safety concerns

In the field of pharmaceuticals, Americans have been told that price doesn’t matter. Generic drugs are supposed to be identical to their brand name counterparts. For nearly 30 years, we believed this argument. We encouraged people to save money by insisting that their physicians prescribe generics whenever they were available.

The Original People’s Pharmacy Book:

A lot of health professionals and FDA officials who are familiar with our work find it hard to believe that Joe was once among the country’s leading advocates for generic drugs. The People’s Pharmacy book was first published in 1976. In it Joe had a chapter titled “How to Save Money on Prescription Drugs.” Here is what he wrote almost 40 years ago:

“The argument which your doctor will almost always resort to when defending his practice of prescribing expensive brands is that they are superior in quality to the el cheapo generic varieties. Since no one wants a prescription for lousy medicine, this approach usually shuts a patient up pretty fast. By the time the doctor is finished, you will probably apologize for mentioning the subject and end up meekly retreating with your tail between your legs. But does this argument hold water?

“Now just so you know which side of the fence I am on I am going to make the story crystal clear. If your doctors hands you this tired line, he is fooling you in the worst way. The inequality of drugs routine is usually just plain untrue. Although there have been some exceptions, there is very little solid evidence that demonstrates generic drugs to be inferior. But don’t take my word for it: listen to what the experts have to say.

“Let’s start with antibiotics, because they are prescribed with great regularity. That is where your doctor is on the thinnest ice if he tries to convince you that expensive brand-name drugs are more reliable than generic equivalents. For one thing, the Food and Drug Administration tests and certifies each batch of antibiotic for all pharmaceutical manufacturers before any product can be released for market…”

Our BIG U Turn!

We believe that what Joe wrote 40 years ago was true…then. But how times have changed. The FDA no longer tests or certifies each batch of antibiotics or anything else for that matter. For the most part the FDA relies on the honor system. Drug companies are responsible for their own testing and quality control. Now that most of our generic drugs are made in foreign countries, we  have relied on regulators in those countries to oversee a lot of the generic drug manufacturing process.

In the last few years, however, the FDA has discovered that its trust may have been misplaced. Since sending a handful of FDA inspectors to India an incredible number of cases of fraud and poor manufacturing have been discovered. Reuters reported on Sept. 14, 2015:

“The ban on Polydrug takes the total number of Indian drug manufacturing facilities that currently stand barred from exporting to the United States to 44 between 2011 and now, according to the FDA website.

“The sanctions have hurt India’s image as a reliable supplier of cheap generics, and slowed the growth of India’s $15 billion pharmaceutical industry that supplies 40 percent of the generic and over-the-counter medicines sold in the United States.”

How We Learned There Was a Problem:

Our faith in the FDA was challenged several years ago when some pharmacists started telling us they had doubts about the quality of certain generic products. We also began getting letters from readers who had trouble with their generic prescriptions. Readers have shared their disappointment with generic pain relievers, antidepressants, blood pressure medicines and diabetes drugs. The generic drug manufacturers discount these reports.

Kathleen Jaeger, president and ceo of the Generic Pharmaceutical Association, has written:

“To set the record straight, there are no differences between FDA-approved brand and generic medicines. A generic must meet the same high standards as the brand-name drug, with the same safety and effectiveness, same active ingredients, same strength and dosage, same labeling and use and same high quality manufacturing standards.”

While we agree with Ms. Jaeger that FDA approval is rigorous, it is not foolproof. We proved that we we uncovered problems with the FDA’s approval of the generic version of the antidepressant Wellbutrin XL 300. After years of fighting the FDA it was revealed that Budeprion XL 300 (a generic version of bupropion) was not up to snuff. A couple of other generic versions of bupropion were also found lacking.

We also worry that once drugs are approved and marketed, monitoring is spotty at best. The FDA is not capable of analyzing more than a handful of pill bottles from pharmacy shelves each year. As a result, unscrupulous manufacturers or counterfeiters may be slipping substandard generics into the marketplace.

How to Report a Generic Drug Problem:

Let’s start with the FDA unwavering position that there are no (read that zero, nada, zip) problems with generic drugs. The agency still maintains that everything is fine and dandy with its approval process and its monitoring of foreign drug making despite banning 44 manufacturing facilities from exporting drugs to the U.S.

That said, the FDA repeatedly tells us that it wants patients to report a generic drug problem through its MedWatch system. Of course the FDA makes it very hard to report a generic drug problem this way. That’s because it requires information that is really hard to obtain:

  1. Manufacturer/Labeler (pharmacies do not always put this information on the label, or if they do it is often in print so tiny that it is very hard to read)
  2. Expiration date (pharmacies almost never put the actual expiration date on the label. They are not required to do so and it would be almost a miracle if they did. What they do put on the label is the discard date, which is almost always one year to the day the drug was dispensed. It has no relationship to the expiration date)
  3. Lot Number (pharmacies rarely, if ever, put the lot number on a dispensed bottle of a generic medicine. Unless the pharmacist dispenses the original bottle from the manufacturer you will have no way of determining the lot number unless you call the pharmacist)
  4. NDC # (most people have no idea what the NDC# is. It is a unique number that identifies the particular pill you are taking. You should be able to find it on the pill, though the number on really small pills will be hard to make out.

The bottom line is that the FDA makes it challenging to report a generic drug problem because it requires information that you will have to extract from your pharmacist and your pharmacist is not required to keep track of things like the expiration date or the lot number of your particular dispensed medicine. Nevertheless, it is important to do your best to report a generic drug problem. Again, here is the link to get you started. Good luck and please let the FDA know if you have ever experienced a generic drug problem!

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  1. Tony

    I was on Lialda for 16 years without a flare-up of my ulcerative colitis when my insurance company (without asking) switched my prescription to generic Mesalimine. Within weeks I had a flare-up. A literature search showed that the difference is in a coating that causes the active ingredient to be released at the appropriate place in the colon. The coating is different in the generic, causing the medicine to be released in a different place. The insurance company says the active ingredient is the same in both (true), therefore they are bioequivalent (false). My gastroenterologist insisted they go back to Lialda and the flare cleared immediately. I’ve been fine since.

  2. Joelle

    I see a pain specialist every month and get a prescription for norcos. A couple months ago I got a different generic brand than I usually do, and it was Amneal brand. When I took my monthly urine test, that month I had taken the Amneal brand ones, I tested positive for tramadol & I haven’t taken tramadol for over 8 years. I got the amneal brand ones again this month and am afraid of testing positive for tramadol again. How can I get one of these pills tested to see if this generic company is trying to pass off tramadol for norcos?

  3. Mary
    Knoxville, tn

    I have had the same issues with certain medications. I have been on Citalopram (orange ones) for anti-depression. My last 90 day refill is with is with Mylan. I didn’t put it together until approximately 3 weeks taking the Mylan version. I am having vivid horrible dreams. Nothing has changed in any of my medications except this one. I went back to my pharmacist and explained to her what was going on. Her reply was that they get whatever they get from the warehouse!

    This is obviously wrong for them to just change the brand of medications because their company is trying to save a dollar while still charging me the same amount for an inferior product! I can not even get my regular version because they don’t have it an I am on a limited budget. I can only afford x amount for medications. Pharmacist and manufacturers should be held accountable for putting patients health in jeopardy.

  4. k

    my thyroid went from a 1.5 to 64….. I was taking the medicine from walmart. How do we get the sh*t tested? I have been on it for 15 years…..there is NO way it takes a drop like that if you are taking your meds…..

  5. Estella
    Diamond Bar CA

    I take fenofibrate a generic for TriCor. Recently I was switched by RiteAid to a 90 day supply. Mylan lot 3056513 145 mg tablets. When I ran out I called for a refill and was told that I was twenty six days too early. So I had to wait without my medecine for almost a month. Got the new bottle, which was sealed claiming it had 90 tablets but it has 63 pills. What do I do? This is stealing! I can’t believe the manufacturer is skimming almost one third.

  6. Julie Albanito

    Metforman there is something very wrong!! I have been taking 500MG for about 4 years and it has been working just fine. Now, it is no longer working very well. I though it was just me however, tonight after going to dinner with a friend I find out her Metforman is no longer working for her. Sooo I called my other friend who is also on Metforman and she is also having the same issue with her sugar levels. All three of us on the same medication for the same diabetic II reason and all three of us having the same issue with the same medication. I could see if it was only one or even 2 but all 3 off us on the same medication and all three having the same problem that is a big issue!! The manufacture is AMNEAL and yes all three on the same med

  7. Crystal

    I am writing this important post in regards to the to the pharmaceutical company MYLAN. I have been on Xanax/Alprazolam for approximately 12 years. Just recently I started to notice a difference in the potency of my pills. Rite Aid starting using a different pill that was new to me & I didn’t think twice about it. I thought it was me & I must be building a tolerance.

    This went on for about 7 months & my aunt calls me to tell me that she just picked up her prescription & she was given the same pills that I had been taking. She said immediately NO its not YOU these pills DON’T WORK! I felt a sigh of relief, I told my Psychiatrist the next time I saw her & she said she hadn’t heard any complaints about MYLAN but she would write on my prescription NO MYLAN.

    So I filled the xanax/alprazolam at a different pharmacy & to my relief the pills Worked!

    Psychologically I wasn’t alright though, I felt ripped off & upset with the fact that there is NOTHING that I can do to fix the problem. But now I’m embarrassed that every time I get my prescription filled I have to ask what manufacturer they have & the pharmacists don’t make it easy on me, they look at me like a pill popping addict. I hope that at least one person can be reassured by this post that its NOT YOU! I THINK IT’S MYLAN!

  8. David

    A week ago I was force to o to a generic type Nexium from my company pharmacy, Express Scripts, instead of the brand name Nexium that I have been taken since 2001. Each day since making the change I have fought with tremendous intestinal cramps and Loose bowels. I cannot go anywhere. These Dr. Reddy generic drugs are crap, literally.

  9. juicy404

    I am disgusted with these generics and think they need to be stopped. I received mylan pills these month and the only thing they do is make me feel worse! I will not longer be a guinea pig.

  10. Bart

    If people did not consume so much sugar, (in hidden forms also) the economy would enter a recession because no one would have to see a Doctor so often. Consumption is about 160 pounds of sugar a year for the average American. Hang out with any individual that never gets sick or have health problems. You will see they do not consume much sugar.

  11. Luis Ruiz
    New jersey

    I started having problems with foot pain after a month on generic metphormin from Aurobindo pharm.

  12. Nancy

    BC/BS will no longer cover my Wellbutrin XL 300 mg. They will only cover generics. I tried the generic several years ago and within weeks was experiencing withdrawal like symptoms and thought disturbances. I was promptly returned to Wellbutrin. My Wellbutrin went from $75.00 per month to over $1.400.00. BC/BS said that even a letter from my MD would not help. Does anyone know of a generic that is bio-equalently the same as or very close to Wellbutrin XL 300mg? My pharmacy can get Greenstone or Parr generic. Please advise.

  13. risa

    My Metformin Hcl Tabs 500mg are NOT working. I take 1 Tablet After Breakfast and 2 Tablets After Supper. Never have my Blood Sugar Readings been this HIGH. The Mfg. Aurobindo is Not Working. I have been on this Mfg. brand for a month Very high levels. Something is very wrong with this medication. These pills are not working. What should I do?

    • Kathy

      Different dosage, but same experience you describe. Plus other side effects.

      2nd med from Aurobindo also prior unknown side effects plus did NOT treat the cause it was prescribed for.

      Both generic meds taken years before with desired results, no side effects until pharma was switched to Aurobindo.

  14. C'Aira
    Endicott, NY

    Why isn’t there a warning on “the Pill” (oral contraceptives) about possibly causing thyroid issues? I’ve read that this is a very common issue. I’m also having this problem (hypothyroidism). I am very upset that I only hear about this issue happening so often when I have this problem and I have to dig around for information. And the fact that it could stick around for life all because of a pill messing with my hormones! There needs to be a warning and OB’s need to tell their patients! I’m tired of being sick and tired and Levothyroxine is not making me feel much better. Wish I could have avoided it all! Especially because thyroid issues do not run in my family!

    • Terry Graedon

      Usually the research seems to indicate that oral contraceptives (and postmenopausal HRT) alter the thyroid blood test results without making significant changes in thyroid function.

    • Suzanne

      Try having your doctor put you on Armour thyroid. I was on levothyroxine for about 30 years and started having really bad side effects. I itched all over and felt like bugs were biting me. I had constant heartburn, my hair was falling out, so my doctor suggested Armour thyroid which is all natural. It has made a huge difference. And by the way, I had stopped taking the levothyroxine for a couple month and first felt great and then started feeling really lousy, so had blood work done and my number was 114.4. On the Armour for 6 weeks and my level is in the middle of the normal range. Armour is not covered by my insurance and costs me about $84. for 3 months, but just found out I can get it from Canada for $55. I hope this information helps you!

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