FDA reviewing Lantus safety data re: possible risk for cancer in patient with diabetes

July 8th, 2009 by Scott Thomas

Lantus (insulin glargine)
Audience – Diabetes healthcare professionals, patients

FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects.

FDA is currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus. Discussions are also ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. FDA will communicate the results on its ongoing review to the public, as appropriate, as our review continues.

The FDA encourages both healthcare professionals and patients to report side effects from the use of insulin glargine to the FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/medwatch/report.htm.

Read the complete MedWatch Safety summary, including a link to the Early Communication and supporting documents, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170089.htm

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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This entry was posted on Wednesday, July 8th, 2009 at 5:23 pm and is filed under News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

  • Ms. Jacobson,

    Thank you for sharing your courageous story. We wish you the very best. Please keep us posted and let us know if there is anything we can do to help.

    Sincerely, Scott Thomas
  • J.E.Jacobson
    I am a 63 year old female diagnosed with a rare small cell carcinoma June 29/09 after using Lantus long acting insulin since Oct/08. I saw my
    Doctor July 10/09. She told me she had just recieved the literature or study that questions Lantus of causing cancer cell growth. she immediatly took me off Lantus and ordered long acting Levemir instead. I remain on Novo-
    rapid for sliding scale purposes. Her words,"keep your eyes open for any class actions for lantus ,as I believe you fit squarely into that category.The lesion is still small but too close to the urethra and resection is not advisable apparently according to the gyne oncologist I recently consuslted with.I was advised that I was eligible for the harshest possible treatment of 4 types of chemo and very very extensive radiation over 5 weeks followed by a radiation implant...all this treatment is done over a 6 month course.

    I have chosen to decline aggressive treatment as it would most likely kill me.
    My decision possibly coloured by my being a retired R.N. which gave me a front row seat tomore than a few people who desparately sought to live with
    hope and while, I applaud their heroism and bravery, I have decided to try to
    Live with Cancer as fully and joyfully as I can untill I can't and then I will pray for kind caregivers and good palliative treatment and attempt to muster as much dignity as I can despite the pure indignity and irony of " I thought for sure it would have been my Heart".
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