Sanofi’s troubles stemming from the 2019 recall of Zantac appear to be far from over.
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Sanofi‘s troubles stemming from the 2019 recall of Zantac appear to be far from over.
More than 70,000 former patients are suing the French drug maker for allegedly deleting internal emails that could have played a critical role in proving its part in the scandal. Some of the missing emails belonged to Michael Bailey, the head of regulatory affairs for Sanofi’s U.S. Consumer Healthcare division.
Lawyers for the former patients claim the emails could have been key evidence to show that Sanofi, along with other companies, permitted Zantac to be tainted with a suspected carcinogen.
The missing emails have “resulted in the delay and/or postponement of many key Sanofi depositions,” according to the lawyers.
Court filings show that Sanofi is conducting an internal investigation regarding the deleted emails.
According to Bloomberg, Ashleigh Koss, a U.S.-based spokeswoman for Sanofi, made a statement via email on Tuesday.
“Sanofi is working to obtain as much of the data as possible from alternative sources,” Koss said. “This issue has no impact on the strong defenses Sanofi has in this litigation, and the company remains fully confident in the safety of Zantac.”
Patients and health care professionals were first made aware of the U.S. Food and Drug Administration (FDA)'s concerns about N-nitrosodimethylamine (NDMA), a nitrosamine impurity, being present in ranitidine medicines in September 2019. Zantac, along with other over-the-counter and prescription medications, was being looked into.
Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach.
At the time, the FDA was not telling patients to stop taking the medications, but rather was assessing whether or not the low levels of NDMA present in them would pose a risk to patients.
Despite the FDA not implementing any product pulls at the time, Sanofi and other ranitidine product manufacturers voluntarily recalled some lots from shelves out of an abundance of caution.
Fast-forward to April 2020, and the FDA was asking manufacturers to immediately withdraw all ranitidine-based drugs from the market.
The regulatory agency had determined that some ranitidine products’ impurity increases over time when stored above room temperature. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit, the FDA said.
“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, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
