A few years ago, a patient of mine noticed some changes when he exchanged his brand-name antidepressant for the generic form. For the next month or two, he felt slightly apathetic and made some mistakes that caused him mild embarrassment. That can happen when the dose of an antidepressant is too high. But he feared that he would relapse if he reduced the dose, so instead he decided to return to the brand-name drug.
Why was the dose too high if he was still taking the same drug? The answer requires a closer look at the differences between brand-name and generic psychiatric medications.
Every medicine in the drug store has a name supplied by chemists. A drug company adds the brand name, which is often devised to evoke a healing image; for example, “Zoloft” suggests “aloft,” the opposite of being down in the dumps.
The company that develops a drug holds a patent giving it the exclusive right to sell the drug. That’s how it recoups the costs of research, testing, and marketing, and makes a profit. Once the patent expires, other companies can manufacture and sell the same chemical. Since they have not had to pay for research or marketing, they can charge much less.
The generic is not a “knockoff” of the original, like a fake Rolex watch. The FDA requires that a generic drug be essentially similar to the brand-name version. It should contain the same amount of active drug. It must be taken by the same route (for example, by mouth). And at a given dose, it should deliver about the same amount of active ingredient into the bloodstream — anywhere from 20% less to 25% more than the brand-name drug.
It doesn’t always deliver exactly the same amount because generic pills contain inactive substances that distinguish them from the original. In fact, the U.S. government actually requires this, to prevent fraudulent marketing. The otherwise inactive substances in a pill can affect how the active chemical is absorbed by the bloodstream, delivered to its target, and eliminated; for example, it may break up faster or more slowly in the gastrointestinal tract.
The healthy volunteers who serve as subjects in tests of new generic drugs usually receive relatively small doses. In real patients taking higher doses, the difference between the amount of active ingredient in the bloodstream in the brand-name and generic forms may exceed the FDA-approved 25%.
My patient and I were satisfied with his decision to go back to the brand-name drug. Although a lower dose of the generic might have done just as well, he did not want to take the chance of relapsing.
Another patient made a different decision. A pharmacist switched him from a brand-name drug to a generic form, and within weeks he noticed an uncomfortable warmth and flushing that lasted a few minutes every time he took the drug. Judging that this resulted from a rising blood level, I lowered his dose, and the uncomfortable feeling went away.
Reducing the cost of medication is a boon to all of us, and in most cases switching to a generic drug is uneventful. But anxiety about the change is normal, so discuss it with your doctor. If you notice new side effects (because the blood level is now too high) or returning symptoms (because it is now too low), a small adjustment will almost always put you back on course.
Have you ever noticed a difference when you made the switch from a brand name drug to a generic? What type of drug did you and your doctor ultimately decide was best?
Dr. Michael Miller has been on staff of the Beth Israel Deaconess Medical Center, a large teaching hospital in Boston, for more than 25 years. He is also an Assistant Professor of Psychiatry at Harvard Medical School.
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Comments: 22
What about the differences between manufacturers? Is that significant?
My doctor decided to increase one of my medications and after a month I told him that it was not working. We had to go back to my origional dose and start over. I believe that medication is not a one size fits all theory. I am all for saving money, but not when it wreaks havoc with my metablolism.
I had already thought about asking to go back to the non-generic, and have hesitated only because of the stupidity of drug companies who apparently decide which medications you should use based upon "low bid" purchasing! I already pay far more for one medication which I've refused to give up, even though I've tried the generics they demanded and even one medication that is now off the shelf--this is for acid reflux and I have found the original medication prescribed by MY DOCTOR to be the right one.
I sure wish the medical profession once again controlled what medications we should be on...without financially penalizing the patient!
Any thoughts on the generic paxil issue would be greatly appreciated.
Thanks for posting your comments. You asked about the useful of generics, because they're inconsistent.
Consistency may be one of the holy grails of life, but is very hard to achieve. Your comment that "medication is not a one size fits all theory" is absolutely right. Any time you make a change, from medication to medication, from brand name to generic, it's likely to make at least a little difference and sometimes it makes a big difference.
Theoretically, the generic drug should ultimately have the same effect as the brand if you get the dosing right. And in most cases, people make the shift from brand name to generic without a problem. But some people are truly sensitive to subtle changes in dose, so it can take a while to find the right dose of a generic preparation.
Unfortunately, cost is an issue that we can't overlook. My view is that it's an issue that should concern all of us (not just the insurance or drug companies). Benefits of treatment always have to be weighed against costs, whether they be financial or medical (that is, side effects).
So when a change wreaks havoc, it usually isn't worth the financial savings. The good news is that the change usually does not wreak such havoc.
Your experience with your medications sounds very frustrating.
One way to think about the problem is as two separate ones: the relative value of generic drugs and the question of WHO gets to decide about your medical treatment.
All things being equal, I do encourage people to take generic drugs. As I wrote above, there is usually no disadvantage to taking the generic and the savings are great for everyone -- you may pay less and there is less overall cost in the system.
I live in Massachusetts, which is the first state in the nation to try to make sure EVERYBODY has medical coverage. This is a good, but relatively expensive thing to do. Making sure medication costs are reasonable is one way to make sure everyone gets taken care of, and that's where generics come in.
But the other problem that you talk about is even more difficult. Ideally a patient should be free to make decisions about medical care with the help of a physician who provides the expert advice. Financial cost is a factor that we should all take responsibility for, but you point out that the money factor should not be the most important consideration.
You're right -- sometimes medical treatment does see to be dictated by a bottom line, low-bid mentality. And that can distort or limit a person's medical choices.
You wrote about getting a rash when you were switched from a brand name thyroid hormone replacement to a generic. In this case, it sounds like you reacted to something in the formulation of the pill -- that is, not the thyroid hormone itself, but to one of the other substances used to hold the pill together.
Allergic reactions are always hard to predict. It's good that you were able to get back on the medication that you need without having to suffer that rash.
You suggest that it would be great if you could try the generic drug first. That's a good idea with drugs that have been around for long enough. For example, fluoxetine (the generic name for Prozac) is now available in both forms, so it is relatively easy to start with the generic. But for medications that are relatively new, you don't have that option. In that case the problem comes up when the drug company patent expires -- that's when your doctor may suggest (or your insurance company may require) that you switch to a generic form.
You point out another issue that can come up with generic drugs. Each pill is a little different, may taste different, may dissolve differently, as you describe.
It's important to remember that there is usually more than one generic formulation of a drug. You talk about clonazepam (the generic term for Klonopin) -- there may be another generic form available that would have a more tolerable taste and might dissolve more readily.
Glad that you were able to adjust your dosage to get the effect you needed. The lesson here is that you and your doctor were alert to making the necessary adjustments!
I also have problems with my doctors NOT BELIEVING ME when I tell them I react very strongly to medications. Apparently my liver does not process drugs very quickly, and I get a "higher blood level than expected." For me, that means if something "might make you sleepy" it knocks me out. My doctors don't seem to believe me. I understand that often side effects get better after a couple weeks, but I have to be able to drive to work and *function* ... and I can't do it for two weeks just to prove to them that their pet medication is too strong for me. Sometimes I feel like my mouth is moving but nothing must be coming out, since my doctors don't necessary act like I said anything at all. "Let's try it for a while. See you in two months." What?!? Two months? I wonder what *they* would say if they told their doctor they couldn't do their job and their doctor said, well let's try it for a couple months?
Sorry if I seem bitter. I'm not very well controlled right now, holidays are hard, winter is hard (the light thing), my neice died recently, my oldest son won't speak to me, and now my husband is on my case because the house is a mess! Sheesh.
None of my prescription medications are generics, I keep asking my doctor about generics and apparently my meds aren't available as generic (Lamictal, Lexapro & Ambien CR). Maybe I'm not quite so anxious to switch to a generic now.
I am using other generic medications, so I too am quite willing to support the lesser cost...but, in the end, no matter who is saying what, the patient is the "only" person being affected by this "bottom line" philosophy. I feel that if I've given a generic a sufficient time period (I've been on it for at least a year) and I see and feel the old symptoms returning, then there has to be the ability to move back to the original...don't you think?
In any event, I'll be reporting on my $120 test in a month or so...