Are the generic drugs in your medicine cabinet safe and effective?

14th November 2008

Are the generic drugs in your medicine cabinet safe and effective?

posted in Drugs & Medications, Feminist Topics, Health, Nutrition & Fitness, Mental Health |

I had been on name-brand Wellbutrin XL for three years when my employer altered our prescription health care benefit plan so that if a generic drug is available, you must get it or pay the hefty difference out-of-pocket. In this case, that difference would be an additional $150 a month for name brand Wellbutrin. Alas, generic it is. I received my first batch of generic Wellbutrin last spring and immediately developed debilitating migraines each afternoon that made depression symptoms pale in comparison. My benefits plan is further structured so that I must use mail-order medication delivery. I don’t mind because the meds are often much cheaper than pharmacy co-pays, but you also have no control over which generic medication you will be sent. I’ve received several different generic Wellbutrin brands now and unlike their name-brand equivalent, all have some degree of unpleasant side effects.

I discussed these concerns with my doctor at our thrice-monthly appointment today and what she said surprised me – and maybe it will you, too.

Aren’t generic drugs the same?

A generic drug is a copy of a brand-name drug that ostensibly have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety and strength as the original drug. In other words, generic drugs are identical or bioequivalent to its brand name counterpart. The term “bioequivalent” makes you think the drugs are, well, equivalent, right? Not exactly.

The Food and Drug Administration requires the bioequivalence of generic products to be between 80 and 125 percent of that of the original drug. The agency determines bioequivalency with two tests. The first test determines whether a generic product is significantly less bioavailable than the brand name product. Bioavailability refers to the rate and extent of absorption of the test drug. The second test is basically an inverse of the first; it determines whether a brand name product is significantly less bioavailable when substituted for a generic product.

A difference in bioavailability of more than 20 percent in the first test is determined to be significant and will cause the generic drug to fail inspection. Likewise, since the second test measures the brand name drug, it cannot have more than a 25 percent deviance from the generic drug or the generic drug will fail – hence the 80-125 percent interval. If you’re wondering why the second number allows for greater deviance than the first, the original rule was supposed to be 80-120, but was changed to 80-125 to be symmetric on the log scale where most tests are conducted.

So, in non-geek speak, a generic drug can potentially be only 80 percent as effective as the brand name drug and still be considered bioequivalent. The FDA determines this 20 percent deviance to be statistically insignificant, but I’m not so sure. When taking birth control for instance, that 20 percent window looms awfully large. The FDA approved generic buproprion and insists it is bioequivalent to brand name drug Wellbutrin, but in a review conducted by the agency of generic buproprion manufactured by Teva versus the name brand Wellbutrin, even it concedes the prevalence of increased side effects and a loss of antidepressant affect in the generic version. That is, for the 150mg dosage. The FDA didn’t even test bioequivalency rates for 300mg dosages (which is the dosage I’m taking – how reassuring). Assuming that the 89 percent buproprion bioavailability rate at a 150mg dosage is similar for the 300mg dosage, that 11 percent deviance in effectiveness rate can mean a world of difference when you’re being treated for a psychiatric condition.

Pharmacies usually dispense generic as a rule unless otherwise requested and since prices fluctuate, you aren’t always guaranteed the same generic brand month-to-month. What this means is that you might take a generic drug one month that is 90 percent bioequivalent to the brand name and take another generic drug the next month that’s only 80 percent bioequivalent. Compounding this is the fact that when a company seeks FDA approval for a new generic, it must prove only that the active ingredient is the same. Each generic drug contains different inactive ingredients, fillers and formulations, which might cause treatment failures and also allergic reactions and side effects in drug-takers.

Other generic drugs problems:

Almost half of all prescriptions today in the U.S. are filled with generic drugs and according to my doctor, who is Indian, many generic drugs are now manufactured in China and India where quality control standards are far less stringent than in the U.S. Anyone remember the Chinese pet food scandal that caused the death of some 4,000 pets in the U.S.? You might also recall the massive Chinese toy recall or the more recent recall of tainted milk. In another scandal earlier this year, a dozen people died after developing a severe allergic reaction to the blood thinner heparin. The resulting investigation found that Chinese suppliers added a cheap, dangerous compound to the raw ingredient. The Chinese government passed a law last year to strengthen its drug regulatory agency, but the organization remains riddled with corruption nonetheless. Just how corrupt? Last year, the Chinese government executed the head of its drug agency for approving fake medicine in exchange for bribes kind of corrupt.

According to a Washington Post investigation last summer, generic products from India and China now dominate the generic and over-the-counter drug markets – India produces about 350 varieties and strengths of antidepressants, heart medicines, antibiotics and other drugs and last year China exported $675 million in pharmaceutical ingredients and products in the U.S. market. Yet the FDA conducted tests of only about 200 plants in those countries over a seven year period. By contrast, the agency made 1,222 inspections U.S. drug manufacturing plants last year alone.

My doctor appears well-informed about generic drugs, but not all doctors are. According to the American Heart Association, a 1997 questionnaire to assess attitudes, beliefs, knowledge and experiences with generic drugs and generic substitution was sent to 3,639 physicians nationwide. The report then focused on perceptions of the therapeutic index for 15 branded drugs and their generic substitutes. Only 17 percent of physicians could correctly identify the FDA standards for bioequivalency.

So, how do I make sure my generic drug is safe and effective?

Earlier this year the FDA asked for an extra $275 million to insure the safety of imported drugs and food, with a sizable portion of the money expected to be used to hire staff to inspect foreign drug plants. In the meantime, it’s virtually impossible for pharmacists or patients to identify the source of their medication, because there are no requirements for country-of-origin labeling of drugs and drug ingredients can pass through several countries before ending up on pharmacy shelves and in your medicine cabinet.

Consumerlab.com, an independent laboratory, tests supplements and medications but charges $29.95 a year for access to test data. The United States Pharmacopeia, another independent non-profit lab, sets the standards for all prescription and over-the-counter medication and other health care products recognized and used in 130 countries. USP issues a distinctive “USP Verified” mark to products that pass its stringent verification requirements. Participation is voluntary, but you might ask your pharmacist if the drug you receive is USP verified.

Not all generic drugs are less effective than name brand equivalents and considering the soaring costs of medication coupled with an economic recession, cheaper drugs may be the only option for many cash-strapped patients. It’s important to be to be vigilant of the medication brands you are taking. If you receive a different generic medication and it doesn’t seem to be working as well as the name brand or other generic version you took previously, take it back to the pharmacy or discuss alternate medication options with your doctor. If your prescription plan or personal finances mandate you buy generic and you find a generic that works well for you, ask your pharmacy for that specific generic brand on each refill. And if you prefer name brand, but your prescription plan provider won’t cover it without substantial cost to you, they may waive that extra fee with a letter of medical necessity from your doctor.

Anyone have similar experiences with generic drugs or have suggestions on how to make sure your drugs are safe and effective?

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This entry was posted on Friday, November 14th, 2008 at 1:49 am and is filed under Drugs & Medications, Feminist Topics, Health, Nutrition & Fitness, Mental Health. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

1 On November 14th, 2008, lilacsigil said:

I work in pharmacy in Australia – we have much stronger regulations than you, and thus our generic drugs are not as dramatically cheap as yours. Then again, we have universal healthcare, so insurance companies don’t get a say in which drug you have, though you may have to pay extra (usually between $1-2, the highest I’ve seen is $7.70) per month. I would appreciate it if you mention that your anti-generics article is US-specific and much of the problem is your country’s poor regulatory system, poor provision of health-care and excess control by insurance and drug companies. Generic drugs are not, in themselves, a bad thing.

That said, most generic drugs here are very similar to the original, and are often made in the same factory or on the same machine as the original! There are a small number which have storage issues (i.e. tend to crumble) and people with lactose allergies should be careful because one drug (original or generic) may contain lactose and another may not. The same goes for vegans. I am on four medications, and I use the generic brand for three of them – the other one doesn’t have a generic currently available.

posted on November 14th, 2008 at 2:02 am

2 On November 14th, 2008, zmama75 said:

About a decade ago I started taking generic bc pills (after taking name brand) & suddenly my breasts were very sore. After a few months of this I requested my doc to specify the name brand of my prescription. She did so willingly (although telling me shw didn’t understand why my body acted differently when generic meant the exact same as the name brand, heh) & my issue went away once back on the name brand.

I paid extra but maybe by $20 – definitely not $150. I would not have been able to afford that.

posted on November 14th, 2008 at 2:12 am

3 On November 14th, 2008, Meowser said:

Gahhh, like we mentally interesting folks don’t have enough hoops to jump through to find the right meds (and dosages) for us. And they just started me on bupropion, too, albeit as an adjunctive medication rather than a primary. (My current insurance requires I use generics when available, too. That seems to be SOP these days for group plans.) I’ve only ever taken the generic mirtazapine rather than brand Remeron and it seems to work okay, but I’d be really pissed if I found out that brand name Remeron was that much better and I couldn’t get it without a hefty surcharge. I don’t feel anything more on 100 mg of bupropion yet, although it’s been only two days.

posted on November 14th, 2008 at 3:13 am

4 On November 14th, 2008, Jackie said:

I should let my mom know, she was right to send by generic versions of my anti-depressants when some slacker at the drugstore, didn’t feel like processing the original version of the medicine. I wonder if “We were just trying to save you money” is another way of saying “I didn’t want to go to the back of the aisle to actually get the correct drug”

posted on November 14th, 2008 at 3:32 am

5 On November 14th, 2008, Sarah said:

Wow — I consider myself a fairly informed consumer, but I had no idea about this. Thank you Rachel.

posted on November 14th, 2008 at 7:02 am

6 On November 14th, 2008, The Bald Soprano said:

When my insurance back in the states (now I’m on a different one here in Germany) did the switch to requiring generics, my BC was switched, and the generic version made me bleed 3.5 weeks out of 4. Not. Acceptable. I wound up switching to a totally different kind where a generic wasn’t available yet. I don’t even think I could talk the pharmacy into letting me pay for the non-generic, actually, they just kept saying that it was identical.

My grandmother was switched to a different generic once and either she had an allergic reaction to a filler or the filler reacted with one of her other medicines, and boy did we have a time straightening that out! It affected her balance and gave her brain fog –she was afraid she was going crazy!

Here in Germany so far I’ve only been asked if I would accept an export-import form (made in germany for sale in the Netherlands or Italy or Belgium and then re-imported –don’t ask my why this is cheaper) –but I’ve always said yes, and it’s still the name brand (which country it was made for seems to be determined by the type of BC –I’ve been on three since I’ve been here– and the length of the prescription, three or six months). Of course, I haven’t gone through the hoops to try to get my insurance here to cover my BC yet (it’s MUCH cheaper here than in the states, like 30% of the cost). For my thyroid medication, they actually ask me which brand I’ve been on so that I’m on the same brand every time. For the metformin, it just has been the same brand every time.

posted on November 14th, 2008 at 7:39 am

7 On November 14th, 2008, Leanne said:

I was on Micro-Nor birth control pills for about a year before they switched me over to generic. I was pregnant in four weeks! I tried to talk to the doctors at Planned Parenthood about this, but was basically brushed off. I promise you it was not user error. I consider myself lucky that I was in a situation where I could actually keep the pregnancy and child. Many others may not be in similar crcumstances.

posted on November 14th, 2008 at 9:21 am

8 On November 14th, 2008, Rachel said:

Lilacsigal wrote: I would appreciate it if you mention that your anti-generics article is US-specific and much of the problem is your country’s poor regulatory system, poor provision of health-care and excess control by insurance and drug companies.

I remain very U.S.-centric throughout the entire piece, so I’m kind of puzzled by this. Unless, of course, there also exists an FDA for the world, I don’t know how you could not realize I’m talking about the U.S.

Leeanne: That’s horrifying! Especially when they reassure women that the pill is 99.9 percent effective. Yet another reason why I’m getting the copper IUD instead of using birth control.

posted on November 14th, 2008 at 10:07 am

9 On November 14th, 2008, Alice said:

YES. This is a huge problem with psychotropic medications (as well as BC) and it just sucks. Some medications aren’t all that finicky – if you have a lower dose one day, and a higher dose on another, it evens out in your system because they have long half-lives. But the teeny tiny amounts that you’re dealing with in antidepressants (and antipsychotics, etc.) are ASTONISHINGLY responsive to little fluctuations. I’ve worked with people who have very strong reactions to generics, and while it’s a pain and a half, there’s often a way to get that pill to be more covered by insurance than they want to admit initially.

This info is true for all sorts of generics, too – even over the counter ones. I thought I was just a snob when the Wal-itrin didn’t work as well as Claritin, but it was actually the drug itself. I felt a lot less crazy when I found out about the ridiculous (lack of) standards for US generics. Also? IUDs rock! Be sure to ask for LOTS of novocaine and take some (name brand) Advil ahead of time, especially if you’ve never given birth – I’ve got a particularly wacky cervix, but going through insertion with no medication was a ridiculous charade of pain.

posted on November 14th, 2008 at 10:25 am

10 On November 14th, 2008, demimonde said:

I have to be honest, the title to this post really ticked me off because I’m one of those people who doesn’t have a choice. I am too poor to afford brand name food, let alone medications!

But then I actually read the post, and I’m more scared than mad now. (Although there’s still plenty of mad left over for the ridiculous health care system in the US, trust me.)

I take generic bupropion too! And I know exactly what you mean about the headaches! I thought I was alone, and to see that there’s a reason, and I’m not just crazy… wow. That means a lot. And it is reassuring that I can ask for the same generic brand (doesn’t that sound like an oxymoron?) because the one I’m on now is fine.

I’m going to my Dr. today to try and get a cheaper BC, so great timing! Thanks!

posted on November 14th, 2008 at 12:28 pm

11 On November 14th, 2008, Pegkitty said:

I take, and have taken, several anti-depressants, and generally get put on the generics as soon as they are available, as that’s what my insurance requires too. I can absolutely confirm that there are differences between generic buproprions. Simply, one works for me, and one doesn’t (or doesn’t work enough – there is a clear and definite difference). Luckily the first time this happened I asked my shrink about it, and she confirmed for me that generics are not exactly the same as the name brand, and can be quite different from each other as well – although her explanation hinged mostly on the fillers/additives differences that might cause problems, rather than the “bioequivalent” issue.

posted on November 14th, 2008 at 1:38 pm

12 On November 14th, 2008, OlderThanDirt said:

Are you compiling statisics? Because, I’m another one. I take generic Wellbutrin and one brand of generic gives me INCREDIBLE headaches and one doesn’t. I’m also a little weird with the dosage thing, evidently I don’t flush drugs out of my system very quickly so my standard dose is 150 mg a day which is usually the starting dose. If I take a more standard dose, even of brand-name Wellbutrin, I can get headaches (and not sleep, too).

posted on November 14th, 2008 at 2:41 pm

13 On November 14th, 2008, Rachel said:

Wow, it’s kind of reassuring to know I’m not the only one who gets headaches from generic bupropion, even though I’m also sad to hear that others have my same misfortune. I have no easy answers, but I will say that the last generic I got from manufacturer from either Global (I think) caused me to have headaches for more than a month before they subsided. I now have generic Wellbutrin from manufacturer Teva and I only had headaches for just a week with it. But, as I warn in my post above, the Teva generic has also been shown to have less of an antidepressant effect in some people, so it’s a trade-off.

posted on November 14th, 2008 at 2:49 pm

14 On November 14th, 2008, Erika said:

Like zmamma, I also had adverse reactions to my generic birth control. I spoke to my doctor, but unlike zmamma’s she gave me the exact same explanation as your doctor did, and she immediately put me on a bc pill that had no generic “equivalent” because my employer then also had the same provision (if generic is available, then generic it is). My new employer does not have this provision, probably b/c as a large consulting firm, it is aware of the differences between generic and brand name drugs (or at least, this is what I like to think). My bc pill recently became available in generic and the pharmacy actually called me to ask which one I prefered. That was so refreshing!

I was agast when I heard the explanation for generic drugs.

posted on November 14th, 2008 at 3:19 pm

15 On November 14th, 2008, Bree said:

Normally generics don’t bother me, but last year when I was diagnosed with a pinched nerve, the doctor prescribed me Torodol. I had no insurance at the time, so all I could afford was Keterec. The drug caused side effects in me comparable with a gastrointestinal virus less than 8 hours after taking it. Not only did I have dizziness, nausea, and diarrhea, I also experienced some vaginal bleeding. As soon as the drug was completely out of my system, my health was back to normal. The brand-name Torodol (injection form) gave me no side effects at all.

My OBGYN wrote me a prescription for Ponstel to alleviate severe menstrual cramps I’ve been having the last four periods. Ponstel is like Torodol, an anti-inflammatory, so I have to be extremely careful when taking this drug to make sure I do not have any more gastrointestinal problems.

posted on November 14th, 2008 at 3:52 pm

16 On November 14th, 2008, Raina said:

I had a similar experience – when I went from Wellbutrin 300mg XL to generic (the large green oval pills) I immediately began to feel like I had forgotten to take my medication – I was tired, I got migraines, and my depression worsened. After about 5 days I noticed I was having a hard time walking straight (my feet were crossing center). I was lucky because I was able to switch doctors and get back on the brand name medicine but I was a little funny in the brain for weeks afterwards. I have heard a lot of other people having experiences like this with generic wellbutrin – the FDA is investigating. http://www.consumerlab.com/news/Generic_Drugs_ToprolXL_Metoprolol_Succinate_Extended_Release/3_17_2008/

posted on November 14th, 2008 at 4:35 pm

17 On November 14th, 2008, Cindy said:

Reading this, I feel profoundly fortunate to be in such great health. I do live with a low hum of anxiety, but I’ve been able to manage it so far without medication.

posted on November 14th, 2008 at 5:23 pm

18 On November 15th, 2008, Bronwyn said:

I first learned that generics weren’t necessarily exactly the same as the name brands when a friend of mine had an issue with her daughter; The dosage/bioavailability of the drugs was just different enough between the name brand/generic that she was getting overdosed when the pharmacy was switching back and forth.

It makes me ill to think about because of the huge price difference; And with wellbutrin, even the generic isn’t cheap; It’s still $170 a month without insurance at my local pharmacy.

posted on November 15th, 2008 at 5:25 am

19 On November 16th, 2008, Rachel2 said:

Oh. My. Gosh. That’s awful. Are you serious?!

I’ve been fortunately blessed to have a doctor that knows what he is talking about and what he is prescribing for me. I am on a Patient Assistance Program for name brand Lexapro (and won’t be going to generic, thankyouverymuch!) and I have been very, very blessed to have these meds. I’ve been on Lutera (BC) for several years now, and right now, and only now, due to human error (I biffed the cycle-yes, it was me. Only me! LOL), I’m dealing with a possible pregnancy. My body chemistry has changed for the moment and I am no longer in need of the Lexapro, fluoxetine (generic Prozac, which has worked like a charm for my monster PMS), and methylphenidate (generic Ritalin) cocktail. My people at Planned Parenthood have been wonderful to keep me on the BC that works (until I biff it! lol), and any time I’ve had a question or requested a different brand of BC, they’ve been more than happy to oblige. Of course, I’m on state funding for that as well, so it probably really doesn’t matter.

That being said, it’s appalling how our health care system is being managed here in the US. Absolutely and utterly appalling. I am careful with generics, but generally buy them because I am so damn strapped for cash. I am very fortunate to be in the city that I am, because of all of the funding and public assistance available. It’s funny, I work 3 jobs, and I still can’t even begin to afford health insurance. Ridiculous.

posted on November 16th, 2008 at 3:14 am

20 On November 16th, 2008, ladyinanet said:

Thank you for sharing this technical and very helpful information.

I have been dealing with trying to monitor, as best I can, changes in my moods as a result of my pharmacy’s distribution of two to three different generic versions of my anti-depressant Paxil.

My doctor explained to me the allowable range to meet “bio-equivalent” standards/requirements after I made an inquiry. The pharmacy frequently switches generic brands. I requested that they give me the same generic every time I refill. I was told that wouldn’t be possible because the buy the generic that is cheaper at the time of purchase.

I am outraged that I had to find out about the effectiveness of the generic versions of my meds from my doctor only after asking because I experienced dips in my mood. Isn’t it (if not it should be) the responsibility of the pharmacist to disclose the difference in effectiveness and not just that the shape of my pills have changed?

Thanks for your informative post. I have been trying to research this on my own with no success.

Lady In A Net
Logging and Losing
http://loggingandlosing.blogspot.com

posted on November 16th, 2008 at 7:23 pm

21 On November 17th, 2008, Kate said:

Like some of the other posters I had problems with my BC when I had to switch to generic. I took Ortho-Tri-Cyclen for acne for years with no problems but as soon as the generic came out and I started taking it I was constantly spotting. Luckily the PA I saw for GYN stuff also knew that there could be issues with generics and had no problems with me switching pills. We tried two other pills but when the second one (which was working without spotting) also had a generic come out after I had been on it a few months I just gave up. I continued to take the generic for a while but we used condoms as well since I wasn’t confident about the effectiveness of the generic BC. After a lot of research I decided to get a Mirena IUD which worked great. Although I hear it can be hard to get an IUD if you haven’t had a baby I didn’t have any problem at all. Plus, fwiw I had mine removed this summer and was pregnant 2 weeks later (on purpose). It made me really glad that I had been so careful with the BC over the years

posted on November 17th, 2008 at 11:33 am

22 On November 17th, 2008, Rachel said:

That’s reassuring to hear, Kate. I’ve only been on generic forms of BC and all have resulted in unpleasant side effects and like you, I’m not reassured of the effectiveness of generic BC. I’m considering the ParaGard copper IUD which is hormone-free and is effective for up to 10 years, but also easily removable.

posted on November 17th, 2008 at 1:07 pm

23 On November 23rd, 2008, Debra Jordan said:

I am currently trying to find my lisinipril(generic for prinivil) that does not come from a foreign country. Whatever! I did get my pharmacist to order me a different pill from a different manufacturer – maybe it will help. Conrolling high blood pressure is no laughing matter. I think it is a shame that our country has stooped to oursourcing medication, something that controls the health of our citizens. I think America has thrown her brains away for a buck!

posted on November 23rd, 2008 at 9:58 am

24 On February 10th, 2009, Bitter pills to swallow » The-F-Word.org said:

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posted on February 10th, 2009 at 12:56 pm