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Sanofi-aventis' Response to Recent Analysis of Data on LANTUS® (insulin glargine [rDNA] injection)

You may have seen media coverage about a recent analysis of data indicating a potential association between LANTUS® (insulin glargine [rDNA] injection) use and cancer. As the authors of the studies themselves note, the results are inconclusive and inconsistent.

Patient safety is always the primary concern of sanofi-aventis. We will continue to work to vigorously monitor the safety of LANTUS® in close collaboration with regulatory agencies and scientific experts.

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Dr. Paul Chew, Chief Science Officer/Chief Medical Officer, sanofi-aventis U.S.

LATEST NEWS

Paris, France – September 29, 2009

Sanofi-aventis Launches Major Insulin Research Program in Partnership with the International Scientific Community

Sanofi-aventis announced today the company's action plan to provide methodologically robust research that will contribute to the scientific resolution of the debate over insulin safety.




Paris, France – July 23, 2009

Sanofi-aventis Welcomes the European Medicines Agency's Statement on LANTUS® Safety

Based on existing evidence CHMP (the EMEA's Committee for Medicinal Products for Human Use) concludes that no changes to the prescribing advice are necessary




Paris, France – July 15, 2009

Expert Statement Issued about LANTUS® Following Recent Publications in Diabetologia

Leading international experts conclude that these analyses present inconclusive and conflicting data




Bridgewater, NJ – July 6, 2009

5-year Study Published in Diabetologia Demonstrated Long-Term Safety of LANTUS® Compared to NPH

Long-term study found no increased progression of retinopathy in LANTUS® over NPH treatment regimen




Bridgewater, NJ – June 26, 2009

Sanofi-aventis Stands Behind the Safety of LANTUS®



Important Safety Information for Lantus® (insulin glargine [rDNA origin] injection)

Do not take Lantus® if you are allergic to insulin or any of the inactive ingredients in Lantus®.

You must test your blood sugar levels while using insulin, such as Lantus®. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision.

Do NOT dilute or mix Lantus® with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Lantus® must only be used if the solution is clear and colorless with no particles visible. Do not share needles, insulin pens or syringes with others.

The most common side effect of insulin, including Lantus®, is low blood sugar (hypoglycemia), which may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. Severe hypoglycemia may be serious and life threatening. It may cause harm to your heart or brain. Other possible side effects may include injection site reactions, including changes in fat tissue at the injection site, and allergic reactions, including itching and rash. In rare cases, some allergic reactions may be life threatening.

Tell your doctor about other medicines and supplements you are taking because they can change the way insulin works. Before starting Lantus®, tell your doctor about all your medical conditions including if you have liver or kidney problems, are pregnant or planning to become pregnant, or are breast-feeding or planning to breast-feed.

Indications and Usage for Lantus®

Prescription Lantus® is a long-acting insulin used to treat adults with type 2 diabetes and adults and children (6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at the same time each day to lower blood glucose.

Do not use Lantus® to treat diabetic ketoacidosis.

Click here for additional important information for Lantus®.

Important Safety Information for Apidra® (insulin glulisine [rDNA origin] injection)

Do not use Apidra® during a low blood sugar reaction (hypoglycemia) or if you are allergic to any of the ingredients in Apidra®.

You must test your blood sugar levels while using insulin, such as Apidra®. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision. Apidra® must only be used if the solution is clear and colorless with no particles visible. Do not share needles, insulin pens or syringes with others.

Apidra®, when given by injection under the skin, should not be mixed with insulins other than NPH. Do not mix Apidra® with any insulin when used in the pump or for intravenous administration.

The most common side effect of insulin, including Apidra®, is low blood sugar (hypoglycemia), which may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. Severe hypoglycemia may be serious and life threatening. It may cause harm to your heart or brain. Other possible side effects may include low blood potassium, injection site reactions, such as changes in fat tissue at the injection site, and allergic reactions, such as itching and rash. Less common, but potentially more serious or life-threatening, is generalized allergy to insulin, including anaphylactic reactions.

Tell your doctor about other medicines and supplements you are taking because they can change the way insulin works. Before starting Apidra®, tell your doctor about all your medical conditions including if you have liver or kidney problems, are pregnant or planning to become pregnant, or are breast-feeding or planning to breast-feed.

Indications and Usage for Apidra®

Prescription Apidra® is a rapid-acting insulin for adults with type 2 diabetes or adults and children (4 years and older) with type 1 diabetes to improve blood sugar control. Apidra® given by subcutaneous injection is usually used with a longer-acting insulin. When used as a mealtime insulin, Apidra® should be given within 15 minutes before or within 20 minutes after starting a meal.

Click here for additional important information for Apidra®.



The health information contained herein is provided for general educational purposes only. Your healthcare professional is the single best source of information regarding your health. Please consult your healthcare professional if you have any questions about your health or treatment.

Additional Resources

FDA States that Study Limitations Prevent Attribution of Observed Cancer Risk to LANTUS®

On January 12, 2011, the U.S. Food and Drug Administration (FDA) issued an update to their July 2009 Early Communication About Safety of LANTUS® (insulin glargine). According to the statement, the FDA reviewed four observational studies that suggested a possible link between insulin use and cancer and has determined that the evidence presented in the studies is inconclusive, due to limitations in how the studies were designed and carried out and in the data available for analysis. The FDA stated that these limitations prevent their ability to attribute the observed cancer risk to LANTUS®.

Diabetes and Cancer: a consensus report

A consensus report, from experts who were assembled by the American Diabetes Association and the American Cancer Society, reviewed emerging evidence that suggest association between cancer incidence and diabetes, as well as certain diabetes risk factors and treatments.

Food and Drug Administration

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.

Pharmaceutical and Medical Devices Agency, Japan

On the basis of currently available data regarding an increased risk of cancer associated with insulin glargine, the PMDA has concluded that no additional safety measures are needed.

American Diabetes Association

Possible Link Between Insulin Glargine and Cancer-Research Conflicting and Inconclusive; Patients Should Not Stop Using Insulin and Should Talk to Their Doctor.

International Diabetes Federation

It is important that people needing insulin do not stop taking the drug. IDF cautioned that people with diabetes should see their doctor for advice before considering any change to their treatment.

American Association of Clinical Endocrinologists

On June 26, 2009 several articles published online in Diabetologia by the European Association for the Study of Diabetes investigated the possible relationship between use of insulin glargine (LANTUS®, sanofi-aventis U.S.) and the development of certain malignancies.

The Endocrine Society

Five articles recently published online in the medical journal Diabetologia studied the possible connection between the use of insulin glargine (LANTUS®) and the development of cancer. While one of these studies suggested an increased risk of cancer, the other four did not come to the same conclusion.

From Diabetologia

Combined randomised controlled trial experience of malignancies in studies using insulin glargine. Further investigation of the possible relationship between insulin glargine and increased levels of cancer/breast cancer concluded that insulin glargine was not associated with an increased incidence of cancer compared with the comparator group.