Generic Drugs: Not Always The Same?

By Healthcare Hacks on 30 December 2009 (Updated 1 March 2010) 6 comments

In the world of prescription drugs, generic equivalents have been a financial blessing for many patients, saving them millions, if not billions, of dollars each year. For the most part, they perform the same function as brand name drugs at a fraction of the cost. A recent article in the New York Times, however, has indicated that some generic drugs might not work as well as their brand name counterparts.

The evidence thus far, however, has been largely anecdotal. People have reported on various websites, including People’s Pharmacy, that when they switched to generic drugs, either they did not work as well or they experienced adverse side effects. The take home message from all of this is that not all drugs are created equally, and generic equivalents might in fact not do as good of a job at alleviating ones’ symptoms.

This is of particular concern when the medication involves ailments whose side effects can seriously affect a person’s health, including the fields of cardiology and neurology. In fact, the American Academy of Neurology has gone so far as to say that they are not in favor of generic substitutes for certain anticonvulsant drugs (for treating epilepsy) without proper physician’s approval.

The issue, to say the least, is controversial. The insurance industry is particularly supportive of generic drugs and often insists that they be used (or else incur a penalty in the form of higher co-payments), and the Food and Drug Administration (FDA) as well as the American Medical Association (AMA) both agree that generic drugs work just as well as brand names. But there are an increasing number of incidences that seem to tell a different story, and the growing wave of concern is causing the field of medicine to take notice.

Generic drugs are essentially a cheaper alternative to brand name medications. When a new drug hits the market, it maintains patent protection for twenty years. When the patent expires, other drug makers can rush into the market and sell the drug at a lower price.

According to the FDA, the generic equivalent must have “the same active ingredient, dosage form, and strength,” as its brand name counterpart, though not necessarily identical. It must also be bioequivalent, which means that it must result in blood levels of the active ingredient that are very similar to the brand name drug.

To be considered bioequivalent, the generic drug must achieve blood serum levels that are 80% to 125% of the reference level, a range that some experts feel is too wide and might possibly result in the reduced absorption, and thus effectiveness, of a drug. This is especially important when treating heart conditions and seizures.

Interestingly, the differences might even be of concern when switching from one generic brand to another, and the patient might not even be aware of the change due to the fact that pharmacists are not obligated to inform them of it.

For now, there have not been any well established clinical studies that offer concrete evidence that generic drugs are in fact less effective, and experts contend that in most instances, generic drugs work just fine.

If you have concerns, speak with your physician. If you have questions about the brand or makeup of your medication, discuss your concerns with your pharmacist of insurer.

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Guest's picture
babelfish81

...but the variance in bioequivalency can also likely make a difference in birth control pills. As a nurse, I know it's recommended that when switching the pill you're on, you should use backup protection for the first month until your body adjusts to the level of hormones in the new pill. Now imagine getting a different generic pack of pills every month; there are literally dozens of manufacturers of generic birth control pills, and your local pharmacy usually buys from wherever they can get the best price.
The other big one is thyroid medication and blood thinners. The generics of these often don't work as well as name brand. It's best to either always take name brand, or always take generic.
Most of the time, generics are great. Not always. And for the most part, they are certainly better than nothing. If you're concerned about it, talk to your doctor and pharmacist about what options are best for you.

Guest's picture
Carolina

Generics can be good, but I learned the hard way why many in the pharma industry say they would never take them. I have to take Lamictal for a depression-related illness and until last summer, there was no generic for it. Once the generic came out, my insurance covered it for the standard $10 co-pay (for the brand, I'd have to pay $150 for one month's supply). So I tried the generic and almost went nuts. My mind was foggy, I couldn't "get the words out of my mouth" and my problems w/depression-related stuff immediately resurfaced; this happened immediately and went on for the month I stuck it out. I finally spoke w/my doctor who said that it's often a crapshoot w/generics like this one since the binders (the stuff that holds the compound together) are not usually the same as the brand (& can often change from batch to batch), thus all my horrid reactions. So I had to suck up the higher co-pay if I wanted to function fully. I will never, ever take a generic again as this was a complete disaster that could have had truly serious implications on my health.

Guest's picture
Guest

My first bad experience was when I was taking Zantac. When it became generic, my heartburn got so bad, I was in a panic. It was the med not working, so what about meds that you can't "feel" how they work. Second experience was with generic prozac, didn't work at all, got around that by asking the doc to double the dose. As a nurse I wonder how many people we label non-compliant when their generic meds are to blame?

Guest's picture
Guest

Thanks for posting this article. I work in health care and see this problem every day. For some medications, generic equivalents would be just fine. But for many meds (antiseizure meds are a good example) the medication has what we call a "narrow therapeutic window." That means that the drug dosage has to be carefully calibrated for the individual patient. Too high and there are major side effects. Too low and there are breakthrough seizures. Often it can take weeks or months to figure out the appropriate dosage of medication needed to control a particular person's seizures. Since generic meds are allowed to have 80-120% blood levels, you can imagine how switching from one generic to another every month can really mess up that patient. It is essentially like changing the dosage of medication every month! Now imagine if you were an epileptic patient. Having seizures is no fun--and it is also life threatening. Many states have laws that disallow patients from driving until they are 6-12 months seizure-free. Without transportation, how do you hold a job? But,the out-of-pocket cost of the brand name drugs is often much more than the patient can afford. We are truly putting these patients in a Catch-22 by insiting that all generics are perfectly fine for all patients. Sorry, but medicine will never be a one-size-fits-all thing.

That said, I do think that generics have a place as a substitute for brand name meds without that narrow therapeutic window. I just think a doctor should make the determination, rather than an insurance company.

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Bijan's mom

My dog was on (human) anti-seizure medicine for years. After several years of getting this same medicine at my vet, one day I noticed that the pills looked different. I called, to see if there was a mix-up. I was assured that the pills were fine, just a generic and they had switched to pass a cost-savings on to their patients (I can't remember if I paid less that day, it's been a few years). Anyway, I gave my dog the pill that night, and then, another one in the a.m. My husband found our dog in a full-on seizure, near death. later that day. We ran him to the vet, and I was assured that the new (generic) medicine was NOT the cause of the problem. I did not believe them, and insisted that they order me the non-generic medicine for my dog. We never had another problem, and my dog lived for several more years, but every time I went to pick up my dog's medicine, I got the vibe from the front desk staff of "There's that crazy woman who thinks her dog got bad medicine". Right....we would have switched to another vet office, but the next one was far away.

Guest's picture
Lu

I am a firm believer in generics, many can and do work as well as the original. It's no biggie to find out that the generic for hay fever didn't work, bummer - my head's stuffed up an extra day. However, when referring to medications used to control seizures (there is no cure, only control) - it's a whole new ball game. I have two family members on two different brand name drugs, and have to fight with the insurance, and even more importantly the ER Doctors, who can't understand why the generic could be a problem. Yes, we need to take care with health care expenses, but it needs to be done with full awareness of the situation.