WARNING: All Pills Are Not Created Equal

 

Our son was taking his medicine when, all of the sudden, he started showing signs that he was slipping and becoming ill again. My first thought was: ‘He’s stopped taking his medication.’ That’s what his psychiatrist thought too. But it was something else entirely.”

This email from a concerned mother is one of several that I’ve received about a problem that may impact individuals who have been diagnosed with a mental disorder and take anti-psychotic medication.

The mother’s adult son, Phillip, had been doing well on an anti-psychotic drug for several years. Diagnosed with bipolar disorder in his early twenties, Phillip had suffered several mental breakdowns until his psychiatrist found the right medication and dosage to help him achieve clarity without causing severe side-effects.

People react differently to medications. Some do well on one brand, others may react horribly. I do not endorse any specific medications. But this story happens to be about Zyprexa, which was developed by Eli Lilly and is based on olanzapine. When Phillip began taking Zyprexa, his mother said he suddenly became “his old self.”  His mood swings stabilized. His thinking cleared and he was able to get a full-time job and move out of his parents’ house. In her words, it was a miracle.

In her email, Phillip’s mother told me that her son was diligent about taking his medication because he knew what could happen when he wasn’t medicated.

     “He didn’t want to lose everything that he had worked so hard to achieve.”

So when Phillip began showing signs of mania and depression,  his doctor and parents became concerned. ”

     “We couldn’t figure out what was happening because we knew he was taking his pills. It was as if they had stopped working and that terrified us.”

His doctor suspected that Phillip’s body had developed a tolerance or immunity to Zyprexa. Perhaps the drug’s usefulness had run its course, he said. But when Phillip became so sick that he had to be hospitalized, he responded well to Zyprexa.

What was going on?

It was at this point that the family realized that Phillip’s pharmacist had switched him from Zyprexa to a generic form of olanzapine. This is because Lilly’s patent for Zyprexa ended in October 2011, making it possible for other companies to issue much cheaper copies.

      “We thought generics were the exact same drugs, but they aren’t.”

In Phillip’s case, the generic was not as effective. Once his doctor increased the dosage, Phillip was able to return to his normal lifestyle.

Of course, no one is as unhappy as Eli Lilly is about the use of generics. In 2010, Zyprexa’s worldwide revenues were more than $5 billion, accounting for nearly 22% of Lilly’s full year sales. Since 2003, Zyprexa consistently had revenues of more than $4 billion. Which is why generic drug manufacturers were quick to begin copying it when Lilly’s patent ended last year.

Generic manufacturers must have approval from the Food and Drug Administration that shows the active ingredient in their product is approximately the same as that of a brand name.  However, two drugs that are considered to be “pharmaceutical equivalents” when they contain the same chemically active ingredient(s) still may work differently.

Here are a few reasons why:

1. the inert ingredients added to the generic drug might be different from the original.

 2. the plants used to make the ingredients may vary in quality by batch and manufacturing methods. According to a New York Times article, nearly 80 % of drug ingredients used to come from plants in Western Europe. Now more and more manufacturers are using plants from China, Japan, South Korea, India and Eastern Europe where they can be produced more cheaply. These sources do not necessarily meet FDA standards yet they continue to be used.

 3. in oral drugs, capsule content may be 7% over or 7% under the non-generic pill. This means in a 100 mg capsule, the active ingredient  –olanzapine — my be as low as 93 mg or as high as 107 mg. Some persons with mental disorders react to slight changes in their drugs’ potency.

4. generic manufacturers have been known to make changes to the formula  that they are using after their drugs are approved by the FDA.

My good friend, Judith Robinson, a mental health advocate and NAMI leader in Miami, was one of the first to tell me about how critical dosages can be. Her son, Jeff, needed exactly 12.5 milligrams of Zyprexa. If he took more, he became droopy. If he took less, he became anxious. The dosage had to be percise.

I want to thank Phillip’s mother for alerting me to the problem that some generics can cause for patients who take Zyprexa now that it is off its patent.  I have asked several psychiatrists if they have seen similar cases. Several told me that they had. One told me:

     “Most generics work fine, but if a patient begins showing signs of distress, checking the generic should be the first step everyone takes.”

 

 

 

 

 

About the author:

Pete Earley is the bestselling author of such books as The Hot House and Crazy. When he is not spending time with his family, he tours the globe advocating for mental health reform.

Learn more about Pete.

  • Gerri

    My thirteen year old grandson has shown the same symptoms, tantrums and old behaviors have returned. We thought it was growth, and hormones. I have a phone call in to his psychiatrist. Thank you.
    Gerri

  • MaryT

    but remember that bipolar disorder is by nature cyclical, and that episodes can happen even when a person is consistent in taking meds. and with no switch to generics.   For some, a night or two of poor sleep can trigger an episode.  It drives me crazy when people ask, “did s/he go off  his/her meds?”  NO!  S/he has bipolar disorder and this just happens. Beware of pharmacies switching among different generic brands too– the generic you got last month isn’t always the one you will get this month– they often go with whatever is the cheapest.

    • http://www.facebook.com/theresaclemonshamilton Theresa Clemons Hamilton

      True..They changed my migraine meds to a cheaper one & it didn’t work. I suffered the whole month. They refused to carry the brand that worked so I switched to another pharmacy. They promised to keep the brand that worked, then within a couple of months he done the same..wouldn’t even look uo at me. Now im driving 45 mins away cuz thry wanna pocket a few extra dollars :(

  • southeast mom

    Thanks for the attention to this issue. This problem is particularly acute when it comes to anti-convulsants. As a result, we pay a higher copay for brand Lamictal; thankfully, the insurance hasn’t (knock on wood) forced us to generic. As our son is non-verbal, we can’t really monitor small changes in the drug efficacy until increased seizures occur; our psychiatrist told us the generics can actually be 20% more or less potent and still meet standards. This is not a good thing when dealing with epilepsy. We take a chance with the risperdal because the stakes are not as high, but we do use a pharmacy that doesn’t switch the generic at will because that can also be a problem.

  • JAS

    My brother (55 yrs.old-Schizophrenic) had been on Zyprexa zytis (dissolves in mouth without water) for the last 7 years and did very well on it.  He has recently declined and is getting negative symptoms so doctor upped his dose. Not sure why he is becoming symptomatic again as we believe he’s taking this med and there has been no emotional traumas or stressful situations for him. The medication box says Zyprexa zytis.  Isn’t this the brand version and not the generic version of the drug?  Isn’t Olanzipine the generic version? We are confused about generics versus brand. 

  • JAS

    UPDATE as of 6-1-12, from  “JAS” — My brother decompensated enough to be sent to the hospital.  Doctors there said they have seen one other patient that switched from Zyprexa to the generic Olanzapine who landed in the hospital, althought I suspect that there are more cases that exist because they just fall through the cracks that doctors and/or family members do not simply recognize this generic issue. We have only now discovered that my brother was somehow switched from Zyprexa Zydis to Olanzapine (generic) without our knowing.  Looking through his pharmacy records, we’ve see that when he was switched, he stopped taking the pills (generic Olanzapine.)  Coincidence?  I believe not.  We believe the insurance company did this switch automatically since Zyprexa’s generic (Olanzapine) was only recently released (I believe in Sept. 2011 or Dec. 2011).  My brother got switch in Feb. 2012; went off his meds March 2012.  I’m guessing that we might be seeing an uptick in some patients who do not respond well to the generic.  (I will add that when I’ve been switched from a brand to a generic drug – (one was for painkiller for my shoulder and one an antibiotic) — I’ve had problems myself.  With one generic I landed in the ER and overnight hospital stay since the generic painkiller affected my heart and made it speed up.  I adivse those interested in this generic versus brand issue to research on Pharmacist’s Joe Graden (sp?) ”The People’s Pharmacy” website and pass him your negative experiences with  ANY generics. Again, it seems that not all people have problems with generics; many people do OK with generics.  My brother and I seem to be the few who do have problems with generics.

  • Dennis Herman

    Bingo ! Thanks folks ! Mom was on Zyprexa and the pharmacy made the change to a generic olanzapine. I think it may explain why her behaviour has become more hostile and aggressive again.

  • jas

    JAS UPDATE (Feb. 7, 2013)  Zyprexa Zydis (dissolves in mouth without any water.)  Regarding my brother who has paranoid schizophrenia, here’s a new twist and update.

    Yet once again, the insurance company has thrown a monkey wrench into the spoke’s of my brother’s life. They’ve withdrawn payment for Zyprexa Zydis and will only pay for it’s generic Olanzapine. If my brother was to pay the entire cost of Zyprexa Zydis at his dosage, out of pocket, it would cost him over $2000 A MONTH.  So once again, we’ve “pushed back” at the insurance company and demanded an “exemption” so that they WILL pay for his Zyprexa Zydis. We spoke to his psychiatrist and she agreed that  it would be in my brother’s best interest  to stay on Zyprexa Zydis and not switch to Olanzapine (generic version) because he experienced problems with it in the past.  Unfortunately, it took almost two weeks with paperwork & approvals for him to get back on Zyprexa Zydis. It’s true that many people do fine on generic drugs.  However, the fact that this change in meds was prompted — (not by a medical decision, but by an insurance decision in the name of cost-saving profit that was not in the best interests of my brother) – really bothers me.  So I’d like to remind everyone to “push back” when these insurance companies are not making decisions in the best interests of the your loved ones, whether that’s for treatment, therapy, medications, hospitalizations, etc.

  • http://www.facebook.com/theresaclemonshamilton Theresa Clemons Hamilton

    Thanks for the info. My dad suffered with manic episodes. It was hard to get him help becuz he would drink & self medicate as u know most do..nami here in my area was helpful in helping learn..dad passed Nov 3, 2012. I see two out of five of his daughters & a son that’s 24 & shows the same symtoms. Now he’s moved over 8 hrs away & it’s been over 3wks since ive heard from him. Pls pls pray…i feel so helpless & worried sick.