(5-3-19) FROM MY FILES FRIDAY- In March 2012, I received an email from a mother about generic drugs. Most are fine, but if you notice mood changes, investigate if what you are taking really is the same medication as prescribed.
Warning: Not All Pills Are 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.”
Phillip had been doing well on an anti-psychotic drug. Diagnosed with bipolar disorder in his early twenties, he’d experienced a half-dozen episodes until his psychiatrist found a medication and dosage that helped him achieve stability without suffering severe side-effects.
I do not endorse any medications. But this post happens to be about Zyprexa, which was developed by Eli Lilly and is based on olanzapine.
Phillip’s mother said when her son began taking it, he became “his old self.” His mood swings stabilized. His thinking cleared. He was able to get a full-time job and move into his own apartment.
“A miracle,” she wrote.
Phillip was diligent. “He didn’t want to lose everything that he had worked so hard to achieve.”
So when he 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.”
Had Phillip developed an immunity to Zyprexa? Had the drug’s usefulness dissipated?
Phillip became so sick he was hospitalized.
“It made no sense. It was heartbreaking.”
It was while Phillip was in the hospital, the family realized Phillip’s pharmacist had switched him from Zyprexa to a generic form of olanzapine. Lilly’s patent for Zyprexa had ended in October 2011, making it possible for other companies to issue less expensive versions.
“We thought generics were the exact same drugs, but this one wasn’t.”
His doctor increased the genetic dosage. Phillip improved and was discharged.
No one is as unhappy about genetic versions of Zyprexa as much as Eli Lilly. In 2010, worldwide revenues from Zyprexa were more than $5 billion, accounting for nearly 22% of Lilly’s full year sales. Beginning in 2003, Zyprexa consistently had revenues of more than $4 billion. It was a goldmine. That’s why generic manufacturers were eager to duplicate it.
Genetics must be approved by the Food and Drug Administration, which checks to insure the active ingredient is approximately the same as that of a brand name. Even so, drugs that are considered “pharmaceutical equivalents” may work differently.
Here’s why.
1. The inert ingredients added to the generic drug might be different from the original.
2. 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, whose story is told in my book, CRAZY: A Father’s Search Through America’s Mental Health Madness, told me how important it is to get the right medication and the right dose. 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 precise. Easy to see why a switch to genetics needs to be carefully monitored.
I showed the email from Phillip’s mother to a psychiatrist friend. He wasn’t surprised.
“Most generics work fine, but if a patient begins showing signs of distress, checking the generic should be the first step everyone takes.”
Sage advice.
I’d love to hear your stories on my Facebook page about genetics and other medication problems. Stay well and help others!
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