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Additional Resources about LANTUS® (insulin glargine [rDNA] injection)

Food and Drug Administration Statement

Early Communication About Safety of LANTUS® (insulin glargine)

7/1/2009

FDA 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®.
See http://www.Diabetologia-journal.org/cancer.html.

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. Patients should also contact their healthcare professional if they have concerns about the medicines they are taking.

Please read the full statement from the FDA

Pharmaceutical and Medical Devices Agency, Japan

On the basis of currently available data regarding a possible increased risk of cancer associated with insulin preparations, taking into account the expert’s discussion, the PMDA has evaluated the necessity of implementing new safety measures, and has concluded that, at this time, no additional safety measures are needed for insulin preparations including insulin glargine.

Download full report

American Diabetes Association Statement

ADA Statement on Insulin Glargine and Cancer

ALEXANDRIA, VA, Jun 26, 2009 (MARKETWIRE via COMTEX) --
Diabetologia, the journal of the European Association for the Study of Diabetes (EASD), published a series of research papers today examining a possible link between insulin glargine (brand name, LANTUS®) and cancer.

Please read the full statement from the American Diabetes Association

International Diabetes Federation Statement

Statement from International Diabetes Federation Related to Studies Published in Diabetologia Suggesting Possible Link Between Insulin Glargine and Cancer

The International Diabetes Federation (IDF) today called for urgent assessment and responses from regulatory authorities into a possible link between the use of insulin glargine (an insulin analogue) and increased risk of cancer based on findings published on 26 June, 2009 in Diabetologia, the journal of the European Association for the Study of Diabetes (EASD).

Please read the full statement from the International Diabetes Foundation

American Association of Clinical Endocrinologists Statement

AACE Response to Insulin Glargine Articles in Diabetologia

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) and the development of certain malignancies.

Please read the full statement from the AACE

The Endocrine Society Statement

The Endocrine Society Responds to Recent Insulin Glargine (LANTUS®) Study with Recommendations for Patients and Physicians

Five articles recently posted 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.

Please read the full statement from the The Endocrine Society

Expert Statement

Four retrospective epidemiological studies recently published in Diabetologia have drawn attention to the known association between obesity, diabetes, and cancer. These studies arose from concern that insulin glargine might pose particular risks for patients using it for treatment. However, the studies have serious methodologic limitations, as well as inconsistencies within and between them, and so do not establish a link between the use of glargine and an increased risk of cancer or other safety issues for patients with diabetes.

Download full Expert Statement

From Diabetologia

Combined randomised controlled trial experience of malignancies in studies using insulin glargine

Recent publications of data extracted from population registries have suggested a possible relationship between treatment with insulin glargine and increased incidence of cancer/breast cancer. The aim of the present study was to investigate this possible relationship using data from the manufacturer’s (sanofi-aventis) pharmacovigilance database.

Read the full study

Important Safety Information for Lantus® (insulin glargine [rDNA] 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. 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

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. Insulin devices and needles must not be shared between patients.

The most common side effect of insulin, including Apidra®, is low blood sugar (hypoglycemia), which may be serious. 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

Prescription Apidra® is for adults with type 2 diabetes or adults and children (4 years and older) with type 1 diabetes to improve blood sugar control. Apidra® 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.

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Additional Resources

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.

LEARN MORE

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.

LEARN MORE

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.

LEARN MORE

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.

LEARN MORE

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.

LEARN MORE

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.

LEARN MORE

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.

LEARN MORE