Settlement of cancer allegations against blockbuster drug

French pharmaceutical company Sanofi has reached a principal agreement in the US on around 4,000 of the cases in which its now withdrawn blockbuster heartburn drug Zantac allegedly had caused cancer.

The settlement is preliminary and is not an admission of liability on Sanofi’s part. The company said it agreed to the settlement in order to avoid the expense and ongoing distraction of the litigation.

“Sanofi has vigorously defended the Zantac litigation since the outset and will continue to do so,” the company said in a statement.

Financial details have not been disclosed, but the agreement reportedly covers most of the lawsuits against the company in US state courts, in addition to the large number of cases still pending in the state of Delaware.

In the Delaware Supreme Court, nearly 70,000 lawsuits filed against Sanofi and several other pharmaceutical companies, such as GSK, Pfizer and Boehringer Ingelheim in the Zantac case, are still pending. The parties are still waiting for a judge to decide whether there is sufficient scientific support for the claim that Zantac causes cancer, according to Reuters.

Zantac, with the active ingredient ranitidine, was authorised in 1983 and five years later became the world’s best-selling drug. It was initially marketed by a predecessor of GSK but was subsequently sold to, in turn, Pfizer, Boehringer and Sanofi.

The drug was designed to reduce stomach acid production and was used, among other things, to treat stomach ulcers.

However, by 2019, it was revealed that over time and under certain conditions, ranitidine can be converted into nitrosamines, or NDMA, a substance suspected to be carcinogenic based on animal studies.

The drug was withdrawn in Europe and Sweden in 2019, and in the US, the FDA made a similar decision the following year, as reported at the time by Life Science Sweden. Meanwhile, an increasing number of lawsuits were filed by people who claimed that their cancer might be linked to Zantac.

The pharmaceutical companies maintain that there is no evidence that Zantac exposed patients to harmful levels of NDMA.

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