Posted on 12/19/2009 8:12:12 PM PST by neverdem
LET me start by saying I’m a fan of generic drugs. They save Americans billions of dollars each year and give us access to wonderful drugs at affordable prices. I’ve recommended generics in this column many times and use them myself when possible.
But there is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts. The problem is not pervasive, but it’s something consumers should be aware of — especially now that more insurers insist that patients take generic medications when they are available.
Let me also...
--snip--
According to Mr. Buehler of the F.D.A., to be considered bioequivalent, the generic drug must reach a blood serum level that is 80 to 125 percent of what the reference product achieves. But Mr. Buehler said that in reality the spread was not nearly that large. He noted that the F.D.A. conducted a large study and found that the average difference in absorption into the body between a generic and brand name drug was only 3.5 percent.
Some specialists, though, worry that the allowable range for bioequivalence is too wide, especially for patients who are taking medication to control problems like arrhythmias or seizures.
If a patient with the heart arrhythmia known as atrial fibrillation who also has risk markers for stroke gets a blood thinner for which the levels are too low, “there is risk for stroke, and if the levels are too high it could result in bleeding,” says James A. Reiffel, a cardiologist and professor of clinical medicine at Columbia.
Neurologists who treat epilepsy have similar concerns. Two studies published last year in the journal Neurology found that patients who switched from a brand-name product to a generic one had more seizures or higher hospitalization rates...
(Excerpt) Read more at nytimes.com ...
The FDA has to approve generics. The only difference between the generic and the brand is possibly the "fillers" or excipients in the tablets. The rates of dissolution, efficacy and safety are equal to those of the brand name.
This is probably more of an issue with extended-release formulations than with single-release formulations. The trouble with trying to test the generic extended-release formulations vs. the original brand product is that there’s also huge variation between individuals taking the same product. Partly because of different body chemistry, and digestive tract conditions, but also due to dietary variations (and the latter can result in a lot of variation within the same individual, if the drug is taken with varying amounts and/or types of food).
For all the wailing about being forced take generics, there’s the flip side, where huge numbers of people are steered to prescription drugs (which in most cases their insurance will pay most of the cost for), when an over the counter product would work just as well. Or better, as was belatedly discovered with the blood thinner Coumadin — a solid study found that most patients who’d been taking Coumadin would have gotten better results with plain old aspirin (though there were some specific conditions for which that wasn’t true).
My personal experience with one drug has shown otherwise. The generic version of Sonata, Zaleplon, has noticeably weaker effect than the Sonata brand. I’m pretty sensitive to this (and most) drugs, so I normally only take half of the smallest dose capsule of Sonata (when I take any of either one — I probably use it about 5-6 times a month). The full 5 mg capsule of the generic has about the same knockout power as 2.5 mg of Sonata.
First time I took Sonata, the doctor had prescribed the 10 mg capsule, which not only knocked me out fast and deep but also left me spacy through most of the next day. A couple of weeks ago, on a rare occasion when I’d taken 5 mg of the generic and was still awake a couple of hours later, I took another 5 mg and that worked fine to get me to sleep, but was definitely out of my system 8 hours later when I woke up without an alarm clock, feeling bright-eyed and busy-tailed :-)
Have relative who swears the generic she was given did NOT work...and really had to have the real thing....it must be a matter of physiology maybe? On top of the that...JUST BECAUSE the FDA approves of it, doesn’t impress me....
My husband was very fortunate and got off the heart meds after a couple yrs, as he developed secondary vessels to give good blood profusion. Those lasted 30 years before atrophying, and just this year he had to have 4 by passes-doing well but cannot take any of the heart meds except warfarin(bloodthinner) as the others make him faint. Thank goodness he had surgery last Jan., as he is 81, now and doubtless Obama's health czars figure he has lived long enough and can no longer serve the state in capacity of drone, so they would want to redistribute any remaining years he might have to younger folk, via denying him further care--just take a pill, sir, and it will soon be over.
vaudine
No, it's not a "penalty". It's cheaper to the insurance company to provide meds by mail for 3 months at a time rather than monthly at a local pharmacy, so they are passing along PART of the increased cost to the patient.
Shouldn't be. The active ingredient is exactly the same, and the excipients are shown, through clinicals and lab tests, to have the same rates of dissolution.
I’m on Trazadone due to sleep problems most likely from kidney failure and then transplant- kidney failure patients commonly have sleep issues. Anyway, Trazadone has me comatose within 15 minutes; have you tried it yet?
I can't argue with that as you're not in the industry. I certainly understand your doubts. But we are VERY sure of our results before we ever submit our products to the FDA for approval. For no other reason than the bottom line, and our reputation (again, the bottom line.)
If it's a generic from one of the big boys it's generally OK, the only generics (as well a brand names) I would avoid are those made by Indian owned companies.
Research Able Laboratories for instance
My 35 yrs of experience in the business tells me this is a psychological effect. Heck, much of the time the brand company makes the generic also. They just make more money on those dumb enought to insist on paying more.
That’s interesting. I wonder if I had a similar problem about 12-18 months ago. I was taking 25mg of metoprolol succinate (a generic extended release version of Toprol) along with my hydrochlorothiazide diuretic and generic version of Altace. My blood pressure was not under control when I went to the cardiologist. He increased my dose of metroprolol succinate to 50mg and things settled down. Later, when the generic was pulled from shelves due to manufacturing defects (some pills containing more than the stated dosage) I switched back to the branded Toprol. About a week ago, my pharmacy switched me to the new generic version. I’ll have to watch my pressure to see what happens.
Buehler? Buehler?
Works the same way with me, 15 minutes and I’m out. Only thing is, I just switched from taking 3 100 mg. tabs. to 2 150 mg. tabs just tonight. I went to sleep as usual but woke up at 1:30 am and can’t get back to sleep now.
I know all about Able. My company took all of their Lithium contracts following Able’s demise.
In the case of my Sonata, I don’t think so. It’s the first time I’ve noticed any difference between the effects of a brand and generic, so I definitely wasn’t expecting any difference. And I did use the brand again a couple of times afterwards, so it’s not just that my physiology has changed.
But as for the studies showing specifically that there’s a trend of changes in effectiveness for cardiac and seizure patients, I’d like to see that study adjusted for other significant changes in their lives. Generally speaking, patients’ changes from brand to generic drugs aren’t random. They’re more often the result of some life change that has triggered a change in insurance coverage — job change, retirement, going on disability, divorce, etc. However, some changes are simply the result of a generic becoming available for the first time. The two categories of patients need to be separated for a valid analysis. Heart symptoms and seizures are the sort of thing that one would expect to be aggravated by any significant life change, even a good one, since adjusting to a new routine invariably generates some stress.
An anecdotal example: a longtime cyber-friend of mine moved from the UK to US because her executive husband was transferred by his employer. They were both happy about the move, but it was a big change for both of them. He was on brand medication for epilepsy, and hadn’t had a seizure in several years. A few months after they arrived in the US, he had a major seizure while they were shopping together in a department store. She told me the doctors speculated it could have been due to the change from brand to generic, that was brought about by a change in insurance coverage when they moved here. Obviously it *could* have been due to a difference between the drugs, but it could also have been due to subtle physiological changes associated with the move — e.g. they’d moved to crowded, noisy, walking oriented NYC from I believe London, maybe he was keeping somewhat different work hours, or having a little more trouble sleeping due to noise.
I really don’t have much trouble sleeping. I take antihistamines (both for perpetual post-nasal drip and because it helps me sleep), 1 mg of melatonin before bed, 5 mg of Prozac 3 times a weeks (a microscpic dosage, but several years ago when I started it, it caused a long-standing problem of waking up around 3AM to magically, completely vanish), and I also wear foam rubber earplugs. I only need the Sonata occasionally, usually if my sleep schedule has gotten out of whack and I need to whack it back to getting to sleep earlier again, and 5 mg of the generic does the trick fine. It’s just that 2.5 mg of supposedly identical branded Sonata does the trick.
You’re the first person i’ve known of that thought Sonata, brand or generic, was worth anything.
You are correct, a large double blind study would be the only way to put the debate to rest, but no-one really wants it put to rest.
As far a the seizure, my experience has been that it is easier to blame it on a generic than for someone to admit they quit taking something correctly. Believe me, i’ve seen it all.
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