The People's Perspective on Medicine

Generic Drugs Banned in Europe But Not in the US

Why have European regulators banned so many generic drugs? What do they know that we do not? The FDA says don't worry, be happy. Really?

Over a year ago we received a message from a pharmaceutical research scientist. He worked for a large clinical research company in India that tested generic drugs to see whether they reached blood levels identical to the name-brand originals.

Our correspondent was a whistle blower. He alleged that this company had committed “misconduct, regulatory violations and intentional fraud analysis in the process of generic drug testing on healthy human volunteers.”

He criticized the U.S. Food and Drug Administration for failing to fully investigate his allegations and uncover the fraud. We had no way to verify his charges.

But now European regulatory authorities are banning a number of generic drugs that were based on data generated by an Indian testing company, GVK Biosciences. Last year French inspectors turned up irregularities in electrocardiogram data from GVK. The questions that were raised triggered further investigations.

As a consequence, on August 21, 2015, the European Union suspended the sale of about 700 different generic drug formulations. The European Medicines Agency (EMA) originally approved these generic drugs based on clinical trial data from GVK Biosciences. Not all drugs tested by the firm are being banned, and GVK has expressed its disappointment in the decision.

Some of the drugs that are affected by the European ban include the antihistamine fexofenadine (Allegra), the seizure medicine levetiracetam (Keppra), the blood pressure pill nebivolol (Bystolic) and the antidepressant venlafaxine (Effexor). There are hundreds more.

What about the FDA? A spokesperson told the Wall Street Journal blog Pharmalot,

“We have identified the U.S. applications that include data from studies conducted at GVK Hyderabad, and FDA’s subsequent inspection in September 2014, did not reveal systemic issues that affect the safety or efficacy of drug products subject to pending applications or products approved in the U.S.”

That means that Americans may be exposed to generic drugs that European regulators have rejected.

We find it fascinating that the U.S. FDA inspection found “no evidence of systemic issues” while the European inspectors were so concerned with what they found that their regulatory body banned roughly 700 generic drugs as a result of their investigations.

What Happens When a Generic Drug Fails?

One of the generic drugs that was banned in Europe was levetiracetam. We have heard from dozens of readers who have had trouble with this epilepsy medicine. Here is one story:

“Last year I was put on generic Keppra. I started having breakthrough seizures after three years of seizure control on brand name Keppra.

“I told my doctor the generic Keppra was the trouble. She wanted to put me on another anti-epilepsy medication. I flat out refused and asked to first try the brand name Keppra again. I am now back to a normal life.”

Many people don’t realize that their generic drugs may be approved based on clinical tests conducted in India, China and other countries where oversight could be less rigorous than in the U.S. If the data that is submitted to the FDA for analysis is flawed, then we may not be able to trust that the generic drugs are truly bioequivalent to their brand-name counterparts.

Over the last several years there have been numerous scandals involving lax manufacturing practices at generic pharmaceutical firms in India. Now we have learned that some of the companies that do human testing to get generic drugs approved in the first place may also be cooking the books.

We should not have to rely on whistle blowers to reveal fraud. Their lives are often turned upside down. Not only do they lose their jobs, they may never be able to work within the pharmaceutical industry again. In foreign countries they may even be prosecuted for revealing fraud.

The banning of 700 generic drugs in Europe should serve as a wake up call for Americans. Physicians, pharmacists and patients in the U.S. deserve the same protection that European regulators provide their citizens.

The EU listings can be found here:

http://ec.europa.eu/transparency/regdoc/rep/3/2015/EN/3-2015-5100-EN-F1-1.PDF

http://ec.europa.eu/transparency/regdoc/rep/3/2015/EN/3-2015-5100-EN-F1-1-ANNEX-1.PDF

 

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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I have been taking the generic Celexa for many years without problems. Then Walgreens switched manufacturors to Aurobindo from India. I started experinencing constant nausea and other gastric issues immediately after starting the new pills. I called Walgreens and told them the new pills were making me sick and they agreed to special order from the old company Watson.

The problems went away. Then I read on this site tha Aurobindo was one of the companies spanked by the FDA. Not surprising at all. I don’t know what is wrong with the FDA, whether they are just overworked and under staffed like all government agencies, but I think they need a serious house cleaning starting from the top on down and that includes congress who allows this agency to function this way.

Only the wealthy people get the BRAND name medications. That’s why they are so healthy.

I was on name brand Wellbutrin XL years ago and it was the only antidepressant that worked for me. Now I can only get the generic and there are loads of unpleasant side effects that I didn’t experience on the name brand.

I was put on Lamictal and Welbutrin for bi-polar disorder. It changed my life and I have been stable, functional and happy for years. Since on Medicare, my supplemental policy (BCBS-Prime Mail Pharmacy or Humana Pharmacy) only pays for generic drugs. Almost every time I get a refill, the medications are from a different pharmacy. I can definitely tell the difference and go through rough periods every time. I am very worried.

Great articles, thank you. I have experienced problems with generics that have been ineffective where I’ve had success with the brand names for many years.
I have experienced problems with Zolpidem generic substituted for Ambien CR. Ambien allows me to sleep through the night. I can not sleep more than 3 to 4 hours, and interrupted sleep at that, with Zolpidem the generic, it’s ineffective.

I suspect that celecoxib generic is mostly fillers and indigestible matter, as it is ineffective and inconsistent, whereas Celebrex brand works wonders for my constant low back pain, and raises the quality of my life. I manage chronic herniated disk pain with a combination of ice, Biofreeze, stretching, etc., and a high quality NSAID Celebrex is the only effective drug for my pain. I have also tried Naproxen generic for pain, recently due to an insurance change, where they make you wait and after weeks you think you will lose your mind as they force you to keep trying drugs you know don’t work, and suffer through the hideous side effects and pain of your condition for the time they- not you and your doctor decide. For the Naproxen trial, I have to take 4 pills through the day, with the resulting ups and downs of pain that make this untenable. It upsets my stomach, gives me headaches. This is an unethical and questionable practice… insurance companies are holding us hostage.

Who doesn’t want a less expensive copay? Thats their selling point, not, Who doesnt want a more effective drug to manage a health issue? The highest copays are not disclosed to consumers until after a consumer is a captive enrolled in a plan. This must cease.

I looked at the list of banned drugs linked to above.

Almost all are manufactured in European or that general area rather than the Indian generic drugs we have received complaints about here earlier.

The problems seem pretty much worldwide as far as generics are concerned.

Almost all are manufactured in European/quote.
I have been having problems with several Indian generic drugs.
It seems that some that have a Euro address are just rebadged
Indian drugs probably packed to order in India.The packaging may be different but the pill size and identifying mark on the pill are the same.Also the film coating on the pills is poor and they
are difficult to swallow and get stuck in the throat.But the good old NHS are saving money thats all that matters.

I’m afraid you didn’t read carefully: the Marketing Authorisation
Holders are European, of course (that’s why the European control agency is involved), but the drugs are tested (which is what what was under investigation) and manufactured in India, as you can argue by reading the scientific conclusions.

I have been taking Diovan for years for high blood pressure. When I started taking it there were no generic drugs. When I started taking the generic I had no reaction. Last month my pharmacy changed manufacturers and I had an immediate reaction. I was anxious, light headed and generally just feeling strange. The new manufacturer was from India, replacing Sandoz. My MD requested that the prescription be filled as written with the manufacturer continuing to be Sandoz since I could tolerate that generic. My pharmacy just informed me that they would no longer be using the Sandoz generic. My question: As consumers how do we fight this trend for cheaper, but not necessarily equivalent drugs. I know the drugs coming in from India are cheaper but I can’t take this new generic. I will look for a new pharmacy but think this will continue to happen. Thank you for your articles on this problem, otherwise I would not have known to check the manufacturer.

The People’s Pharmacy would do a great service if it would produce an up-to-date consensus study on the best advice for patients vis-a-vis drugs from India and China. The crux: Should we avoid them if at all possible?

Here ya go . . . THE LIST (and do not even get me started on generics — countless lives are being ruined):

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/05/WC500187078.pdf

Folks,

Here are the links to the EU ruling. Note the ruling is in the first link and the Annex with the list of suspended drugs are in the second. Note that the banned list starts on page 57 of Annex I (Annex IB).

http://ec.europa.eu/transparency/regdoc/rep/3/2015/EN/3-2015-5100-EN-F1-1.PDF

http://ec.europa.eu/transparency/regdoc/rep/3/2015/EN/3-2015-5100-EN-F1-1-ANNEX-1.PDF

I have complained to Walmart about generic Metformin that I am receiving as not being effective. They seemed very unconcerned and said that they can only sell what corporate approves… I assume the cheapest generic they can find. I will ask my doctor if I can try the name brand at my next visit.

I have suspected this for some time. Estrace generics do not work for me. My pharmacist told me to have my doctor prescribe a triple dose in order to get the hormone level I need. My drug benefit pharmacy (Caremark) makes me pay full price for the name brand (over $500/mo) because a generic is available. I have a demonstrated need for name brand. Generics leave me a sweaty blob. The same for Wellbutrin SR for both myself and my sister – back to the symptoms that the drug was supposed to help. Aciphex was the only PPI that worked for me without nausea or dizziness – until the generic was substituted (made in India). Same story as the Estrace & Wellbutrin – Caremark won’t give me reduced copays for name brand). I became dizzy to the point that I needed to hold on to walls, chairs and could not drive. I had saved a few of the name brand just in case. I tried them and no problem. Back to the generic – a problem. I wrote a complaint on the FDA website my reaction was so extreme. No comment from them. Not all generics are alike. I happen to be exquisitely sensitive to drugs. I had an allergic reaction to a tiny amount of diuretic. I am allergic to Sulfa, but both my doctor & pharmacist said that that small amount seldom causes problems. With this kind of history, one would think Caremark would be less rigid. It sure scared my doctor!

I have recently been given the generic drug imprimane, as I’ve been told by my pharmacy the brand name Tofranil which I had been taking for years for anxiety\depression, which I found the best out of long list I had tried! is no longer being manufactured so have no choice to accept the generic for the last 3 weeks, even though I feel its not working the same as the other brand, despite being told all the time by my pharmacy they are the same, but things have changed with me ever since I started using the generic, my mood is bad, & no change other than that all d time, my sleep is also different, does this happen with anyone else, just feel I’m at the end of my tether at this stage!!

Is there any way to get a list of the banned generic drugs in the Euro Zone?

I wish to obtain a copy or list of generic drugs that Europe has found unsatisfactory… Joe Graedon, has suggested we write him through PeoplesPharmacy. Thank You, elaine

How do we find out which generic drugs have been banned in Europe?

And are insurance companies and VA required to provide name brand drugs if a doctor prescribes it even if a generic is available?

We don’t know any details of the facts which led the French regulatory authority to push for a ban on these 700 odd “GENERIC” formulations which were approved by various European regulatory agencies on the basis of “Bioequivalence” study reports submitted by the Contract Research Organization under scrutiny. We understand that these 700 odd studies were conducted over a period 2004 to 2014. ( ten long years ! ). The laboratory in question must have been approved several times during these ten year by these regulatory agencies.

How come after accepting study reports on 700 odd formulations over ten long years, they suddenly find the reports fraudulent? That too not on the basis of analytical data on blood levels of concerned drugs estimated in (at least) 12 X 700 X 24 normal healthy human volunteers that must have been studied? The reason offered appears so flimsy! Which particular drug among these 700 odd formulations could be assessed as “Non-Bioeqivalent” on the basis of its effect on the ECG of the human volunteers ?

Re: the article on European Union suspending sale of 700 different generic drug formulations, you mention only four:
fexofenadine (Allegra), levetiracetam (Keppra), nebivolol (Bystolic), venlafaxine (Effexor). Can you name the other 696 generic drugs suspended?

Is there a site to examine which drugs were banned in Europe?

I’ve had many problems with generic drugs over the years, namely:
Lisinopril – Simple doesn’t work-unlike the name brand Prinivil which is not affordable or available.
Alfuzosin – Again, doesn’t work-name brand Uroxatral works-and is not affordable.
Fluoxetine-Doesn’t work for my spouse-name brand is obscenely overpriced.
Any drug manufactured by Greenstone-including Atorvastatin and Sulfasalazine-Greenstone should be black listed.

Provide a link to the GVK data.

I wonder why does the FDA not protect the American public? Who do they work for? I am disappointed

For many years I used Lidoderm brand lidocaine patches to control back pain. My most recent refill, however, was a generic said to contain, as did the Lidoderm, a 5 percent solution of lidocaine. The generic does not control the pain nearly as well as the Lidoderm brand, and the substrate, a cloth impregnated with the lidocaine, is thinner—so thin, in fact, that the lidocaine solution makes the cloth wet and leaks onto clothing, something the Lidoderm never did. The generic is from Watson Laboratories Inc. I understand that Watson Pharmaceuticals Inc. is Now Actavis Inc., which seems to be a division of Allergan, based in Dublin, Ireland.

Very worrisome. I would like to see the list of the 700 drugs the Europeans banned and I am skeptical that the FDA really looked all that closely.

Thanks for pointing to a location of the banned generics.

Where is link to list ???

Dear Terry and Joe….
I appreciate the terrific job you do with regard to medicines, both ‘big Pharma’ types, and holistic. Since I have taken Venlafaxine (Effexor) for a number of years, and at times wondered if there was any effect from it, I am interested in knowing if any so called ‘effect’ could vary from one refill to another? Also, how can I get a list of the meds banned in Europe?

Thank you!

because of my 46-year history of killer migraines, I have depended upon one or another of the 7 triptan drugs since they came on the market over 20 years ago. These are the ONLY drugs targeted to migraineurs’ special brain chemistry, and are NOT pain drugs. When the 2 triptans which work for me became generic a couple of years ago, I was made to try them by my insurance company. ALL generic manufacturers were tried, and NONE worked. zip, nada.

Then I fought through my primary doctor and neurologist to get the brand names. It was a huge struggle, but I could not get out of bed and function were it not for these brand-name drugs, which remain outrageously expensive, at $30-$40 per pill. When one takes them daily, out of necessity, this cost is prohibitive, of course. Thankfully, there are studies which show that for patients without heart issues, it seems perfectly safe to take them daily, when surgeries, injections of all kinds, and many other treatments have been tried through many years. It is necessary for me to work 30 hours per week at age 75, and these drugs make that possible for me. (generics stink, imho)

I had two generics of Flomax and a brand statin… Both came from India and both hit me all at once.. I had to stop taking them. This is a corrupt country and we shouldn’t be sourcing pharmaceuticals from there in my view.. No telling what the fillers are…

Thanks for the article. Is it possible to share the list of the names of the generic drugs?

Toni,
I understand your concern about drug safety, although I have been fortunate to substitute herbs and homeopathy for drugs…I just said no to chemicals as one of our past presidents had urged.
All countries harbor corruption. We have our own scandals Vioxx, tranquilizers(drugging women), Ritulin (drugging children) and Viagra(drugging men) and the new female sex drug created for a problem that does not exists, “Female sexual dysfunction”
I would not say India is any more corrupt than the US without proof. Remember it is the Europeans not our FDA that has banned these generics. What does it say about us if we were informed about the problem and the FDA did not react. We should not throw stones of corruption when our FDA is housed in Glass. I write this in the greatest respect to the audience.
An American in Germany
Rich

I have just recently converted to the generic form of the B P drug Exforge. It, along with the drug HCTZ, gave me major kidney stone problems. I finally had to quit HCTZ and that problem went away. HCTZ was an added drug, with Exforge, to keep my BP low. Now, I still seem to have my BP low enough without it, but I am monitoring my condition with the passage of time.

Thus, the generic must be different in some way!

I’m on generic Effexor and have been having chronic head pain for the past 6 months. It is worse when I bend over, sneeze, cough or strain. Now I’ve been on generic Effexor for years and have done fine, but I’ve noticed the pill has changed design (manufacturer?) with the prescription I had refilled in early 2015. I’ve had an MRI/MRA to rule out tumors and blood clots. I’ve not had any other changes in my diet or lifestyle that I can recall … so I’m wondering if possibly it’s the change in the Effexor generic. I’ve not had a chance to test my current theory. I went through a similar generic change with Wellbutrin years ago (I’m not longer taking it), and it was horrific. Was told by everyone “oh, it’s the same.” It’s not the same!!!! Something must change with these overseas drug manufacturers.

I took brand name Effexor for depression for many years and it worked very well. I’ve also taken Teva brand’s generic for Effexor (venlafaxine), and it worked just as well. But when my pharmacy gave me Aurobindo Pharma of India’s venlafaxine, my depression returned big time. Now I insist on Teva brand.

I have had the same problem with Paxil, generics aren’t the same! And have recently switched to generic clarinex and am wondering if it is nothing more than a sugar pill.

Are there not usually several manufacturers of a generic? Are these bans manufacturer specific? My husband takes generic Synthroid. We have been told that we should pay attention to the manufacturer of the generic that works best since all are not equal and pharmacies may not always dispense the same manufacturer unless specifically requested.

I complained to my doctor that I was having poor results with the generic prescription for Prevacid. She was surprised to say the least. After it went over the counter I simply went and bought it although it is more expensive. She tried writing a prescription for the drug by name but the insurance wouldn’t cover it.

I am a member of a support group for rheumatic conditions treated alternatively. It is well known that generics differ. What works for some people, doesn’t work for others. For example, the generic of minocycline made by Watson labs works for many. It does not work for me, nor does Teva brand. Ranbaxy made mino works for me. Likewise I use low dose naltrexone and those manufactured by Malinkrodt work for me while other manufacturers’ generic form does not. I don’t think it is always a matter of quality, but perhaps individual reactions to fillers and who knows what.

I take several generic drugs on a daily basis. It would be extremely helpful if you could
post a complete list of all the generic drugs banned in India as a result of testing by AVK.
Thanks

We need to put great pressure on the FDA and congress to make it possible to do better re checking drugs made abroad.

Is there a list that is available? Thanks again for such valuable information. Karen

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