Melinda Beck of the Wall Street Journal has written about the generic drug controversy. You can read it at: Health Journal.

Years ago, we loved generic drugs and encouraged patients to request that their doctors prescribe generically whenever possible. The savings were phenomenal, even 20 years ago.

 The savings are even better today. A $4 generic prescription for a 30-day supply of fluoxetine at a discount pharmacy chain is certainly much cheaper than a month’s worth of Prozac, which can cost as much as $175.

The only problem with this otherwise rosy picture is that everything depends upon the FDA’s vigilance to ensure that all generic drugs are indeed identical to their brand-name counterparts. Over the last several years, we have begun to doubt the government’s ability to do this job adequately.

Put aside for a moment the whole issue of medications imported from countries like China and India. The heparin horror highlights questions about how well such ingredients are monitored for quality control.

We thought that the FDA required every generic drug to be tested for equivalence before it could be approved and sold. Now that the FDA has published the report of its investigation, we know that is not the case. Budeprion XL 300 (a generic formulation of bupropion, meant as a substitute for Wellbutrin XL 300) was not subjected to bioequivalence testing. Instead, the FDA allowed the company to submit data for a pill containing half the dose (Budeprion XL 150).

Although the FDA says Budeprion XL 300 is good enough, its own report regarding the time to maximum blood levels (Tmax) suggests that the 150 mg pill behaves differently in the body: “The bupropion Tmax was faster for Teva’s XL product (2-3 hours) than Wellbutrin XL (5-6 hours).”

This could account for the experiences people have described on this Web site about side effects and depression, such as this one from BK:

“In March of 2007, my insurance company switched my Wellbutrin XL 300 to the generic-Budeprion. Within six weeks, my depression had returned full force.

“In May, my doctor put me back on Wellbutrin and within 2 to 3 weeks, I was fine again.

“Obviously, in my case and in many others, Budeprion does not work. In many cases, [people report] it has even done harm.”

Melinda Beck of the Wall Street Journal has summarized the controversy extremely well. You can read it at: Health Journal.

 This is a demonstration of how e-patients can inform each other and influence policy.

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  1. julie
    Reply

    Mine smells like vinegar also. Has anyone answered your question? Is it safe to take?

  2. Rx
    Reply

    Remember that old saying: You get what you pay for.

  3. DHS
    Reply

    Don,
    I know your question is a year old, I saw it the other day when I was trying to find out why my budeprion smelled fairly strongly of vinegar. I’ll leave this note here because its likely someone else is looking for the same information.
    I spoke with a CVS pharmacist. He told me it was a result of the color of the bottle combined with high temperature and humidity. So, okay. I took all the pills out of the bottle and put them in a baggie without closing the baggy. It was immediately evident that the bottle smelled more strongly than the pills. I left both open on the kitchen counter overnight. The bottle was still noticeable, but milder. The pills didn’t smell at all. The pharmacist said it was probably was the bottle at this point and I could put the pills back in. I’m leaving them in the baggie. This may or may not be what was going on for you. But, I hope someone finds this helpful.

  4. Alice D.
    Reply

    Hi: I have been on Topomax for years as a migraine prevention and have never had any negative side effects at all. Recently my insurance changed and I was given the generic form for my mail in prescription of 90 days. I happen to get a pretty bad yeast infection about that time which I treated with over the counter meds. The infection kept returning, or what I thought was an infection.
    After several doctor visits and several hundred dollars on “special” medication to get rid of the infection nothing was working. I kept thinking it was a new soap, anything. Then I forgot to take my medication one day and did not have the vaginal discomfort. The next day I took the medication and felt like a lot of burning and discomfort in the vaginal area. I connected the dots and got on the net and found out the that generic form of topomax which is topiaramente has a side effect of vaginitis. Blew me away….

  5. don
    Reply

    anyone know why my generic wellbutrin (bupropion) smells like vinegar?

  6. Donna G
    Reply

    I was so glad to read up on these generic medications. My friend, who gets all the medical reports, called me to inform me that my generic Budeprion had some bad side effects. I pulled all the information up, and sure enough, I can now account for the crying spells for no reason; the “lets end it all”, I can’t live like this.
    Then I noticed that there was this awful smell from the budeprion when I open the container. I was concerned, so I read the med info sent and it states that there is no harm in the med if there is a strong smell. Today, I did not take it and for the next week I will try to do without it and see if there is a difference.
    I am also going to print up the articles and send them to Aetna Pharmacy along with my complaints about the medication. I still pay $135.00 for 90 day supply that makes me feel worse instead of better. I hate to see what other generic meds are out there ready to kill us just so the Ins Companies can save money.
    Keep up the good work. I have this site as a favorite. Being a Nurse, dealing with patients every day, all this info will come in handy.

  7. KAM
    Reply

    I quit smoking 8 years ago using name brand Wellbutrin. It worked great. I quit smoking for 6 years and have smoked again for 2. Putting my mind to quitting again, I got a script for Wellbutrin. My insurance, like most these days pays ZERO for name brand. I tried generic. Since I don’t suffer from depression in the first place, I can assure you this was not “natural history of depression.”
    Within 2 days I felt horrible. I was emotional and weepy and well…..depressed! I quit after the 4th day. Generic is NOT the same and the insurance companies have driven us to having no choice in name or generic. I wouldn’t put generic oil in my car, why would I put generics in my body?

  8. sjf
    Reply

    I sat in my psychiatrist’s waiting room one day looking at all the brochures left there by drug sales reps. “Choose a malady,” I thought, “for a day or a week or forever.” It occurred to me that every new wonder drug touted contained an inordinate number of the consonants: V, W, X, Y and Z! Have they already used up every possible combination of the previous 21 letters? Or do the last five just sound more exotic? Why should any of this suggestible garbage be left in the waiting room of all places?

  9. MB
    Reply

    I concur with the skepticism regarding the names of some of the Labs drugs are being manufactured at, i.e. Dr. Reddy’s Lab (as soon as I saw the rx label, I remember turning to my husband and say, “sounds like a mad scientist”). (But I think that other names such as the ones being used to market the new yogurts and their ingredients for digestive and brain health, sound like some young ad execs. sitting around brain storming trying to come up with names that sound like drugs). I am quite skeptical of prescription drugs these days and search for alternatives (in vain sometimes).

  10. Greg
    Reply

    Phil: The DSM-IV is the Diagnostic and Statistical Manual of the American Psychiatric Association, version 4. It the book of criteria by which all mental-health disorders are diagnosed. It is used by all Psychiatrists, Psychologists, Counselors, Social Workers, Marriage and Family therapists in the USA and many other countries as well.

  11. Lily
    Reply

    I’ve seen ads on TV for Caduet. It has two ingredients. One is Amlodipine and the other is Atorvastatin. With my RxDrugCard I can get 30 tablets of Amlodipine for $9 and 30 tablets of Simvastatin for $9. I’ll bet they are charging more than $18 for this new drug! Don’t pressure your doctor into giving you something just because it’s new. Do your homework. Find a drug card like I did at http://www.rxdrugcard.com. I think that RxDrugCard.com is the best drug card available for prescription discounts.

  12. jkk
    Reply

    Just read comments of 4/26by phil and I’m curious to know what DSM-IV is? Is this a standard test used for diagnoisis for depression? I’m truly feeling compassion for your situation. Sometimes I think it would be great to speak to a doctor who has experienced the same dark empty feelings of hopelessness those of us who suffer from depression live with year after year. I cross my fingers hoping my medication will not suddenly stop working. jkk

  13. phil
    Reply

    Let’s see. If I understand the FDA correctly, the misery that I experienced following a change from Wellbutrin XL 300mg to Budeprion XL 300mg is simply the “natural history of depression.”
    I began taking Wellbutrin in 1995 for ADD symptoms. Around this time I experienced my first major depressive episode as determined by the diagnostic criteria in the DSM-IV. It was treated with Prozac, without changing the dose of Wellbutrin. The trigger for this was a very significant loss. Shortly after Wellbutrin SR went on sale, in 1996, I was changed to the SR version. I had another major depressive episode in 2000, triggered by two more, almost simultaneous losses. It resolved without additional medication. Then again, shortly after the XL version went sale in 2003, I was changed to the XL version. Since that time I have experienced no losses. In September 2007, my insurance company dictated the change from Wellbutrin to Budeprion. I began experiencing the effects that others have described in detail shortly thereafter and, by the time I became aware of the “controversy” surrounding Budeprion in the middle of October, I was again experiencing some major depressive symptoms as well as dizziness and headaches. I kept with the Budeprion for another four weeks, then discontinued it. The effects began to lift. I started to take St. John’s Wort, which may have helped the depression, but my ADD symptoms remained. In December I resumed Wellbutrin XL (to the tune if $263.74 for three months out of pocket vs the $75 for the generic).
    The therapeutic effects of Wellbutrin XL that I have enjoyed since 1995 have returned.
    The FDA would have me believe that the onset of side effects and depressive symptoms shortly after beginning Budeprion, which abated when it was discontinued, and the therapeutic effects of Wellbutrin XL returning after it’s reinstatement are, just coincidentally, the “natural history” of my depression? What’s wrong with this picture?

  14. BBK
    Reply

    Interesting that we’re worried about generics. Twenty-five years ago an ob-gyn, highly-respected for helping couples have children, prescribed a nine month regimen of birth control pills to treat our 20 year old daughter’s painful endometriosis, reasoning that if the periods stop, the flow stopped, the problem would go away.
    The med was NOT generic. Since our daughter had suffered for years from total lactose intolerance, diagnosed when she was a sophomore in high school, we asked the doctor if there were any possibility that this could be a problem.She could not get the doctor to check on inert ingredients
    Absolutely not. He would not give us a list of inert ingredients and when I asked the pharmacist he said that the doctor was the only one who could get such info.
    During this nine-month period she developed all kinds of problems, headaches, numbness after eating, etc. etc. etc. and all the problems associated with the lactose she thought she was avoiding.
    Finally I wrote the pharmaceutical company. The first item listed: lactose.
    As a result of this she had developed allergies to practically every food known to mankind and was able to eat rice, chicken, garlic, spinach PERIOD for more than a year. She suffered miserably.
    When she explained to the highly lauded doctor’s receptionist the problems she was having, the woman’s indifferent response: Can’t you use OTHER methods of birth control? The doctor would not address the problem.

  15. JAR
    Reply

    The new Budeprion SR 150 has not worked for me either. It is from TEVA and caused side effects of dizziness and a headache. I had my pharmacy get an override to get me back on Bupropion SR 150 (for Welbutrin).
    TEVA has been in business for many years and I don’t blame them. The FDA is responsible for allowing Budeprion to be given for Bupropion. The pharmacy said they are exactly alike but I don’t believe them. The pharmacy said they named them different to help with prescribing medication because one helps a person stop smoking and one helps depression. To believe, I would need to see the ingredients in each one.
    Each foreign and American generics manufacturer should disclose where each ingredient is purchased from and keep the receipt that identifies it with the batch of medicine it is used in. If a problem occurs and is related to any ingredient, that manufacturer could be identified. The public should be aware of where their medicine is coming from for ex Made in China, Made in India, Made in the USA. If it is made in the USA but some ingredients are from China, India or other foreign countries, this should be disclosed. If made in China but some ingredients are made in the USA etc., it should list them. This would make it fair and keep everyone accountable.

  16. hdg
    Reply

    Is there any info as to when/if there will be a generic for Requip available any time soon?
    PEOPLE’S PHARMACY ANSWER:
    Unlikely as it was just recently introduced into the market. If you suffer from restless legs, you may want to search this site for remedies or check out Leg Soap in the store.

  17. jkk
    Reply

    Wow. I had forgotten about the possible negative affects of inactive ingredients in generic medications. I was on Paxil for 7-8 years, then when Sam’s Club got on the bandwagon for $4 prescriptions, I switched with my doctors blessing. All went well for 4 years then bang I hit bottom fast.
    With no reason I went into an abrupt depression. Thank goodness my doctor switch me to EfexorRX and I was weaned in weeks to EfexorRX and was my old self just as quickly.
    I don’t know if they switched manufacturers but suddenly the generic for Paxil was like a depression death sentence. My doctor couldn’t tell me why or what happened but reading Melinda Beck’s article today makes me wonder…jkk

  18. CG
    Reply

    I’m currently taking tizanidine ( generic zanaflex) produced by a pharmacy named Dr Reddy – already sounds suspicious. It doesn’t help my muscle spams. I complained to the dispensing pharmacy but they’re very dismissive.
    I’ve taken other generic zanaflex tablets from other manufactures without a problem. This one seems to less than effective. Maybe out of country manufactures need to be more closely regulated or regulated at all. I guess this will take another trip to my neurologist to get another prescription and have it filled by a local pharmacy.

  19. Sheila Anne
    Reply

    4-22-08 I was watching C-SPAN this morning; the discussion was about this very problem; and it is a BIG one. The quality of generics made in China and India is bad and getting worse.
    The Guest was talking about the years that go by between inspections of manufacturing plants in China. More than 10 years, in some cases. (He mentioned the Blood thinner incidence; he said there were other problems waiting to be discovered.) In one incidence,(the guest said) it was found that the YELLOW color in/on one particular Chinese-made prescription was yellow ROAD PAINT!!!
    My sister almost died from generic Klonopin and the withdrawal symptoms (from using a generic she was told was just as good). Recently,I had to go through days of symptoms because my junker generic atenolol was not working. (I know that it was the junker generics because I went back, found and used a few older ones (in my purse for emergencies) and they worked like always. When I switched to the junkers again, I had rapid heart beats and pounding. IT was horrid! I got a new prescription and this batch seems to be ok.
    sheila anne

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