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New court filing alleges Sanofi destroyed emails relating to Zantac recall

Drugmaker began recalling heartburn drug in 2019 after link to probable human carcinogen

Sanofi has been accused of destroying internal emails relating to the recall of its heartburn drug Zantac in 2019, according to lawyers representing former patients suing the French pharma company in the US.

Lawyers for over 70,000 patients in the US who are suing Sanofi noted that the mishandling of certain emails relating to the recall “resulted in the delay and/or postponement of many key Sanofi depositions”.

Among the deleted emails are those from Michael Bailey, Sanofi’s head of regulatory affairs for the US consumer healthcare division, according to Bloomberg.

The lawyers representing the former patients have asked a judge to allow them more time to prepare for the first trials, adding that the missing emails could have been used as key evidence showing that Sanofi allowed a suspected carcinogen to contaminate Zantac.

Sanofi has begun an internal probe relating to the missing emails and is expected to deliver a report to a judge overseeing the Zantac court filing in August.

“Although Sanofi has already provided hundreds of thousands of pages of relevant discovery to the plaintiffs, Sanofi has voluntarily disclosed that certain emails requested by plaintiffs were not preserved as intended,” said Ashleigh Koss, a US spokeswoman for Sanofi.

“There was no intentional destruction of data. Sanofi is working to obtain as much of the data as possible from alternative sources. This issue has no impact on the strong defences Sanofi has in this litigation, and the company remains fully confident in the safety of Zantac,” she added.

Sanofi, along with other drugmakers manufacturing Zantac including GlaxoSmithKline and Novartis, began recalling the over-the-counter medication in 2019 following concerns that the drug contained a potentially cancer-causing impurity.

At the time, the US Food and Drug Administration (FDA) said that some ranitidine medicines, including Zantac, contain low levels of N-Nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. This substance could cause cancer and is a known environmental contaminant.

In April 2020, the FDA then formally requested the removal of all ranitidine products from the market, following an ongoing investigation into NDMA.

The regulatory agency said that the impurity found in some ranitidine products increases over time and when stored at higher room temperatures, potentially resulting in ‘consumer exposure to unacceptable levels of this impurity’.

“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, acting commissioner of the FDA and previous director of the FDA’s Center for Drug Evaluation and Research.

Article by
Lucy Parsons

13th May 2021

From: Regulatory



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