Until the spring of 2020, Zantac and generic and store brand ranitidine-based drugs were widely used to treat gastrointestinal issues such as ulcers, heartburn, and gastroesophageal reflux disease (GERD). The drug was very popular across decades. Millions of Americans and many others around the world took Zantac and other ranitidine products, until a quality assurance check by an independent laboratory called Valisure set off alarm bells in 2019. The company reported that dangerous levels of a substance called NDMA (N-Nitrosodimethylamine), which has been linked to multiple types of cancer.
That report triggered an investigation by the U.S. Food & Drug Administration (FDA), and in April of 2020, the FDA requested the recall of Zantac and other products containing ranitidine. The U.S. wasn’t alone in taking these measures. Several other countries, including the European Union (EU), have banned or severely restricted sales of ranitidine. Canada has not banned ranitidine, but has imposed an extensive sampling and testing protocol that has resulted in multiple recalls.
As of mid-December, 2021, ranitidine is still off the market in the United States, and 1,799 lawsuits are pending against Zantac manufacturers in multidistrict litigation (MDL) in the U.S. District Court for the Southern District of Florida. Additional cases are pending in state courts around the country, and new claims continue to be filed.
Meanwhile, one company has been working to rehabilitate ranitidine.
EU Grants Approval to One Ranitidine Manufacturer
In July, 2021, the European Directorate for the Quality of Medicines (EDM) issued a new CEP (certificate of suitability) to India-based drug company Solara Active Pharma for ranitidine hydrochloride. The company submitted data to the EDM to demonstrate that it had improved the production process and installed safeguards that significantly reduce the risks of NDMA formation during and after production of the substance.
While Solara’s stock prices got an immediate boost, their prospects with the reintroduction of ranitidine into worldwide markets didn’t. Because the instability that leads to the increase in NDMA is a characteristic of ranitidine, some experts have warned that while the improved processes may create a better starting point, the substance may still increase after it’s manufactured–even after a patient swallows the pill.
Several previous manufacturers of ranitidine-based drugs, including Zantac manufacturer Sanofi, said they had no plans to resume production. Earlier this year, Sanofi introduced Zantac 360. The new product is recommended for treatment of the same types of conditions as the original, but the active ingredient has been replaced with famotidine.
One Manufacturer Re-Evaluating Ranitidine
UK-based Accord Healthcare announced in September that it was assessing the possibility of bringing back ranitidine. The company said the decision hinged in large part on identifying a source of the active ingredient with safe and reliable production processes.
Even if Accord moves forward, there is likely a long road ahead for ranitidine, which is still not approved for sale in the UK or the United States.
In addition to uncertainty about how the drug might behave after it leaves the manufacturer, any drug company considering resuming production of ranitidine-based products must consider the negative publicity associated with the original Zantac and whether consumers would be willing to take ranitidine-based drugs–or physicians to prescribe them.
How Will These Changes Affect Zantac Litigation?
Whether ranitidine-based drugs for heartburn, GERD, and other gastrointestinal issues return to the market or not, these new developments should have little or no impact on pending litigation. Fixing the problem after the fact does not relieve a company of liability for a dangerous drug, or for failure to warn consumers and medical professionals of known risks. At the same time, the fact that the companies have altered the process generally can’t be used against them. For instance, plaintiffs are generally prohibited from introducing evidence of this type of improvement to help prove that there was a problem with the previous version.
If you have been diagnosed with cancer and took Zantac or another ranitidine-based product for an extended period, you should speak with an attorney handling Zantac litigation right away. The time to file a claim is limited, and may be difficult to determine without knowledgeable guidance.
You can take the first step right now by filling out the contact form on this site.
If you’ve been diagnosed with cancer after taking Zantac or lost a loved one, you’re probably wondering when the ranitidine cancer cases will start moving forward. Here’s what you need to know.