For years, the FDA has reassured everyone who prescribes, dispenses or pays for prescription medicine that generic drugs are absolutely equivalent to brand-name drugs. Because brand name medications are so expensive, most people embrace the opportunity to save money.

If generic fluoxetine is only $4 per month at a discount drug store while brand name Prozac costs $175 for a month’s supply at a neighborhood pharmacy, it is understandable why consumers would opt for the cheaper generic.

Insurance companies are enthusiastic about generic drugs. They encourage patients to accept generic prescriptions by lowering the co-payment for these medicines and raising it for brand names. They may even refuse to pay for certain brand-name products.

But are generic drugs truly identical to their brand-name counterparts? Patients, physicians, pharmacists, nurses, hospitals and insurance companies all depend on the FDA to ensure that generic drugs will work just like the originals.

We used to recommend generic drugs as a great way to save money. We were convinced that the FDA had a rigorous approval process.

Several years ago, however, we began getting reports from readers of this column that their generic medicines weren’t always working as expected. We heard from people who suddenly experienced seizures after being switched from the brand-name epilepsy drug Dilantin to the generic phenytoin. Others reported problems with the generic blood-thinner warfarin when it was substituted for Coumadin.

An avalanche of complaints started last year, from patients reporting problems with the generic antidepressant Budeprion XL 300. Many had had their depression well controlled while taking the brand Wellbutrin XL 300 (bupropion). On the generic formulation, however, they reported side effects such as agitation, anxiety, nausea, headache and insomnia.

Patients taking the generic frequently reported feelings of despair, hopelessness and depression. Some said they started crying for no apparent reason and others described thoughts of suicide occurring for the first time.

We forwarded many of these reports to the FDA and asked the agency to investigate. The report is now in and the FDA has announced that everything is fine with generic Budeprion XL 300 mg. Or is it?

The FDA appears to explain the return of depression on Budeprion XL 300 as a natural recurrence of depression. Oddly, relatively few people have complained about depression recurring on other generic formulations of bupropion.

We had always assumed that all generic products were tested before approval. To our surprise, the FDA revealed that it did not require tests on Budeprion XL 300. The generic manufacturer submitted data for a 150 mg formulation, not a 300 mg tablet. Based on the data, the agency approved Budeprion XL 300.

Even the 150 mg formulation differs noticeably from the brand name in the way in which it enters the blood stream. The FDA says it doesn’t think this matters. We disagree, and hundreds of readers seem to as well.

Anyone who would like to report a problem with a medication may do so at www.peoplespharmacy.com. We will pass your information along to the FDA. To report directly to the agency go to www.FDA.gov/MedWatch.

 

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  1. LK
    Reply

    I am hoping that the studies are continuing… This Generic Wellbutrin XL IS NOT WORKING for me! After 4 months… back to depression.

  2. Pumba
    Reply

    I had been prescribed Buproprion XL 150mg, and my insurance company substituted Budeprion XL 150 mg. I and everyone else around me noticed that I had become very lethargic — I slept about 14 hours a day. Not good! This co-supports much of the other comments posted here.

  3. vlk
    Reply

    I had been taking fluexotine and buproprion SR for depression/anxiety for many years with wonderful results. Since both were generic I had no issues with my insurance coverage or the cost.
    A few months ago I decided to switch from Kroger pharmacy to my insurance companies mail-order pharmacy since I could save a little more money (yearly) and have three months of RXs mailed to my home with little trouble.
    Without my consent or knowledge, my insurance company (Cigna) switched my Buproprion SR 150 mg for Budeprion SR 150 mg. After only a week, I started having horrible insomnia, panic attacks, restless leg syndrome, and gastrointestinal problems. I went to my Dr. and neither of us could figure out what the cause was. After trying every possible medication and then herbal remedy either of us could think of, it occurred to me to look at my Rx’s. Then I found that the switch had happened and my doctor said that was THE culprit all along. I immediately contacted my insurance company and was told that the switch was completely reasonable and I would “get over” the symptoms after a few weeks adjustment. By that time, I hadn’t slept in four days and was in agony! How was I supposed to survive a few more weeks!
    My insurance REFUSED even after hearing from my doctor to provide me with Buproprion SR. Now they say that even if I dropped the mail order pharmacy and went back to Kroger…they’ll refuse to cover it! So, my only choice has been to stop taking the budeprion and double my Fluexotine (generic for Prozac). Since doing that, ALL of my previously mentioned problems have completely and quickly disappeared.
    There IS a HUGE difference between Budeprion SR and Buproprion SR! Considering the horrible side effects, Budeprion SR should be pulled from the market. Also, there should be laws put in place to keep insurance companies from playing doctor. They have NO RIGHT to switch a patients medications without the patient and doctor’s consent! They’re playing with people’s health and well-being! Allowing them to do so is like handing a monkey a loaded gun and being surprised when it kills somebody!

  4. JSmith
    Reply

    Although extremely frustrated with the drug company & my insurance company, I feel validated after reading articles & what people have written on yours & others sites concerning the generics Budeprion XL 150mg & Buproprion XL 150mg. I have been on Wellbutrin for over 10yrs for Dysthymia. I was on Wellbutrin SR 150mg bid until my insurance company decided to bump it up to a tier 3 (extremely expensive). Being very money conscious & believing in most generics, I switched to the Buproprion SR 150s & within a few weeks was extremely irritable, crying all the time, couldn’t focus, lethargic, etc.
    My doctor & I requested brand, only to be told I could have it, but I would have to pay the outrageous difference in cost, which I couldn’t afford.
    My doctor then switched me to brand Wellbutrin XL 150mg-it had recently come out. It was a tier 2 & we thought it might work for me. We found that I had to go from taking 300mg of the SR to 450mg of the XL, but that seemed to do the trick. Life seemed good again.
    But wait, here comes the drug company a year or so later (mid 2008) saying they are now changing the Wellbutrin XL 150mg to a tier 3 & I would need to get the generic or pay the difference (between $247-$656 for a 90 day supply depending on the day you order) between the generic & the brand if it is wanted/required. I didn’t worry about this immediately as I had another refills on my RX & thought this would go into effect once I sent in a new RX.
    August 2008: Had to get a month’s worth of Wellbutrin XL 150mg filled at a local pharmacy while waiting for mail order. When picked it up noticed it read Budeprion XL 150mg tid. Thought they had misspelled Buproprion not knowing there was a generic called Budeprion. Past that, didn’t think much of it. Became physically very sick, missing 5 days of work. Went to the doctor’s x2, had 2 MRIs (1 of Kidney, Spleen, & upper abdomen/stomach area, 1 of liver and lower abdomen area). I had diarrhea, severe headache, blurred vision, fatigue, muscle weakness, aches, & tremors, was nauseated, dizzy, and had pain in my left side (flank) and my entire mid section, and felt bloated. It was awful.
    I didn’t know what was wrong with me. My doctor & I tried to figure out if I had eaten or drank something bad/toxic, etc. While at home trying to feel better I began thinking of when these symptoms began & it seemed to be within a day or two of first taking the new RX, Budeprion XL 150mg. I couldn’t imagine that could be it, but thought it would be worth stopping to see if my symptoms abated. Within in 3 days of not taking the Budeprion XL I was symptom free.
    Now the problem was getting the brand Wellbutrin XL 150mg and that’s when I began paying $247-$656+ which is my co-pay + 20% of the difference in brand and generic for a 90 day supply. My insurance company insists the generic is the same as the brand. Even when my doctor sends in the prior authorization and Med Watch form indicating the medical necessity for me to have brand it’s on me for the cost.
    If a medication is inferior or a health hazard, and it’s been proven, I should not be forced to use the generic nor forced to pay the higher cost because I need brand (per medical necessity).
    Why is Budeprion XL, specifically the TEVA brand still on the market? It’s harming a lot of people. What can I do to help alleviate my cost when it truly is medically necessary that I have the brand of Wellbutrin XL or SR if I could go back?

  5. VS
    Reply

    For what it’s worth, I’ve worked with people with tactile hallucinations. Having seen how awful that can be for the people suffering them, I wish you, MER, the best of luck with getting your daughters symptoms under control. It is one thing to hear voices, but a much more compelling violation to actually perceive physical violation of the body.

  6. mer
    Reply

    My daughter, diagnosed with Schizoaffective Disorder, was originally taking Clozaril. When the generic form Clozapine became available, she was automatically prescribed that. As with other drugs, the cost difference is substantial, but possibly moreso because regular lab monitoring is a firm requirement while on either drug, thus increasing the cost. Over time I felt her symptoms became worse when on the Clozapine, specifically paranoia and tactile hallucinations. She has been put back on Clozaril at her family’s request, and we feel she is improving symptomatically, although more time will tell. I would like to ask for comment by others who have taken both of these two drugs, regarding effectiveness.

  7. LK
    Reply

    Generic drugs are required to be 80% as efficacious as brand name drugs (although pharmacists will disagree with you because they make big money off generics). My question is do you want your birth control pill to only work 80% of the time???

  8. Sheila Anne
    Reply

    Peoples’ Pharmacy asks,”But are generic drugs truly identical to their brand-name counterparts?”
    I (and friends and family) reply,” no, no, no, no, no, no, NO, NO!!!!!!!!!.”

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