FDA Pulls Zantac from Market Due to Cancer Concerns

In a widely expected move, the Food and Drug Administration (FDA) has asked companies to stop selling the heartburn drug Zantac and its generic equivalent ranitidine because of its association with a cancer-causing contaminant N-nitrosodimethylamine, or NDMA that can build up in the drug over a period of time. In addition to informing companies that they should pull the product from their shelves, the FDA told consumers that they should stop taking the over-the-counter drug.  Those who have a prescription should consult with their physician prior to ceasing use of the medicine.

Sanofi, the manufacturer of Zantac, responded to the FDA announcement by stating that it had recalled the product in October, and that all retailers and consumers were previously instructed to return or destroy the product.

An online pharmacy’s investigation of the drug prompted the FDA to look into the drug’s potential carcinogenic qualities. According to the NY Times, “At the time of its testing, Valisure speculated that the source of the contaminant was the result of the “inherent instability” of the ranitidine molecule, which can degrade under certain conditions, such as high temperatures, to create NDMA.

But the F.D.A. initially pushed back against the pharmacy’s testing methods, saying the results were invalid because the pharmacy had heated the product, which created the higher levels of NDMA.

On Wednesday, however, the agency appeared to confirm Valisure’s findings, saying that “the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.”

Our law firm has been a leader in consumer advocacy in terms of dangerous drugs and Zantac is one of those drugs. We are currently speaking with potential clients or their family members who have been injured, sometimes fatally, because they took the drug for a protracted period of time.  Sanofi knew or should have known that Zantac was a dangerous drug and posed a clear and present danger to the health and welfare of the public.  The manufacturers of Zantac were more interested in profits than people.  They knew about these dangers as early as the 1980’s but failed to disclose the findings to the health community, doctors, or the general public.  Use of Zantac poses a serious public health risk. 

Because Zantac was a popular drug that was aggressively marketed, it is quite possible that thousands of people may have been adversely affected by prolonged use of the drug.  When Zantac was first produced in 1983 by the company now known as GlaxoSmithKline, it was intended for short-term use.  At least, that was what the company had submitted to the FDA.

If you or a loved one have been prescribed or purchased over-the-counter Zantac or its generic ranitidine and suffered serious injury such as cancer, call the Rheingold Law Firm for a free initial consultation.