GlaxoSmithKline and Sanofi SA are facing more scrutiny over recent Zantac recalls.
According to separate filings with the U.S. Securities and Exchange Commission (SEC), federal prosecutors are trying to determine if the companies violated the federal False Claims Act by failing to disclose the presence of a probable carcinogen in their ranitidine-containing heartburn drugs.
“On 18 June 2020, the Group received a Civil Investigative Demand (CID) from the US Department of Justice (DOJ) seeking information related to Zantac pursuant to the False Claims Act,” GlaxoSmithKline wrote in its Q3 report to the SEC. “The Group is cooperating with the DOJ to provide this information.
Both companies must now submit information and documents to the DOJ, including applications and communications with the U.S. Food and Drug Administration (FDA) related to the development and marketing of Zantac.
For decades, millions of people have used Zantac and generic versions of ranitidine, believing the medications were safe and effective treatments for heartburn. Zantac was first brought to market by GlaxoSmithKline in the 1980s, but Sanofi later acquired the rights to market name-brand versions in the United States. Multiple generic drug makers were also approved to sell their own over-the-counter and prescription versions of ranitidine.
In September 2019, the online pharmacy Valisure informed the FDA that it had detected high levels of N-Nitrosodimethylamine (NDMA) in every sample of Zantac and ranitidine it had tested. NDMA is designated a probable human carcinogen by both the U.S. Environmental Protection Agency and the World Health Organization. Animal studies have linked the compound to various cancers, including kidney cancer, liver cancer, gastrointestinal cancer, and breast cancer.
At the time, Valisure suggested the contamination was a consequence of the ranitidine molecule’s instability, which resulted in the production of NDMA when the drug was subjected to conditions that mimicked human digestion. Emery Pharma later reported that its own testing suggested NDMA was produced when ranitidine products were exposed to high temperatures typically encountered during shipment and storage.
The FDA confirmed those findings in April and ordered all Zantac and generic ranitidine drugs recalled. By that time, many pharmaceutical companies had already taken steps to withdraw their ranitidine-containing heartburn drugs, and several major retailers, including Walmart, Walgreens, Rite-Aid, and CVS, had already pulled the products from store shelves.
More than 500 Zantac lawsuits are now pending in a multidistrict litigation underway in the U.S. District Court, Southern District of Florida, all of which allege the ingestion of ranitidine-containing heartburn drugs caused users to develop various forms of cancer. Plaintiffs further claim that Sanofi, Glaxo, and other manufacturers had long known that ranitidine could expose users to dangerous levels of NDMA but failed to disclose this risk on the product labels or through any other means.
Despite the FDA’s actions, the recent recalls, and the DOJ investigation, Sanofi and Glaxo continue to deny the allegations put forth in Zantac lawsuits.
“We stand by the long-standing science that supports the safety of Zantac OTC products, which have been used by consumers for over two decades. We are not going to comment on the specifics of ongoing litigation,” a Sanofi spokesperson recently told S&P Global Market Intelligence.