Lilly Updates Label: A Little Too Late

The good news is that Lilly has updated its warnings for Zyprexa (olanzapine) and Symbyax (olanzapine/fluoxetine combo). Here's a bit from the PR release:

Specifically, the changes include new warnings for weight gain and hyperlipidemia (elevation of triglycerides and cholesterol) and updated information in the warning for hyperglycemia (elevated blood sugar), including additional language on a greater association of increases in glucose levels with olanzapine than with some other atypical antipsychotics.

Here's the tragicomic part:

"Today's communication is part of Lilly's historical and ongoing commitment to inform doctors and patients about updated prescribing information," said Sara Corya, M.D., global medical director, Lilly.

AND

"Lilly continues to recommend that clinicians consult expert guidelines for treating people with antipsychotics, particularly the monitoring of lipids and blood glucose, regardless of the medication prescribed," Dr. Corya said. "Over the last several years, the company has been actively informing healthcare professionals about these recommendations."

Yes, Lilly is all about honestly sharing information. Please read my prior post on the incredible shifting Zyprexa glucose data here. Read a whale of a great post from Furious Seasons on how Lilly tried to play weight gain on Zyprexa off as a benefit of treatment (!) here. Interesting questions about Lilly's handling of the glucose discussion can also be seen here. If you have some time to burn, look through the above posts, then tell me Lilly has a "historical and ongoing commitment" to sharing data openly and honestly.

As for the expert guidelines, yeah -- great idea! Like TMAP -- read my postabout how the research supporting said guidelines for treating bipolar disorder is flimsy at best, yet these "expert guidelines" are oft-cited as a great example of the good that comes from expert guidelines. Oh, and did I mention that the "expert guidelines" are often authored with the help of industry?

Here's the bad news. Really bad news. Philip Dawdy has posted an interview with the mother of a man who took Zyprexa, apparently piled on the pounds, and then allegedly died of "profound hyperglycemia." It is a sad, sad story and well worth your time to read it.

While you're there, look around the Furious Seasons blog and ask yourself, "Is there anywhere else where I can find this type of mental health coverage?" I bet you'll say no. If you want continuing coverage of these issues, I suggest that you contribute whatever you can to Philip Dawdy, author of Furious Seasons.

Glucose and Zyprexa

Increased glucose levels are generally considered a risk factor for diabetes. Thus, there has been some concern that olanzapine (Zyprexa) may increase glucose levels, which may relate to the increase in diabetes incidence among users of Zyprexa. Glucose is not the only risk factor for diabetes, but it is generally a concern if a medication tends to increase glucose levels.

The following is some rewording and summarizing of Furious Seasons' recent post on one document related to the Zyprexa-glucose issue:

Lilly had some data indicating that patients who took olanzapine plus mood stabilizers had a mean increase in glucose levels while patients who took placebo plus mood stabilizers showed, on average, a mean decrease in glucose levels.

Dr. Mauricio Tohen of Harvard/Lilly (interesting combination) said that he would like to include the above information when discussing Zyprexa data because he said that the glucose increase was reversible. However, another Lilly official pointed out that since Lilly is aiming for long-term treatment with Zyprexa, pointing out that glucose increases can be reversed when the drug is discontinued does not make much sense. Good point: If the drug has a side effect that can be reversed if you stop taking it, don't tell anyone -- they might not take your drug in the first place!

I'd be interested in tracking down what exactly happened to this data, including whether it ended up hitting the scientific literature in a manner that was accurate, or whether the glucose issue was swept under the carpet. More to come on this one if I can successfully dig up more information.

Mega hat tip to Furious Seasons, who continues his excellent reporting on all things psychiatric, with a special focus on bipolar disorder, schizophrenia, and pharma. I strongly encourage all to read his post on glucose and Zyprexa here.