Drug Safety Developments

Sanofi rebuffs renewed Lantus cancer worries

Quoted from http://www.reuters.com/article/2011/12/07/us-sanofi-lantus-idUSTRE7B60NA20111207

Sanofi rebuffs renewed Lantus cancer worries

By Ben Hirschler

LONDON | Wed Dec 7, 2011 6:27am EST

LONDON (Reuters) - A Swedish study has rekindled concerns about a possible link between Sanofi's top-selling insulin drug Lantus and cancer, but the French drugmaker said on Wednesday the observational research was seriously flawed.

It said separate data would be presented on December 8 showing no increased risk of cancer among patients taking its $4.7 billion-a-year product.

The Swedish research, which looked at the medical records of 23,000 people in the southwest of the country in an attempt to find common links to cancer, found an apparent doubling of cancer risk in those taking Sanofi's long-acting insulin.

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Sanofi to probe cancer link with insulin use

Quoted from http://www.reuters.com/article/rbssHealthcareNews/idUSLT1221420090929

Sanofi to probe cancer link with insulin use

PARIS, Sept 29 (Reuters) - Sanofi Aventis on Tuesday launched a research plan to probe the safety of insulin, including its Lantus diabetis drug.

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 -- such as Lantus -- and other insulins.

Sanofi-Aventis said its scientific programme and studies will be initiated in the coming weeks.

Timelines for study completion and data generation will vary depending on each type of study.

In June, the European Association of the Study of Diabetes journal Diabetologia published a critical study discussing the drug at its annual meeting.

Prescription data showed demand for the long-acting insulin was holding up, despite the release of studies suggesting a possible link between Lantus and cancer, while U.S. and European regulators have both backed the product. (Reporting by Marcel Michelson; Editing by Hans Peters)

No Cancer Worry On Sanofi Diabetes Drug - Regulator

Quoted from http://online.wsj.com/article/BT-CO-20090723-715421.html

No Cancer Worry On Sanofi Diabetes Drug - Regulator

JULY 23, 2009, 12:46 P.M. ET

LONDON (Dow Jones)--The European Union drug regulator Thursday ruled out the probability that Sanofi-Aventis SA's (SNY) diabetes treatment causes cancer and said that the drug could be sold and prescribed as usual.

In a ruling expected to boost the French company's shares, the European Medicines Agency said that evidence of a link between the drug and cancer was inconclusive based on the available data.

The treatment, marketed by Sanofi under the brand name Lantus, is an artificial form of insulin, also known as an insulin analogue, and it has been widely used since 2000. Older forms of insulin are known as human insulin.

"Following review of all available information on a possible relationship between insulin analogues ... and the risk of cancer, the available data does not provide a cause for concern and that changes to the prescribing advice are, therefore, not necessary," European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded.

The EMEA would like further research done in the area and has asked Sanofi to help.

Sanofi welcomed the regulator's statement, which it said confirmed the drug's safety.

"This is important and reassuring information for patients receiving Lantus," Jean-Pierre Lehner, Sanofi's chief medical officer, said in an emailed statement.

The company said it would take action to develop further research.

Shares in Sanofi closed up 1.2% at EUR46.34 before the EU ruling.

Sanofi says experts find Lantus studies flawed

Quoted from http://www.reuters.com/article/rbssHealthcareNews/idUSLF73372620090715

Sanofi says experts find Lantus studies flawed

Wed Jul 15, 2009 5:18am EDT

By Helen Massy-Beresford and Ben Hirschler

PARIS/LONDON, July 15 (Reuters) - Sanofi-Aventis said on Wednesday a group of independent experts had concluded that studies highlighting a possible link between its Lantus diabetes drug and an increased risk of cancer were flawed.

A multidisciplinary board of experts from the United States, France, Germany, Italy and Canada reached the conclusion after being asked by the French drugmaker to assess four studies published last month in the medical journal Diabetologia.

They found "significant methodological limitations and shortcomings" and said the results were "inconsistent and inconclusive".

But they added the important scientific questions raised called for further analysis of existing data on Lantus, as well as more basic and clinical investigations.

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5 Risks Linked to Diabetes Medications Like Lantus, Avandia, Actos - US News and World Report

Quoted from http://health.usnews.com/articles/health/diabetes/2009/07/07/5-risks-linked-to-diabetes-medications-like-lantus-avandia-actos.html

5 Risks Linked to Diabetes Medications Like Lantus, Avandia, Actos

Cancer, heart failure, fractures, and eye and liver problems among some diabetes drugs' possible risks

By January W. Payne

 

Posted July 7, 2009

For the 200 million diabetics worldwide, the past few years have brought some disturbing findings about risks that may be associated with certain diabetes drugs. Recent concerns that Avandia (rosiglitazone) might cause cardiovascular problems, for example, have led some experts to call for it to be pulled from the market, although it remains available today. And in late June, studies published online by the journal Diabetologia raised questions about a possible link between the diabetes medication Lantus (insulin glargine) and an increased risk of cancer.

The safety worries about these diabetes medications come from scientific studies of varying designs. Some of the research, like that on Lantus and cancer, is based on observational data, which is not always reliable. The concern about Avandia, on the other hand, comes from clinical trials, which are the gold standard of research, and meta-analyses.

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FDA plays down cancer link with Sanofi's Lantus

Quoted from http://www.reuters.com/article/healthNews/idUSTRE5605K620090701

FDA plays down cancer link with Sanofi's Lantus

Wed Jul 1, 2009 4:18pm EDT

By Lewis Krauskopf and Susan Heavey

NEW YORK/WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Wednesday cast doubt on recent studies that suggested possible cancer risk with Sanofi-Aventis' widely used Lantus diabetes drug, boosting investor confidence in the blockbuster product....

In a communication posted on its website, the agency questioned four recently published studies over the cancer link, saying they did not track patients long enough to properly evaluate any such risk from the drug.

Additionally, the FDA said, "inconsistencies in findings within and across individual studies raise concerns as to whether an association between the use of (Lantus) and cancer truly exists."

It added that there may be differences in the patients studied that could have contributed to the studies' findings.

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Study: Sanofi’s Lantus Insulin Has Possible Cancer Link

Quoted from http://blogs.wsj.com/health/2009/06/26/study-sanofis-lantus-insulin-has-possible-cancer-link

Study: Sanofi’s Lantus Insulin Has Possible Cancer Link

By Shirley S. Wang

New data published today suggest that there is a “possible link” between French drug maker Sanofi-Aventis’s Lantus insulin for diabetes and a higher risk of cancer, according to Diabetologia, the journal in which the data were published.

The European Association for the Study of Diabetes, which publishes the journal, also made an “urgent call for more research” studying Lantus and cancer. It said the concern was specific to artificial insulin like Lantus, not human insulin, and urged patients not to stop taking their insulin but to consult their doctor if concerned.

Of the four studies published, the one that first prompted concern was conducted on 127,000 insulin-treated patients from a German insurance database. Researchers found that one additional person out of every 100 who used Lantus for an average of 1 1/2 years compared with human insulin was found to have cancer compared with those using human insulin. The higher the dose of Lantus used, the greater the risk of cancer, they said.

But results from three other studies, conducted in Sweden, Scotland and the U.K., were mixed. One also found a positive link while the other two showed no statistically significant link.

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Sanofi may suffer, whatever final Lantus verdict

Quoted from http://www.reuters.com/article/euPrivateEquityNews/idUSTRE55P2PM20090626

Sanofi may suffer, whatever final Lantus verdict

Fri Jun 26, 2009 7:33am EDT

By Ben Hirschler, European Pharmaceuticals Correspondent

LONDON (Reuters) - The history of past drug scares suggests concerns over the safety of Sanofi-Aventis's diabetes treatment Lantus will hit sales, whether or not a suggested link to cancer proves real.

Shares in the French drugmaker sank 7 percent on Friday, extending losses from the previous session, on growing concern that researchers are about to publish a damaging analysis of the company's modern, or analog, insulin drug.

"Our information is that indeed a study is likely to be published soon raising the possibility of a link between Lantus use and a certain cancer type," Sanford Bernstein analyst Tim Anderson said in a research note.

"We understand this will not come out in a small medical journal, but rather one of the major medical journals and it will be the first time that such a high-profile analysis has been published linking the drug to cancer in humans."

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