Lantus and Cancer: Further Study Needed

Late last week, results from several European studies showing a possible link between Lantus (insulin glargine) and cancer were published online in the journal Diabetologia. Health agencies such as the U.S. Food and Drug Administration (FDA) and the International Diabetes Federation (IDF) have been swift in their response to the release of this information, indicating that the studies are not conclusive and that people with diabetes should not stop taking Lantus without speaking to their doctors.


The first of the studies in question, from Germany, involved 127,031 people with diabetes who used insulin; it found that cancer was more common in people using Lantus than in those prescribed a comparable dose of human insulin. Subsequent to this study, additional research into the subject was carried out using information from patient databases. A study from Sweden looked at 114,841 people being treated with insulin, and found that those using only Lantus were almost twice as likely to be diagnosed with breast cancer. Research from Scotland, which included 49,197 people with diabetes on insulin therapy, also found that people taking only Lantus were more likely to have cancer. However, this finding did not achieve statistical significance. (A result is statistically significant if it is unlikely to have occurred by chance.) A final study from the United Kingdom that involved 10,067 people with diabetes did not find a link between the use of Lantus and the development of cancer.

On June 26, the American Diabetes Association issued a statement “caution[ing] against overreaction until more information is available.” And the FDA recently cast doubt on the research findings, saying that the studies may have been too short to assess whether a cancer risk does in fact exist with the use of Lantus. The European Association for the Study of Diabetes has requested further study into the matter.

For more information, see the published papers on Diabetologia’s Web site, the IDF’s official statement on the situation, and the article “Lantus Insulin: A Possible Link with Cancer — Requires Further Investigation.”

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  • John

    If you are going to write an article about this. You Have to mention everything that these agencies stated… NOT just part of it! It is Very important! There are so many patients(Like myself) who are on Lantus & have been helped by Lantus! By not mentioning all the facts, you can easily cause a panic. These European studies were NOT randomised or controlled. Which is what is the most respected and solid way to get data. They were retrospective. Not sound. My doctor explained it to me as they basically go backwards. This is probably why all the main, most respected, agencies quickly came out with statements defending Lantus.

    ADA Statement
    -” Findings from these research papers are Conflicting & Inconclusive” The ADA cautions against over-reaction.

    -“The data within these studies and between these studies are Conflicting & Confusing!” ADA advises patients using insulin Not to stop taking it.

    -“For patients using glargine & considering switching to another form of insulin, the data in these studies make it Unclear as to whether any one type of insulin increases the risk of cancer more that other types of insulin!


    -The authors themselves, and the accompanying editorial, cautioned against over-interpretation of their Limited data and analyses, which precluded them from drawing any firm conclusions.

    -For example, there were contradictory findings among the studies, patient populations were not always comparable, and the duration of observation was short.

    -AACE does NOT recommend that the use of any insulin be changed.

    – AACE supports further research into the effectiveness and safety of ALL Diabetes Therapies and will continue to update recommendations as further data becomes available.

    Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncotrolled blood sugar levels can have both immediate and long-term serious adverse effects.The duration of patient follow-up in all 4 studies was shorter than what is generally considered necessary to evaluate for cancer risk from drug exposure.

    -Further, Inconsistencies in findings within and across individual studies raise concerns as to whether an association between the use if insulin glargine and cancer truly exists. Additionally,differences in patient characteristics across the treatment groups may have contributed to a finding of increased cancer risk.

    Sanofi website

    June 26, 2009- Sanofi-aventis has just been made aware of data associated with a retrospective follow-up of four patient registries. The results of these data clearly show that no definitive conclusions can be drawn regarding a possible causal relationship between Lantus use and the occurrence of malignancies, as the authors of the study point out.
    Clinical studies, which represent the gold standard of evidence, Do Not indicate an association between insulin glargine & cancer.

    “Given the extensive clinical evidence covering over 70,000 patients and the results of post-marketing surveillance arising from 24 million patient-years of experience, sanofi-aventis stands behind the safety of Lantus”, said Jean-Pierre Lehner , MD. Chief Medical Officer. “We consider that the results of these patient registries are not conclusive.”
    Patient safety is the primary concern of sanofi-aventis.

    Lets not jump until solid, reputable clinical studies (That have the respect of the experts& are clinically sound) show there is a problem).


  • Pam Fults

    I just recently had my annual Cancer blood test, having had cancer twice before it is essential I keep up with those nasty cells. My cancer blood level was lower than the national level and I have taken Lantus for two years, increasing the dosage as I get older. I do not believe that Lantus is connected to Cancer.

  • Olga

    What is meant by ‘lantus doesn’t cause cancer more so than other types of insulin.’ Does this mean insulin causes cancer in general? Also, are there pre existing conditions other than diabetes in those patients who actually got cancer after taking lantus? Is lantus the cause or did something else cause the cancer, or the combination of lantus and other factors such as poor health, smoking etc.? The studies don’t seem to tell you exactly what was studied, but I must say, they have done well to cause panic. As a parent of a child taking lantus, I’m questioning whether I’m putting my child in danger. I think if you’re going to publish such an article, you need to get all the facts. I think dealing with diabetes is hard enough without having to deal with all this other stuff.

  • Turulato

    Well, this isn’t rllaey related (well, it’s kind of related, which is why I’m writing it), but on Wednesday I finally made an appointment with an adult endocrinologist. I’m 20 years old and I still go the pediatric endocrinologist. The receptionist asks me during the phone call, “Type 1 or Type 2?” and it just floored me. NO ONE has ever asked me to tell them what type I was because I’ve always 1) been a kid or 2) been at the pediatric endocrinologist, where 99.9% of us are Type 1s. It was creepy. I almost felt insulted that she would even ask me, but then I realized I was talking to an adult endocrinologist now and they deal with both types equally. It was very strange. End rant.