When an online pharmacy discovered the presence of a carcinogenic contaminant in batches of the heartburn medication Zantac it was selling, the find triggered a global recall of the drug. Now, details are coming to light that the presence of the contaminant may not have been as much of a surprise to Sanofi; the drug’s manufacturer, as was first indicated.
Zantac, otherwise known by its chemical name ranitidine, was incredibly popular. As the de facto standard in heartburn treatment, the drug was available in both prescription strength and over the counter. And, as one could imagine, it was a cash cow for Sanofi.
That all came crashing down when online pharmacy Valisure, a pharmacy known for independently testing all the products it sells for purity and quality, found traces of NDMA in Zantac. The find resulted in Zantac being pulled from shelves all over the world, with the United States lagging weeks behind as the FDA took its usual “wait-and-see” approach to the situation.
Studies would later indicate that the contamination may have come from ranitidine itself. The drug breaks down over time and, when exposed to high temperatures like those involved in shipping containers or other environments where the climate is unregulated, the breakdown can be accelerated. One of the byproducts of that breakdown is NDMA.
It is now believed that Sanofi may have known about the risks of ranitidine and systematically destroyed emails on company servers about those risks. That destruction, according to lawyers for over 70,000 Zantac plaintiffs, “has resulted in the delay and/or postponement of many key Sanofi depositions.”
Sanofi denies the allegations and, in an email to drug news website Fierce Pharma, asserts that they “did not intentionally destroy any emails related to the Zantac litigation” and that “any suggestion to the contrary is false.”