Important Safety Information for Lantus®

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 Zhewitra 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.

Lantus® SoloSTAR® is a disposable prefilled insulin pen. Please talk to your healthcare provider about proper injection technique and follow instructions in the Instruction Leaflet that accompanies the pen.

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

You may have seen media coverage about a recent analysis of data indicating a potential association between LANTUS® (insulin glargine [rDNA origin] 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.

Sanofi-aventis stands behind LANTUS® and its safety profile Levitra Plus. Randomized, controlled clinical trials, which represent the gold standard of evidence, and other clinical studies, do not indicate an association of LANTUS® with cancer. With the estimated experience of nearly 24 million patient-years worldwide, LANTUS® has been used safely and effectively by adults and children (6 years and older) in the treatment of type 1 diabetes and in adult patients with type 2 diabetes since it received marketing authorization in 2000.

The American Diabetes Association (ADA) issued a statement calling for caution in interpreting the results and advising patients to continue with their insulin treatment and consult their physicians, if seeking advice.

Sanofi-aventis recognizes the seriousness of the content of the publications and is working closely with worldwide Health Authorities and experts to assess the findings and clarify any requirements to ensure patients continue to receive safe and effective treatment for their diabetes.

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

Paris, France – September 29, 2009 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) 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, including insulin analogs and Lantus® (insulin glargine [rDNA origin] injection). The research program is designed to generate more information on whether there is any association between cancer and insulin use and to assess if there is any difference in risk between insulin glargine and other insulins. This matter has been the subject of extensive discussion and debate within the scientific and medical communities for many years. While there is a consensus among leading scientists around the world regarding the difficulties of developing conclusive evidence, sanofi-aventis is committed to exploring this matter in depth, as was communicated by the company earlier this year.

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 23, 2009 – Paris, France – July 23, 2009 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that following the review of the available evidence on LANTUS® (insulin glargine [rDNA origin] injection), the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed the product’s safety and concluded that changes to the prescribing advice are not necessary.

The EMEA issued a press-release stating that they have re-confirmed their initial assessment, based on an in-depth review of existing evidence and of the recent publications of registry analyses in Diabetologia. All four registry analyses were found to have significant methodological limitations and to provide inconsistent and inconclusive results regarding a potential link between LANTUS® use and an increased risk of cancer.

Expert Statement Issued about LANTUS® Following Recent Publications in Diabetologia

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

Paris, France – July 15, 2009 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today the release of an Expert Statement by a multidisciplinary board of renowned international experts following an in-depth assessment of the recent publications of registry analyses with LANTUS® (insulin glargine [rDNA origin] injection) in Diabetologia. This board of international specialists in the field of endocrinology, oncology and epidemiology came to the conclusion, that all four manuscripts have significant methodological limitations and shortcomings, and that they provide inconsistent and inconclusive results regarding a potential link between insulin glargine use and an increased risk of cancer.