There was a time when most of the prescriptions filled in America were for branded drugs. Valium, Prozac and Lipitor were household names.
Now, the vast majority of prescriptions are filled with generic equivalents. The names are frequently tongue twisters. Diazepam, fluoxetine and atorvastatin are not as easily pronounced or remembered as their brand names were.
The Food and Drug Administration has maintained for decades that generic drugs are identical to their brand name counterparts. That is why insurance companies and other payers often refuse to pay for a brand name pill.
Now, the FDA is reevaluating its position on generics, especially those designed to release their ingredients slowly. This is partly a result of People’s Pharmacy readers reporting their difficulties with a long-acting formulation of the antidepressant bupropion.
Shortly after the generic drug Budeprion XL 300 was introduced, some people who had taken the brand-name Wellbutrin XL 300 started telling us that the generic was not working the same. We passed these reports on to the FDA. Eventually the agency conducted its own study to see whether Budeprion XL 300 got into the system the same way as Wellbutrin XL 300. When it did not, the FDA asked the manufacturer to remove this antidepressant from the market.
This has prompted a change in policy, according to Gregory Geba, MD, MPH, director of the Office of Generic Drugs. Extended release formulations are often indicated by abbreviations like CD, CR, ER, LA, SR, XL, XR and XT. There are hundreds of such products because they are more convenient than medications taken two or three times a day.
Most people don’t realize that the technologies that allow for slow release of ingredients may differ between the brand and the generic versions. That’s because the formulation that allows for slow release can be under a separate patent from the active drug ingredient.
To release the medicine in a controlled manner, manufacturers have developed sophisticated coatings, laser-cut holes or special pelleting processes. The generic manufacturer may not have permission to use the same technique. Substituting a different type of slow-release approach, as was the case with Budeprion XL 300, may change the way the drug gets into the bloodstream.
Now that the FDA has come to grips with this potential problem, it appears to be raising the bar for generic manufacturing going forward. Questions remain, however, about the performance of some generic drugs approved under the old guidelines.
Many readers have reported problems with slow-release generics: “I was on Toprol-XL after heart bypass several months ago. My systolic blood pressure was perfect at around 120. When I was switched to generic metoprolol my blood pressure went to the 170 range.” Others have noted irregular heart rhythms on generic metoprolol but not on Toprol-XL.
Here are some other scary stories:
++++++++++++++++++++
“My husband has been on Keppra for two years. After receiving the generic Keppra prescription levetiracetam he has been having seizures on a daily basis. We are now scheduled with a seizure specialist because of this new situation. This has only began since introduced to the generic Keppra. I am very concerned. Is this being reported in the news?”
Denise
++++++++++++++++++++
“I want to report a serious problem with a generic drug. Is there a specific place to report it or should I just use the FDA adverse event form? Is there only one form? It seems designed for people who have been injured. What if you just want to report that a generic drug was completely different from the brand?
My problem was with sertraline (generic for Zoloft). It caused me to go into abrupt total SSRI withdrawal like I had taken nothing. So I was injured but not in the way that the FDA form seems designed for. After they finally admitted to SSRI withdrawal effects and added the “discontinuation syndrome” warning, it’s ironic that the failure of the generic caused me to go into sudden, unintended withdrawal. It was very scary!”

Becca
++++++++++++++++++++
The FDA has not made it easy to report generic drug failures. And it is unclear whether the agency has committed staff to the exclusive job of tracking down these generic drug problems. Rarely, if ever, does the FDA follow-up with patients, physicians or pharmacists who report that a generic drug failed. For years the FDA denied that there could even be a problem.
We do NOT want to discourage the use of generic drugs. They make up roughly 80% of all drugs dispensed these days and they save us a ton of money. We do want the FDA to take reports of generic drug failures more seriously. We also want doctors and pharmacists to believe patients when they report serious problems with generic drugs. And we want insurance companies to stop falling back on the claim that all generic drugs are identical to their brand name counterparts. We now know that is not always true! Finally, we want the FDA to monitor generic drug manufacturing better and make sure there is improved quality control. Random testing of products off pharmacy shelves would be a good start. The honor system that currently exists just isn’t working.
To learn how to report problems and use generic drugs safely, you may find our “Top 10 Tips for Taking Generic Drugs” helpful. They are in our book, Top Screwups Doctors Make and How to Avoid Them, available in libraries, bookstores and online at PeoplesPharmacy.com.

Join Over 52,000 Subscribers at The People's Pharmacy

  1. Ernestine
    Reply

    I just tried to get a refill for my husband s lovoquin 500 mg. He takes three pills a month during catheter change time. I used to get the real brand and was glad to pay the price, then the pharmacy insisted the generic was the same. Now today, I get a refill, and it is different color and different shape, and it is from India. I refuse to give it to my husband. He said he did not have the manufacturer but FDA has approved them, well I am not going to take a chance on my 90 yo husband who wears a permanent catheter and does not need to get infections. I will ask my doctor tomorrow to give new prescription for no generic. Atleast the other generic was same shape and color, I am not going to take a chance on this. Fed up.
    Ernestine

  2. PC
    Reply

    I too, think I have better blood pressure with brand names and I’m not 100% comfortable with gen. lipitor. My problem is my insurance only pays 40% of brand names which would make lipitor $60.00 a month, but they pay 90% of generic. Insurance companies should not penalize you for wanting brand name drugs.

  3. robert
    Reply

    I hope there will also be more focus on the excipients (fillers), they seem sometimes causes of trouble with generics.

  4. Dr Bob
    Reply

    The fallacy of generic equivalence is recognized by those of us in practice in the community. while the FDA requires that the generic manufacturer “must show” that the generic drug “bioequivalent” to the brand name drug. “Bioequivalence” is demonstrated by measuring the time that it takes the generic drug to reach the blood stream and its concentration in 24-36 healthy, normal volunteers.
    I find this “testing” strategy statistically incompetent. The FDA then requires that the generic manufacturer “must assure” the FDA that the raw materials and the finished product meet USP specifications. The manufacturer must provide a full description of the manufacturing facilities and “certify” that it complies with federal regulations about current good manufacturing practices, and must undergo inspection of the facility to ensure compliance.
    I am unable to locate the criteria and allowable variance in the absorption and blood level measurements on the FDA website. Nor am I able to determine the frequency with which the FDA conducts manufacturing establishment inspections after initial approval is obtained.
    The recent withdrawal of the generic bupropion product Budeprion from the market due to failed quality control is no surprise. My patients experience generic failure or toxicity when switched from branded products to generic product or switched from one generic manufacturer to another on a frequency of about once per month.
    Personally, I have experienced generic drug failure in my personal medication prescriptions as well. When using generic medication, I request that the pharmacy refill it from the same manufacturer consistently. My pharmacy has been most cooperative in these requests. I advise my patients to do the same.
    From my review of the medical literature, medications with a narrow therapeutic window; i.e., requiring carefully titrated dosages such as anticonvulsants (medications for the treatment of epilepsy) have about a 15-20% failure rate when switching from branded to generic formulations or switching between generic manufacturers.
    It is estimated that there are 3500 pharmaceutical manufacturing sites supplying medications to the United States. I am unable to locate any information about the re-inspection frequency by the FDA. I am unable to locate any mention of bioequivalence retesting after generic drug approval.
    The rationale for the use of generic medications is based on cost. “Lower cost to the consumer!” But at what cost? There is no mention of the massive profit margin to be obtained by the manufacture and sale of generic drugs. I must believe that the margins are significant when there are several manufacturers for the same medication. for example, when I last counted, there were 22 generic manufacturers for generic lamotrigine.
    The competition for retail sales must be intense. I must assume that competition for retail generic placement is based on cost. How can costs be controlled in a continually challenging competitive environment? After the initial investment for facilities, the costs of labor, raw materials, and processing are the variables. What do you cut to maintain or increase market share?
    A very wise man once said to me, “Yes, I personally use generic medications. I use them for everything except for my brain and my heart.”

  5. JimP
    Reply

    My wife found a difference between two generic drug manufacturers in regards to pramipexole (generic Mirapex). After an Rx refill in Spring, 2012, she found that her restless leg syndrome wasn’t being controlled on one out of every three evenings. It turned out that our pharmacy had switched manufacturers of pramipexole. After several weeks of misery, our pharmacy ordered pramipexole from a different generic manufacturer (Sandoz). Now her RLS is back under control.
    I take generic Flomax for BPH. Over the last year, my condition seemed to worsen with more urgent urination and waking up every 2-3 hours at night to urinate. I found some leftover samples of brand-name Flomax that I took for 2 weeks. My problems greatly diminished and I even sometimes slept through the night. I started back on my generic Flomax 2 days ago, and last night I was up every two hours to urinate! I’ll have to see if the pharmacy will order the generic from a different manufacturer.

  6. Leon
    Reply

    What was not mentioned in the above article was the difference in Narrow Therapeutic Index drugs and generics. Since NTI drugs are dosed in micrograms instead of milograms, slight dose variances could lead to a higher or lower dose that would be totally different than the innovator brand name drug. Examples would be Synthroid and Digoxin. Since the FDA allows generics to fluctuate + or – 20% of the Brand name drug, a generic substitution could vary downward or upward to a different therapeutic dose, resulting in too much or too little drug to maintain consistent therapeutic blood levels.

  7. Mary D.
    Reply

    Is there a patient’s Bill of Rights with pharmacies? I know that state and federal law guides many procedures. It seems that drug counseling should happen before a patient pays for the med.
    I can’t prove that I argued with 3 pharmacists when they gave me the wrong med. They all lied and said it was the very same med that I had been taking. It wasn’t and I became very ill.
    Part of the problem was that they bagged the med and brought it to the counter. My doctor got after them for that. Since then, I’ve been in line, where they showed each med to a customer, and the customers said they were happy with the new procedure, as they never really knew what they got until they opened the bag outside.
    My doctor asked me to change pharmacies, but I use Librax, and I can’t get it anywhere else. I called Walmart-and they said they wouldn’t carry it.
    Thank you

  8. bd
    Reply

    The FDA must eventually address the differences that exist between generic and name brand drugs. Not only is the long acting formulation different between the two, but the inert ingredients are different and impacting as well.
    I had an allergic reaction when changing from the name brand to a generic anti-depressant. It was determined I was allergic to one of the inert ingredients in the generic. As an asthmatic I also take oral prednisone and albuterol frequently which requires a corresponding dose of Xanax to control the rapid pulse, etc.
    The generic form of Xanax reacts totally differently than the brand name both in speed of action and side effects, yet my insurance company will only provide the generic version. The FDA must break their denial of the differences between generic and name brand.

  9. J.L.B.
    Reply

    I had a bad experience with a change of generic manufacturers of a generic blood pressure drug (diltiazem). I took the drug at night. When the pharmacy changed the generic manufacturer from Teva to Andrx consequently my morning blood systolic pressure jumped 30 to 40 points which was a dangerous increase.
    Only when I showed the pharmacist my daily morning blood pressure readings which clearly showed a drastic blood pressure increase was I able to convince the pharmacist that the capsules made by Andrx were not working and then she (pharmacist) ordered the medication from Teva and then my morning blood pressure returned to normal.
    I don’t know why the Andrx capsules did not work but there had to be some problem with the source of the active ingredient.

  10. Paul 43
    Reply

    I would like to hear more about this

  11. Martha
    Reply

    I am on toprol 50mg and when it went generic they had to up it to 100mg. Generic is not the same as the real thing.

What Do You Think?

Share your thoughts with others, but be mindful of protecting your own and others' privacy. Not all comments will be posted. Advice from web visitors is not a substitute for medical attention. Do not stop any medicine without checking with the prescriber. In posting a comment, you agree to our commenting policy and website terms and conditions.