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FDA Approves Generic Versions of Zyprexa, a Mental Health Drug

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Zyprexa, a popular drug used to treat the mental disorders schizophrenia and bipolar disorder, is now available in generic versions. The U.S. Food and Drug Administration approved the generic versions on Monday, according to a news release.

The drug is available in regular tablets and orally disintegrating tablets, according to the news release.

Zyprexa, or Olanzapine, can cause different side effects like drowsiness, restlessness, depression, strange behavior, weakness, weight gain, sexual issues, dizziness, abnormal periods, breast growth and constipation, according to an article from the U.S. National Library of Medicine.

David Reiss, a psychiatrist and soon-to-be interim medical director of Providence Behavioral Health Hospital, said in an email that the availability of generic versions for Zyprexa is important for some patients.

“For patients who do well on Zyprexa without significant side effects (and I have seen some people for whom that definitely is the most effective agent), the availability of a cheaper version, and perhaps increased coverage by insurance companies, can be very significant,” Reiss said. “Any time there is a cheaper but equivalent version of a medication available, it allows for more flexibility in prescribing due to the practical issue of cost.”

He said he has experience prescribing Zyprexa over the years, and that it can be very effective compared to other similar medications, but it depends on the individual patient.

“In my practice, and ... most psychiatrists I know would agree, Zyprexa/olanzapine is often very effective, and for some patients, the most effective anti-psychotic,” Reiss said. “ However, there is the very significant ‘down-side’ that Zyprexa has probably the most risk among the anti-psychotics of causing metabolic changes, diabetes and weight gain.”

Due to the likely side effects, he said he only suggests Zyprexa for patients if other medications are ineffective. Also, he added that generic drugs in general can be less effective than brand name medications.

“Theoretically, there should be no difference between generic and brand-name medications,” Reiss said. “However, FDA regulations only require that the potency of generics be within approximately 20 percent of brand-name meds.”

When making a switch from brand-name to generic drugs, it’s important for doctors and patients to monitor any changes, he said.

“Additionally, generics can be manufactured differently, with different non-active ‘binders’ to make the pill (if it is not a capsule), and in some individuals, this can affect the rate of absorption,” Reiss said.

Dr. Rick Hill, a psychiatrist and the chief medical officer at Recovery Resources, said in an email that the brand name drug Zyprexa is very expensive, so a generic version could save many patients a lot of money eventually and make it more accessible to other patients.

“I believe it is an important approval because this medication is so widely used for the severely mentally ill, and lowering the cost should allow more patients to benefit from it,” Hill said. “Also, Zyprexa (brand name) is extremely expensive and costs the taxpayers ... an enormous amount of money to pay for an individual with, say Medicaid, to take this medication.”

To get an idea of the cost, Hill said “a 30-day supply of 10 mg Zyprexa is somewhere around $600.”

Hill also works at Community Mental Health Center, and he said one patient takes 60 mg of Zyprexa at a cost of $3,600 a month, not including other medications she is taking. If she took anything less, she would be considered “acutely psychotic.”

He said it’s uncertain how quickly the price will drop for the generic version, but some factors make the price-drop promising.

“The fact that there is more than one manufacturer for Zyprexa moving forward is also ... great as I would imagine this will drive down costs faster than if it were being produced by a single entity,” Hill said.

He said that at the center he works at, there tend to be more severely mentally ill patients who need medication like Zyprexa.

“Those patients often need prompt effective treatments, and Zyprexa is definitely one of those,” Hill said. “Many of the patients have treatment-resistant forms of illness, and powerful effect of medications like Zyprexa are needed. [We] tend to use a fair amount of Zyprexa at our agency, and in general, our patients do quite well on it.”

However, he agreed with Reiss that weight gain and metabolic changes are harmful side effects that could occur and must be considered.

Sources:

FDA. FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder. Press Announcements – FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder. Web. Oct. 26, 2011. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm277022.htm

PubMed Health. U.S. National Library of Medicine. Olanzapine. Olanzapine – PubMed Health. Web. Oct. 26, 2011. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000161

Reiss, David. Email interview. Oct. 25, 2011.
Hill, Rick. Email interview. Oct. 26, 2011.

Reviewed October 27, 2011
by Michele Blacksberg RN
Edited by Jody Smith

Add a Comment3 Comments

EmpowHER Guest
Anonymous

Zyprexa is part of a class of medications called atypical antipsychotics that effect levels of dopamine, a brain chemical that controls behavior, mood and movement. Drugs like Zyprexa can cost up to $500 per month. Generic versions can cost up to 80 percent less.

February 27, 2013 - 4:07am

FDA should make their policies easier and simpler so that new generic drugs can be used by people. It's good that they approved generic drug for Zyprexa for mental conditions. FDA should regularly try to invoke new generic drugs so that people can make use of cheap drugs to treat their problems. FDA is been increasing generic drugs for impotence but drugs for mental problems, stress, heart condition must too be increased for the welfare of people.

December 20, 2012 - 10:53pm
EmpowHER Guest
Anonymous

From what I have seen for patients that stay hungry after a couple of months and the psychiatrist is to dumb to change their meds are the ones that get the diabetes because of their huge wait gain. Usually the hunger gradually goes away.

February 23, 2012 - 12:29pm
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