professional advice. Google does not endorse, and expressly disclaims liability for any product, manufacturer, distributor, service or service provider mentioned or any opinion expressed in answers or comments. Please read carefully the Google Answers Terms of Service.

If you feel that you have found inappropriate content, please let us know by emailing us at answers-support@google.com with the question ID listed above. Thank you.
Search Google Answers for
Google Answers  


Google Home - Answers FAQ - Terms of Service - Privacy Policy