Zyprexa – Making Lemonade out of Lemons

February 1st, 2010. By LucyC

You may recall a study that hit the news last October, published in JAMA, on the use of four new generation antipsychotics—Zyprexa, Risperdal, Abilify and Seroquel—used to treat schizophrenia and bipolar I disorder in adults and adolescents. Long story short—it was not a good news story for the kids on these drugs, and most especially kids on Zyprexa.

Why not? Weight gain, increases in triglyceride levels and associated risks for diabetes and cardiovascular disease. 

The average weight gain over the 12 week study period was the highest for Zyprexa—17 pounds. You’d be hard pressed to gain that kind of weight sport-eating your way through the holidays… 

Suffice to say an editorial in JAMA called the study results “timely and sobering,” suggesting that the new generation of antipsychotics are not all they’re cracked up to be. “These results challenge the widespread use of atypical antipsychotic medications in youth,” University of Washington, Seattle child psychiatrists Christopher K. Varley and Jon McClellan wrote. 

Well, maybe not. On January 29^th, nearly three months after the study was published, the Food and Drug Administration (FDA) issued a warning to doctors regarding prescribing information for Zyprexa, but it’s not exactly strong…here’s part of the FDA Safety warning: 

“Section 1, Indications and Usage: When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents.” 

So presumably, the prescribing psychiatrist has to determine whether the treatment benefits for schizophrenia/bipolar disorder outweigh the risk for cardiovascular disease and or diabetes? In kids? That sounds like damage control to me. 

But it’s come at a cost. 

According to media reports, Eli Lilly spent $693 million on litigation-related costs for Zyprexa in 2009—most of which apparently had to do with allegations that the company failed to warn patients of the drug’s links to weight gain and, allegedly, diabetes. (And you could argue that the FDA warning also doesn’t go far enough). But that figure is down from $1.9 billion year-over-year, apparently.

So it seems that Lilly has made lemonade out of lemons, or in this case one big lemon, because the company is spending less to defend and/or settle Zyprexa cases than it had been previously, and the drug remains on the market, even though it’s use should be questioned…

Tags: Eli Lilly, Zyprexa

This was posted on Monday, February 1st, 2010 at 5:33 pm and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.