An Updated Zyprexa Warning Label

Zyprexa, the embattled antipsychotic drug made by drug giant Eli Lilly, made the news rounds again yesterday. Lilly announced it was adding more warnings to the drug regarding an increased risk of a number of side effects, including weight gain, higher blood sugar, metabolic problems and higher cholesterol. You can read Pharmalot’s take on the announcement, as well as the New York Time’s news article:

Internal Lilly documents disclosed by The Times last December indicated that Lilly was aware of Zyprexa’s tendency to cause weight gain and blood sugar changes by the late 1990’s but played down the drug’s risks.

Lilly said at the time of those disclosures that the drug’s risks were already reflected in the label. Ms. Lemons said the company had not delayed releasing information about Zyprexa’s side effects, and had made yesterday’s label change after a new review of clinical trials showed the drug’s potential risks.

I have a thought for companies that find themselves in deep water and sharks are circling — stop spinning the story and just tell the public the truth. The public — you know, your customers — appreciate honesty over PR spin any day of the week. If you want to understand why people get angry or frustrated at companies, just look at the ridiculous words that spill out of their spokespeople defending their actions.

This is a big win for Lilly, because they were able to keep the word “diabetes” off of the label. Being overweight and having high blood sugar are two of the common risk factors for diabetes, and any drug that messes with one’s blood sugar level certainly isn’t going to help. By keeping the scariest word off of the label, they have likely successfully minimized the impact of this new warning.

Could you imagine those awkward conversations? “We’re successfully treating your bipolar disorder, but we’re afraid the treatment has now led to type 2 diabetes.” Swapping one disease or disorder for another is rarely considered good medicine.

But Lilly could do nothing about the facts surrounding the new label’s fairly eye-opening wording, according to the New York Times:

The new label will also indicate that patients who take Zyprexa may keep gaining weight for as long as two years after starting therapy. That contradicts earlier public statements by Lilly that weight gain on Zyprexa tends to plateau after a few months of use. One in six patients who take Zyprexa will gain more than 33 pounds after two years of use, the label says. [emphasis added]

That translates into 17% of the people taking Zyprexa will likely experience significant weight gain. We’re not talking a few pounds here. We’re talking 16 1/2 pounds each year! “Sorry, ma’am, while we’re treating your bipolar disorder well, we now have to work on the self-esteem issues related to your 20% gain in body weight.”

So yes, while we agree with Lilly’s spokesperson that schizophrenia and bipolar disorder are sometimes “devastating” and “disabling” and one shouldn’t turn to older antipsychotics (carefully leaving out that some of Lilly’s antipsychotic competitors aren’t associated with these side effects), we have to kindly suggest that significant weight gain and the real possibility of having to deal with type 2 diabetes for the rest of your life are not exactly walks in the park either.

Lilly’s motivation for downplaying this change?

The new warnings may add to the controversy surrounding Zyprexa, which is by far Lilly’s best-selling drug. Zyprexa had global sales of more than $2.3 billion in the first half of this year and nearly 3 million prescriptions in the United States alone. Lilly said it had made the label changes as a part of continuing discussions with the Food and Drug Administration (FDA).

Lilly has asked the F.D.A. to allow it to begin marketing Zyprexa for adolescents, despite clinical trial data showing that Zyprexa causes weight gain and metabolic problems in teenagers that can be even more severe than in adults.

So just to connect the dots here… The FDA said, “We might be more likely to approve this additional use of the drug, but you have to do something for us first by adding to your Zyprexa warning label.” The potential addition of the teen market is significant enough to justify the change, even if it scares away some adult prescriptions.

But minimizing the seriousness of the changes does not only a disservice to Eli Lilly’s customers, but really calls into question whether they really care about their overall general health and well-being. Because the way the spokesperson, Marni Lemons, is quoted in the Times article, it appears the company clearly has no idea.