Pfizer Halts Sales of Exubera In Wake of Lung Cancer Fears

Apr 17, 2008

In wake of news that its inhaled insulin product Exubera has been linked to lung cancer, Pfizer Inc. has announced that it will cease manufacturing the drug and update labels on the remaining product to carry a cancer warning.

The company revealed that in a study of 4,740 patients taking Exubera, six developed lung cancer (1 out of every 780). In comparison, one out of 4,292 patients in the study who were not taking Exubera developed lung cancer.

Pfizer introduced Exubera in 2006 as the first inhaled insulin product on the market. By 2007, however, the company announced that it would cease marketing the product because of low demand. An estimated 4,000 people with diabetes worldwide are taking the drug.

Before receiving FDA approval to market Exubera, the drug’s apparent effects on lung function had been noted in studies – a concern that delayed approval for several years.

Inhaled insulin has been a kind of Holy Grail for pharmaceutical manufacturers since it avoids the pain and inconvenience of needle injections. When Pfizer ceased marketing Exubera last year, Novo Nordisk and Eli Lilly soon dropped their inhaled insulin development programs.

Valencia, Calif.-based MannKind Corp. has said it will continue work on its Technosphere inhaled insulin product.

Oramed Begins Studies on Oral Insulin Capsule

Israeli company Oramed Pharmaceuticals, Inc., a developer of oral delivery systems, has commenced Phase 2A studies on its oral insulin capsule at the Hadassah Medical Center in Jerusalem. The trial will focus on assessing the safety and efficacy of the capsule on 10 type 2 diabetes patients. This study is a continuation of the recently successfully completed Phase 1 studies in Israel.

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Posted by Anonymous on 16 April 2008

Pfizer stopped manufacturing Exubera several months ago when they closed the plant and laid off a few hundred people. Check your press releases, Patrick!!

Posted by Anonymous on 17 April 2008

I want to know with what mechanism and what speed inhaled insulin may produce cancer, as you know rate of lung cancer is not increased in diabetics.This idea of possible cancerogen potential needs more study.

Posted by Anonymous on 17 April 2008

The implication of your headline is false. Please be historically accurate.

Posted by Anonymous on 17 April 2008

They JUST announced they were going to pull it in Europe in the past month or so. At least I think it was Exubera that I read about here iN Germany. It seems not all markets are identical to the US market, so it's possible Patrick's not so off. Regarding the article, though... sheesh! Going from 1 in 5,000 to 1 in 780? Eeek. The second they came out with that stuff I was afraid they'd try to make us take it instead of shots or something. No way! Shots are one thing, but messing with your lungs is another. I'm GLAD this stuff is going, going, GONE!

Posted by bdebruler on 24 April 2008

Exubera, even if it happened to be entirely safe, misses the point and is the real reason it was pulled from the market. Pfizer was betting that we are all miserable from taking insulin by injection, and that we would beat down the pharmacy doors to grab their insulin "bong" (as one diabetes blogger put it). Instead we have mostly stuck with the tried and true. Injections don't hurt as much as bad marketing. We don't need another short acting insulin (inhaled, oral, or whatever) as much as we need tools that provide improved glucose control, like the insulin pump, constant glucose monitoring, and (given enough time) replacement beta cells that are encapsulated and thus protected from the immune system.

Also, the more recent news on Exubera is that Nektar, who partnered with Pfizer to develop and market it, is giving up on it as well.

Posted by Anonymous on 16 May 2008

From all I've read and seen, Exubera delivery is bulky and cumbersome and therefore not well accepted by people who use insulin since other insulin delivery devices are much more convenient. I would like further information about the cancer connection...the actual research study would be great.

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