safety concerns

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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  1. Sam
    DE
    Reply

    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.

  2. Sherry
    North Carolina
    Reply

    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.

  3. K.T.
    Troy, NY
    Reply

    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.

  4. Mary
    Reply

    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.

    • Mitzi
      Italy
      Reply

      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.

    • Chris
      uk/Wales
      Reply

      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.

  5. Jane
    Boulder, CO
    Reply

    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.

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