Zantac – the medication often seen on television commercials and long touted as one of the leading over-the-counter remedies for heartburn – has been pulled from all shelves by the U.S. Food And Drug Administration (FDA) due to the confirmed presence of a carcinogenic (cancer-causing) compound. The nationwide recall will go into effect immediately, and as a result all manufacturing of Zantac will cease.
Because Zantac was so popular and so heavily advertised for so many years, it is possible that millions of Americans were potentially exposed to a carcinogenic compound. Even worse, tests have shown that there could be tremendously high amounts of this cancer-causing compound in each dose of Zantac. If you believe that yourself or a loved one has contracted cancer as a result of repeated use of Zantac, contact an attorney from Altman & Altman LLP right away to discuss possible legal action.
What is dangerous about Zantac?
Zantac is simply a brand name used to market the medication. The active compound in Zantac is ranitidine, which is used to fight acid buildup in the stomach and esophagus – the cause of heartburn. However, recent tests have confirmed that Zantac also contains N-Nitrosodimethylamine (NDMA), which has long been classified as a potential carcinogen in humans by the FDA.
Exposure to NDMA has been linked to various diseases, from multiple types of cancer (including the most potentially deadly forms and less severe forms) to liver failure. Although testing the effects of NDMA on humans has been limited in scope, the FDA and independent studies have long identified NDMA as potentially harmful to humans through observation of its negative effects on lab mice. More pointedly, NDMA is a compound commonly found in industrial grade pesticides and even in high octane fuels.
How much NDMA is in Zantac?
According to Valisure, the Connecticut pharmaceutical company that made the initial discovery of NDMA, there were extremely high levels of the compound in the batches of ranitidine they tested – regardless of the dosage or where the drug was manufactured. They reported that there was as much as 3 million nanograms of NDMA in each Zantac tablet – which is over 31,000 times more than the recommended daily intake of 96 nanograms set by the FDA.
Unfortunately, the FDA did not immediately take heed from Valisure’s testing, and Zantac continued to be manufactured and sold to people across the country. It was only until this week that an independent investigation from the FDA finally convinced them to act.
What is the status of Zantac now? Should I stop taking it?
As of this week, the FDA has officially called for a full recall of Zantac products – meaning that manufacturing and sale of all variants of the drug must come to an end. This adds to a series of voluntary recalls that have occurred over the years from various manufacturers of the drug – as well as retail chains such as Walmart, Walgreens and CVS, which previously halted sale of Zantac and its generic forms.
This new recall means that anyone who regularly uses Zantac for heartburn relief should instantly stop doing so, as there is good reason to suspect it may negatively impact your health – especially if you rely on it regularly to treat heartburn and indigestion issues. As always, contact your healthcare provider with concerns you have, and with questions about what medication might work in place of Zantac. There are multiple medications, such as Pepcid, Nexium and Prilosec which have not tested positive for the presence of NDMA.
Did drug manufacturers know about this health risk?
There is some evidence to suggest that Sanofi – the manufacturer of Zantac – could have reasonably known about the possibility of Zantac being an unstable drug as far back as 2002, and that such instability could potentially result in the production of NDMA. In fact, the FDA’s most recent findings included the fact that improperly stored Zantac – for example, if it was stored at high temperatures – could especially lead to the production of NDMA.
Prior studies have found that patients taking ranitidine had large increases in the concentration of NDMA in their urine following tests. Others showed that ranitidine is a possible “precursor” to NDMA. This essentially means that the study found ranitidine is a chemical building block to the more harmful NDMA compound.
These findings suggest that there was always a chemical instability in Zantac that could potentially lead it to being dangerous, and if drug manufacturers were aware of this possibility but failed to warn consumers about it, that could mean they are liable for damages that have occurred due to the drug’s widespread use. Continue reading