For decades the FDA has reassured physicians, pharmacists and patients that generic drugs are identical to their brand name counterparts. Insurance companies love this guarantee. They often require patients to switch to a low-cost generic if any are available.

In an unexpected about-face, however, one of the FDA’s top administrators has admitted that there may be problems with some generic drugs. Janet Woodcock, MD, is Director of the FDA’s Center for Drug Evaluation and Research. She spoke recently to the Generic Pharmaceutical Association, a trade group that represents many of the biggest generic drug companies.

Dr. Woodcock said, “I’ve heard it enough times from enough people to believe that there are a few products that aren’t meeting quality standards. They say, ‘I know there are products out there that aren’t equivalent,’ and typically they’re manufacturing folks.”

In other words, employees at generic drug firms have whispered in Dr. Woodcock’s ear about their own concerns regarding quality control. We too have heard from insiders about their fears: “I once worked for a pharmaceutical company that ordered a raw ingredient from China. That ingredient was diphenhydramine [an antihistamine found in allergy medicine and many OTC sleeping pills].

“I was a quality assurance inspector and had to inspect incoming material. That ingredient was so trashy with what looked like a lot of floor sweepings–black blobs of something I could not identify. I placed the ingredient on reject. The next day the boss told me that he had authorized the release of that ingredient to be used in production!

“When I left work later that day I called the FDA and reported the whole thing. I don’t know if the FDA acted on my complaint but I called in the next day and quit my job.”

Many consumers also have doubts. They have told their stories on our website (www.peoplespharmacy.com).
Here is one: “I took Keppra for epilepsy. In January 2009 I was given generic Keppra.

“I felt sick to my stomach and had multiple seizures. My neurologist told me to stay on the brand med and even wrote ‘brand necessary’ on the script, but the insurance company refused and gave me generic.

“I had seizures for five weeks before they allowed me to go back on the brand. My blood level on the generic was much lower than on the brand and I found the generic was not as effective.”

Sometimes switching from one generic to another produces problems. A reader reported doing well on generic Wellbutrin (bupropion) for depression: “My local pharmacy filled the original prescription with little round blue pills. When it came time to refill the prescription, I received yellow oblong tablets. Within 24 hours I experienced high anxiety and nausea. I had never felt either of these side effects with the blue bupropion tablets.”

Having acknowledged that there is a problem, the FDA appears poised to tighten standards on certain generic drugs such as anticoagulants, anti-seizure medicines, some antidepressants and medications to regulate heart rhythms. If you have experienced a problem with a generic drug bring it to the FDA’s attention: www.fda.gov/medwatch.

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  1. Greg Pharmacy Student
    Reply

    MS,
    Where can you do online research to see if the new pills are ok to take? If you found a site that talks about those specific pills or that specific manufacturer is it possible to determine if the pills you have are the same lot or made at the same time as the ones mentioned? Is it possible to determine if the site you found information about the pills is unbiased? Couldn’t competing manufacturers fabricate quality issues as a way to boost their own sales?
    Let me know if you have found answers to any of your questions or mine.

  2. MS
    Reply

    I also just got the little blue pills marked “E 410”. This is my first refill and the initial prescription pills were lavender and slightly larger. They worked really well. I am worried about these different pills and I am doing online research today to make sure they are okay to take.

  3. Jesse
    Reply

    I word of warning about Cozaar generic, losartin. For several years I have taken Cozaar and then the generic and my b/p was always well controlled. Two weeks ago I got a refill, but at a new place, Costco, and the generic was white, not green, and by a generic company I’d never had before, Zydus.
    The pharmacist said it was indeed losartin. After about a week, I began having dizzy spells. At a store I had to hold on to a counter and then I slid onto the floor. The dizzy spells got worse, my head felt as though it would explode and there was loud ringing in my ears. When I lay down I was dizzy and felt pressure in my head. I could not sleep The next day it was worse. I took my b/p and it was 186/118.
    Called the cardiologist and she said to go back on the brand name Cozaar I still had on hand and increase the dose and to take 25 mg. diuretic (HCTZ). Because my b/p is always stable she said she believed it was the generic Zydus losartin.
    It took about 14 hours, but my b/p stabilized. But I still feel weak and that is to be expected after what happened. The cardio dr. did an EKG today and it was normal. Now I am wearing a 24 hr. Holter monitor. The cardio dr. says never take Zydus losartin again.
    Be very carful about taking drugs. With each refill or new prescription pay strict attention to see if the drug is working or causing problems.
    I could have had a stroke and died if I had kept taking the Zydus generic losartin.
    Jesse.

  4. avl
    Reply

    I have taken the generic for wellbutrin by teva labs got negative results. Symptoms included blurred vision, dizziness, twitching, I felt on edge and snapped at everybody also I gained weight so quickly and that just added to my depression. When I got my refill it was a little blue pill with the marking E 410, by Eon labs. Does anyone have any feedback on this brand? Can anyone tell me what is the best generic for wellbutrin? If there is any.

  5. Helen
    Reply

    A generic version of Xalatan eye drops used to prevent high eye pressure is now available. I had been using the brand name for several years. Since the brand name is very expensive I opted to try the new generic made by APOTEX. I used them twice and awoke with very hazy vision which took 1 to 2 hours to clear. My eyes were extremely bloodshot and irritated. I stopped the drops but still have irritation and have to use warm packs on my eyes several times a day. I hope you will watch for other readers to report on the new generic.

  6. Jesse
    Reply

    Have others had problems when switched by insurance company from Cozaar to generic (losartin) by Roxane Labs? If so, what problems?
    Thanks

  7. beau10
    Reply

    The comments with this article mirrors comments from many people I know who have had generics. My aunt was prescribed a generic that darned near killed her. Her doctor got on the phone with the insurance and threatened the reps with really nasty consequences if she were not switched back to the original – that worked.
    I believe the FDA does not represent us, the ordinary citizen, but is not much more than a hand-puppet for Big Pharma. I think we really don’t have much protection provided by the FDA and are pretty much just on our own.

  8. sam
    Reply

    A new forecast suggests that generic medicines may also increase their market control, accounting for about 85% of prescriptions by 2014. About half of the patients who were diagnosed of a major chronic condition were prescribed a generic medication in the past two years.

  9. Greg Pharmacy Student
    Reply

    P Rick,
    Maybe generics shouldn’t be allowed at all. A lot of choices and consequences surround this brand name / generic issue.
    This whole issue would be less complicated if the consumer and not the government or an insurance company paid for medications.
    Prescription medication insurance is relatively new compared to medical insurance.
    Everyone keep in mind that by taking medications regularly and as prescribed your overall health care costs are DECREASED, while of course medication costs increase.
    In general drugs are BAD, but disease and being in the hospital is much worse.

  10. P Rick
    Reply

    P Rick nov 10 2010
    I have to buy into the medicare Part D drug program to get my meds. It’s a shame that most of these programs charge so much more for Brand name drugs. And some won’t even cover them unless one pays a very high premium each month and then a much higher cost at the counter!
    The generics are definitely being pushed down our throats! I have had so many bad experiences with generics and I mean bad reactions that my MD said i must stay on the Brand name drugs in order to get the same quality each time.
    But gosh, I sure do have to pay in order to be assured of safety in medications.
    Does not seem fair nor medically ethical.

  11. Jessica
    Reply

    Last week, my doctor ordered my prescriptions to be “brand only.” My doctor has written my prescriptions this way for over four years. My local pharmacy and MEDCO have noted my medication preferences in my profile. Upon receiving these recent prescriptions, MEDCO ignored my doctor’s written orders and called the practice and apparently spoke to another doctor in the practice.
    This doctor (who we all know it was an administrator not the doctor) approved the switch to generic. I received my new medications yesterday with a letter stating it was all in an effort to save me money. Frankly, isn’t it to save MEDCO money?
    I understand, cost is a big concern but so is efficacy. Which medications are the most effective is between me and my personal physician- not MEDCO. I am writing a formal letter of complaint.

  12. Dolores
    Reply

    I have been telling my doctor and pharmacist about the generic drugs ever since the insurance company said I must change. I, too, had trouble with generic Allegra. My eye doctor told me to switch to over the counter Claritin. So far OK.
    I’ve had trouble when the pharmacist changed the company or source the generic came from. They keep telling me they are the same as the name brand. The doctor did write the insurance company about the Synthroid. He did not want the generic and neither did I. It doesn’t work the same. I must always check the prescriptions each time I get them to at least make sure they’re the same generic. What has to happen–people start dying or are irreversibly damaged?

  13. charlotte
    Reply

    “A Ranbaxy factory in New York failed an FDA inspection because it made diabetes and antacid medicines with “black particles” and “cardboard” floating in it, and ignored anomalous testing results in its laudanum product, which it was selling without FDA approval.
    It’s the latest in a series of screwups at the disaster-prone company. The FDA previously accused Ranbaxy of faking test data, two of its Indian factories are banned from exporting products to the U.S. for manufacturing failures, and it twice recalled lots of acne medication last year”
    AT:
    http://www.bnet.com/blog/drug-business/ranbaxy-8217s-reign-of-error-continues-as-fda-flunks-its-new-york-drug-factory/4255e
    We should name and shame these companies.I will not have any medication from Ranbaxy.
    I will not eat or drink ANYTHING from China since the Melamine in Milk scandal, the Heparin scandal.

  14. Paul43
    Reply

    I was just in a big argument with a good friend of mine over the quality of Generic vs Brand name— I like to hear more on this subject.
    Does anyone know where these BRAND or GENERIC drugs are manufactured?

  15. Jan S.
    Reply

    I did so well on Cozaar for blood pressure for years. MEDCO sent new generic, insisting it was the same, made by same co., just color change. I had almost fainting weak spells- brain CT, etc. were ok, so realized it was the generic. I take half at noon and half at bedtime and after a couple weeks, finally pretty good but not as good as before. Don’t tell ME they are the same; I have to have brand name Cardizem as generic sent me to clinic after 1 pill. Aren’t generics from competitors- why would same co. make the generic? Hmmm.

  16. Kathy
    Reply

    I have been taking synthroid for over 20 years. Several years ago, I was encouraged by my health plan to switch to the generic. When I did so, my test results became erratic and the doctor had to keep testing – and changing my dosage (which I believe was more expensive than just sticking with the synthroid). Since returning to synthroid, I have had no problems. I have heard several doctors say that synthroid is one of the few medications for which a generic should NOT be considered. Can you comment please?

  17. DWD
    Reply

    Yet some in this country believe we are over regulated.
    “The next day the boss told me that he had authorized the release of that ingredient to be used in production!”
    With bosses like this, we won’t need the new health plan’s “death squads”.
    Gee, think of all the waste and fraud that will be eliminated with less regulation.
    Warning, the above contains 100% of the MDR of sarcasm.

  18. allieb
    Reply

    In August of 2006 after my husband had emergency surgery, a few days later I awoke with a fuzzy eye. I went to my eye care center and was diagnosed with Iritis (caused by the chicken pox virus) following great stress or a jolt to the body (such as a car accident). I was placed on Famvir and Pred Forte Drops. When I had the prescription filled, a generic drug was used for the Famvir.
    Not knowing much about medicines, I did not know the difference. For a year the virus cells in my eye never changed until my doctor looked at my medication and saw that it was the generic brand. He wrote a new prescription and noted “Do Not Substitute”. As I was going to him every few weeks, he began to notice a drop in the number of live cells in my eye.
    Now all my prescriptions read ” Do Not Substitute”. I now know generics do not work for me. I don’t care what the drug manufacturers say or the doctors- generic drugs are not the same as the name brand.

  19. cpmt
    Reply

    I had problems with several medications. the generic ALLEGRA doesn’t work for me. I also had problems (urine smell and taste) with Metformin. My husband had problems with a lowering HBP medication (smelly etc.) He stopped taking it.

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