FDA acknowledges four recent studies that observed the use of the insulin, Lantus and possible risk for cancer. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. See http://www.diabetologia-journal.org/cancer.html.

Currently, the FDA recommends that patients consult their doctor before stopping their insulin therapy. Patients should not stop their therapy on their own. Uncontrolled blood sugar levels can pose both immediate and long-term serious adverse effects.

Similar to human insulin, Lantus is used to control blood sugar in people with Type 1 and Type 2 diabetes. Lantus is a long-acting insulin that is only approved for once-a-day dosage delivered by under the skin injections.

In all four studies, the length of patient follow-up was shorter than what is necessary to evaluate for cancer risk from drug exposure. Further, the studies were inconsistent within themselves and with each other, which raises the question if there really is an association between Lantus and cancer. Additionally, differences in patient characteristics in the various treatment groups may have contributed to a finding of increased cancer risk.

Nonetheless, FDA is reviewing the safety data for Lantus to better understand the risk, if any, for cancer associated with use of Lantus. FDA is also communicating with Lantus if any additional studies are needed to evaluate the safety and efficacy of Latus.

FDA requests that any adverse events associated with Lantus be reported to their MedWatch program.

he FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders

Labels: cancer, diabetes, FDA, insulin, Lantus