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FDA Drug Safety Podcast for Healthcare Professionals: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer

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Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information. On January 12, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public about its ongoing safety review of Lantus (insulin glargine) and a possible increased risk of cancer. Lantus is a long-acting modified version of human insulin (insulin analog) used to control blood sugar in patients with Type 1 and Type 2 diabetes.

In July 2009, FDA issued an Early Communication About Safety of Lantus to inform the public that it was reviewing four published observational studies, three of which suggested an increased risk of cancer associated with the use of Lantus. FDA has completed its review of the studies and has determined that the evidence presented in these studies is inconclusive due to methodological limitations.

The duration of patient follow-up in all four studies was shorter than what is generally considered necessary to evaluate cancer risk from drug exposure. Also, the four studies provided limited information on patients' use of insulin products. Additionally, some of these studies did not take into account whether the patients used any anti-diabetic drugs before the study time period or whether there were any changes in how patients used these drugs during the study period. Furthermore, risk factors for cancer, such as smoking, family history of cancer, and obesity, may not have been adequately controlled for in these studies. This prevents our ability to attribute the observed cancer risk solely to Lantus.

In addition to the four published observational studies, FDA has reviewed results from the Evaluation of Diabetic Retinopathy Progression in Subjects with Type 2 Diabetes Mellitus Treated with Oral Agents Plus Insulin trial, which was a five-year, randomized trial comparing Lantus to NPH insulin in individuals with Type 2 diabetes. A post-hoc evaluation (examining the data after the trial concluded for outcomes that were not identified a priori) of the occurrence of cancer was conducted. The safety population consisted of over 500 patients per treatment arm with a median exposure of approximately five years. The overall occurrence of all cancers was 5.8% in the Lantus arm versus 9.3% in the NPH insulin arm. The odds ratio for all cancers was 0.60. The results did not support an increased risk of cancer associated with Lantus in comparison to NPH insulin; however, the study was not designed or powered to evaluate cancer outcomes and these outcomes were not verified in medical records or reviewed by cancer experts.

FDA continues to work with the manufacturer of Lantus and other scientists to further evaluate the safety of Lantus. The manufacturer's ongoing Outcome Reduction with Initial Glargine Intervention, or ORIGIN, clinical trial has been amended to adjudicate all cases of cancer occurring during the trial. The ORIGIN trial is designed to determine if treatment with Lantus to reduce fasting plasma glucose to 95 mg/dL or less would reduce the incidence of cardiovascular events in patients with pre-diabetes or early diabetes versus standard care. An interim review of the data by an independent data monitoring committee did not show evidence of a signal for increased cancer risk. Results from the ORIGIN trial are expected at the end of 2011.

FDA is aware that the manufacturer plans to conduct three epidemiological studies to further evaluate cancer risk associated with the use of Lantus. Results from the epidemiological studies are expected by the end of June 2011.

FDA is also working with the U.S. Department of Veterans Affairs, the VA, to decide whether to use the VA's patient database to further evaluate any potential cancer risk with Lantus.

FDA will communicate important new data on this issue when they become available.

 At this time, FDA recommends that  Healthcare Professionals be aware that:

  1. FDA has not concluded that Lantus increases the risk of cancer. The Agency is continuing to review this safety concern and will update the public when additional information is available.
  2. Recommendations in the drug label should be followed when prescribing Lantus.
  3. Adverse events involving Lantus should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening.  The FDA is committed to keeping healthcare professionals informed of the latest safety information.  To learn more about this Drug Safety Communication, go to www.fda.gov/Drugs.  If you have drug questions, you can reach us at: druginfo@fda.hhs.gov.


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