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!) |