America loves generic drugs. Anyone who has to pay for medication is thrilled at the prospect of saving big bucks on prescription medicine. That includes insurance companies, hospitals, government agencies like Medicare and Medicaid and lots of patients who pay out of pocket.
The brand name cholesterol-lowering drug Lipitor, for example, can cost more than $200 for a month’s supply. Purchase the generic atorvastatin at some discount drugstores and you might pay just $16. There are even a few supermarket chains offering the drug for free to get customers with prescriptions in the door.
This is a great deal if the generic drug is truly “identical” to its brand name counterpart, as required by law. But do all generic drugs live up to this standard? One manufacturer, Ranbaxy, got into trouble last year because its atorvastatin pills contained particles of glass.
Readers of this column have been sharing their experiences with generic drugs for years. A woman in Humble, TX, reported: “I have been taking Lipitor for nearly four years. I have been taking generic Lipitor since it became available.
“On Lipitor my total cholesterol was 159 mg/dl and LDL 75 mg/dl. After being on atorvastatin for a year at the same dosage, my total cholesterol is 253 and LDL 163. Is it possible that the generic is not as effective?”

The changes in cholesterol numbers are particularly worrisome since the largest increase was in LDL, the fraction of cholesterol that carries the greatest risk for heart health.
Keeping careful records is one way that patients can tell whether their generic drug is doing its job. Another way is to monitor reactions. One woman wrote that her daughter had a seizure while taking the generic antidepressant, Budeprion XL 300. She was convinced that the problem was brought on by the rapid release of the active ingredient bupropion from the pill.
The FDA removed this generic formulation from the market in October, 2012, because it did not meet bioequivalence standards. This is how the agency determines if a generic drug is identical to a brand name.
The trouble with the FDA’s definition of “identical” is that it does not correspond to the way most people understand the word. In everyday terms, identical means exactly alike. The FDA’s definition is much more generous.
A generic drug can differ from the brand name in inactive ingredients (binders, fillers and colors) as well as in the formulation that releases the active ingredient into the body.
Most health professionals assume that generic drugs get into the bloodstream at the same exact rate and in the same amount as the brand. But FDA’s bioequivalence regulations aren’t that strict. Some approved generics get into the bloodstream four to five times faster during the first few hours and fade much more quickly as well.
The FDA assumes that such differences don’t matter, but patient experience suggests otherwise. Recently a person told us that switching from Wellbutrin that had worked for five years to Budeprion left her suicidal within a month. Going back to the brand name “saved her life.” We hope that in the future FDA will change its oversight of generic drugs so that we can all save money without risking our health or our lives.

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  1. kt
    Reply

    America does NOT love generics. We are forced to accept them by greedy insurance companies that refuse to pay for brand names. Believe me if I had a choice I would never choose generic

  2. Nancy
    Reply

    I was put on a beta blocker, TOPROL XL, for premature ventricular palpitations (PVCs) years ago. This drug worked fine for me, with just occasional “break throughs” of the PVCs, until my Medicare Part D switched me to the generic, Metropolol Succinate ER in 2007. I started having more & more PVCs while on the generic, with two episodes so bad they required hospitalization. On discharge, I continued to take the generic Metropolol, with the dosage increased. The increased dosage helped, but I still had enough episodes for me to finally question whether it might be the fault of the generic med., so I requested my pharmacy switch me back to the Brand Name Toprol instead of the generic.
    Within days, my PVCs lessened to just an occasional one. Then, in 3/08 & 12/08 People’s Pharmacy reported on the safety & efficacy of generic TOPROL manufactured by Sandoz/Eon Labs, vindicating my complaints. I still refuse to let my pharmacy fill my Rx with the generic, even though they have switched to a different drug company.

  3. map
    Reply

    I’ve come to distrust generic drugs that are produced in India. I had a situation a few years ago where an infection couldn’t be cured for several months using generic medication that came from a manufacturer in India. I then requested the brand name and within a week I no longer had the infection. I usually check on my prescription bottle the name of the manufacturer of a generic drug and research to see where the drug was produced.
    Most come from reputable companies in the USA but they do have production facilities in foreign countries. I maybe paranoid about this but if I can afford the brand name I will opt for it and I do realize that brand name drugs are produced in foreign countries as well. Lipitor is produced in Ireland and Puerto Rico but I trust Pfizer would have strict quality control measures to assure their brand is what it is.

  4. Maria
    Reply

    I also heard that the active ingredient of a generic drug can vary by 20% or 25%; however, I have not been able to locate a source for this information. Where can I learn more about this allowed variation?

  5. S.l.
    Reply

    How much is your health and quality of life worth to you?? Not much if you purchase generic drugs.
    Have you ever inspected the facilities that these drug are manufactured in ie. India, Asia etc. neither has anybody else and the working conditions and cleanliness are horrible. THINK use your noggin, how do you think these companies make these similar drugs so cheap?

  6. joe h
    Reply

    Problem is that most of us, our medicare and insurance will not pay for a name brand if a generic is available.

  7. Don Y.
    Reply

    I was told by a doctor that a generic drug’s active ingredient could be as low as 20% less effective as the name brand product or as high as 25% more effective than the name brand product and the FDA would consider the products equivalent. That was his reason he refused to put my Mother on a generic warfarin. He said that kind of variance covers too many dosage strengths of Coumadin and that made it too dangerous for her and him.
    Is this variance still in place at the FDA for generic drug approval and could this be the reason how sometimes my generic carisoprodol effectively relieves muscle spasm and other times with a different generic manufacturer, it seems to do nothing at all for my spasms?

  8. Carrie
    Reply

    In my experience with assumptions, I have found assumptions only make an ass out of you and me. And most people have heard that phrase.
    With that being said I’d like to know what brands of meds the members of the FDA along with high members of government and their families take? Do they get the best? Or do they have horror stories too?
    Obviously, the generic cannot be identical, or it would be like me making the exact same product and putting my name on it. Something has to be different. Similar to buying a generic food product, something always tastes, looks, and smells different, sometimes for the better sometimes not.
    I don’t know anything about how much it costs to manufacture these medications. But these are serious issues and they have me asking what makes the generic so much cheaper then the name brand? Is it the formulation that releases the active ingredient into the body? Is it the binders, fillers, or colours? Is it the active ingredient? Or is it just the name on the bottle that determines the price? Because if these ingredients and their processes don’t cost that much then perhaps it is wise for the FDA to take control. Maybe they could allow generic medication producers to change only colour and shape, and maybe a filler or two if it doesn’t hamper with bioequivalence ratios.
    But some take accountability and do their job would be nice for a change. Protect the consumer, and stop protecting rich man’s pocket book. There I said it. :-)

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