These Frequently Asked Questions (FAQs) were developed by sanofi-aventis to give
you more information about LANTUS® (insulin glargine [rDNA] injection) and the
recent studies published in Diabetologia. Patients who take LANTUS® and
have other questions or concerns should talk to their treating healthcare providers.
Is LANTUS® safe?
Should I stop taking LANTUS®?
Should doctors stop prescribing LANTUS®?
Will LANTUS® be taken off the market?
What is sanofi-aventis' response to the recent studies published
in Diabetologia?
What actions are sanofi-aventis taking in response to the studies?
Is sanofi-aventis talking with the regulatory agencies? Can the company give me an update on those
conversations?
Why were the recent studies conducted by
third parties and not sanofi-aventis?
How do the recent studies compare with the
randomized controlled studies done by sanofi-aventis?
Has sanofi-aventis studied a link between LANTUS®
and the risk of cancer?
Will patients who have been on LANTUS®
for several years develop cancer?
Are LANTUS® patients with a past history
or family history of cancer at increased risk of developing cancer?
What are the options available to LANTUS®
patients who want to switch to another medication?
Where is LANTUS® made? Is sanofi-aventis going
to change their production system as a result of the recent concerns about LANTUS®?
Is it true that Novo Nordisk sold LANTUS®
to sanofi-aventis?
Where can I find more information?
Is LANTUS® safe?
Sanofi-aventis considers LANTUS® a safe and effective way to help lower blood
sugar as part of an overall diabetes treatment plan. The most reliable scientific
tests show no link between taking LANTUS® and developing cancer. Sanofi-aventis
stands behind the safety of LANTUS®.
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Should I stop taking LANTUS®?
The U.S. Food and Drug Administration (FDA), the American Diabetes Association (ADA),
the European Medicines Agency (EMEA), and the International Diabetes Federation
(IDF) have all said that the studies recently described in Diabetologia are
not clear. They also are calling for caution in interpreting the results and advising
patients to continue with their insulin treatment and talk to their treating healthcare
providers.
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Should doctors stop prescribing LANTUS®?
Based on current data, sanofi-aventis believes that the benefits and risks of prescribing
LANTUS® have not changed. Sanofi-aventis still considers LANTUS® a safe
and effective way to help lower blood sugar as part of an overall diabetes treatment
plan.
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Will LANTUS® be taken off the market?
Based on the information we have now, there are no plans to take LANTUS® off
the market, and the leading health authorities worldwide have not recommended doing
so.
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What is sanofi-aventis' response to the recent studies published in Diabetologia?
We believe that the articles published in Diabetologia show that no definitive
conclusions can be drawn about a possible link between LANTUS® use and cancer,
as the authors of the studies themselves point out. Sanofi-aventis considers LANTUS®
a safe and effective way to help lower blood sugar as part of an overall diabetes
treatment plan.
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What actions are sanofi-aventis taking in response to the studies?
Patient safety has been and always will be our first concern at sanofi-aventis.
We take the issues raised in the recent studies very seriously. We are committed
to working with health authorities, professional groups, patient associations, and
scientific experts around the world to thoroughly evaluate the recent studies.
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Is sanofi-aventis talking with the regulatory agencies? Can the company give me an
update on those conversations?
Sanofi-aventis contacted the Health Authorities when it found out about these publications
and their potential impact on public health. All of our data and research were sent
to the leading Health Authorities. As part of our commitment to patient safety,
we regularly work with these agencies to make sure patients have the most up-to-date
safety, benefit, and risk information about all of our products, including LANTUS®.
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Why were the recent studies conducted by third parties and not sanofi-aventis?
Based on the results of our research, sanofi-aventis has never had any reason to
suspect a link between LANTUS® and cancer. Our own five-year follow-up study
with LANTUS® did not find an increased risk of cancer. No cancer risk has been
identified with LANTUS® throughout its development, so we never found cause
to conduct research about a possible link.
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How do the recent studies compare with the randomized controlled studies done by
sanofi-aventis?
The studies published in Diabetologia used a disease registry, which are
observational in nature. They did not require patient consent. The results are less
rigorous than the gold standard of randomized controlled studies.
Randomized controlled studies are designed to provide precise answers to specific
medical questions. They require prior patient consent. These studies are used to
evaluate the efficacy and safety of a drug. They evaluate the relative benefits
and risks associated with the drug in a controlled environment.
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Has sanofi-aventis studied a link between LANTUS® and the risk of cancer?
No link between LANTUS® and cancer has been identified in clinical trials or
nine years of safety data and the sanofi-aventis five-year follow-up study with
LANTUS® did not find an increased risk of cancer.
LANTUS® has been widely studied and no randomized, controlled data appear to
show an increased risk of cancer in LANTUS® users.
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Will patients who have been on LANTUS® for several years develop cancer?
We believe that the data published in Diabetologia show no definitive link
between LANTUS® use and the development of cancer, as the authors of the studies
themselves point out.
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Are LANTUS® patients with a past history or family history of cancer at increased
risk of developing cancer?
We believe that the data published in Diabetologia show no definitive link
between LANTUS® use and the development of cancer, as the authors of the studies
themselves point out.
No link between LANTUS® and cancer has been identified in clinical trials or
nine years of safety data, and the Sanofi-aventis five-year follow-up study with
LANTUS® did not find an increased risk of cancer.
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What are the options available to LANTUS® patients who want to switch to another
medication?
If you are a LANTUS® patient, you should speak with your treating healthcare
provider if you have questions regarding your treatment with LANTUS®. Sanofi-aventis
considers LANTUS® a safe and effective way to help lower blood sugar as part
of an overall diabetes treatment plan.
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Where is LANTUS® made? Is sanofi-aventis going to change their production system
as a result of the recent concerns about LANTUS®?
LANTUS® is manufactured in Germany by sanofi-aventis. We currently have no plans
to change our production of LANTUS®.
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Is it true that Novo Nordisk sold LANTUS® to sanofi-aventis?
No, LANTUS® is the result of the research carried out within the sanofi-aventis
Group.
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Where can I find more information?
You should speak with your treating healthcare provider if you have questions or
concerns. Also, check back with us at factsaboutlantus.com for the most up-to-date
information about LANTUS®. The following associations are good sources of information
about the treatment of diabetes:
Food and Drug Administration
American Diabetes
Association
American Association
of Clinical Endocrinologists
European Medicines
Agency
International Diabetes
Federation
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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.