I’ve been on Risperdal for about 14 years. I’ve been waiting for it to go generic for about 6 years. Patents used to be much shorter than they are now. For a long time I would try to find out when it was going to become generic because I wanted to save money. Now that the date is upon me I’ve learned a lot more since I first waited for the day that the generic would become available.
I’ve learned that generics are often not very much at all like the brand name in that our bodies can process the drug very differently because of inert ingredients. Since I’ve learned about this I’ve become increasingly nervous about that day in June this year that Risperdal goes generic. I’m only on .75 mg of Risperdal now, down from 11 mg, but its now at the tail end of the taper that it’s gotten really ugly—that minute changes feel gargantuan. So I read this article in today’s LA Times about loose FDA standards for generics with growing dread.
As the article says:
In almost all cases, the FDA permits a generic drug to release 80% to 125% of an active ingredient into the bloodstream, compared to that released in a single dose of the original medication. That range would make little practical difference in the effect that most drugs have. And the FDA and generics manufacturers defend the allowable range of variance as the same that is permitted among “batches” of brand-name drugs.
But medical and pharmacology specialists warn that the FDA’s range may be too broad for some drugs, especially in cases where a drug has a “narrow therapeutic index” — the fine line between an ineffective dose and a dangerous one.
And definately too broad when I’ve been cutting down by only 10% at a time. If the drug is 80% of what I’m taking that is a 20% cut without intending a reduction. It of course can work the other way and make coming off the drug a longer task and more difficult if it’s actually 125% of the brand name.
Anyway I knew all this already, but the article brought up my fears again. I’m on Medicare and they won’t be paying for my preference for the brand name. I have to hope for the best.
For more on this topic also from the LA Times see: Generics: Just as good?