Recalls Due to Nitrosamine & Legal Action Being Taken

Last updated Sep 28, 2022 | Pharmacy Management, Pharmacy Marketing

Over the past few years, the FDA has recalled many popular drugs due to a contaminant, Nitrosamine, being found in them. Medications that have been found to include concerning amounts of nitrosamines include losartan and other ARB’s, Metformin, ranitidine, rifampin, and Chantix. Let’s talk a bit more about these recalls and what nitrosamines exactly are, what to do if a patient inquires about this recall, and the legal actions that are being taken.

What are Nitrosamines?

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Nitrosamines can be commonly found in water and foods. Examples are cured and grilled meats like bacon, certain dairy products, beers, and some fish. Exposure to nitrosamines is common for most people. 

 Per the FDA, they have worked “in collaboration with regulatory counterparts around the world, to set internationally-recognized acceptable daily intake limits for nitrosamines. If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate.” Due to these regulations, many drugs have been recalled in the past couple of years. 


What to do if a patient asks about Nitrosamines in their medication?


The FDA has a wealth of information for patients and healthcare providers regarding what to do in this situation. First off, you would want to confirm with your patients that their exact medication is part of the recalled batch. Then the FDA encourages pharmacies to urge patients to continue taking their medications and not stop them abruptly. With your patients you can look at their complete health picture and work with their prescriber to create a new treatment plan that does not contain the recalled medication. 

 If your patients are taking OTC medications with high levels of nitrosamines, encourage them to switch to a different OTC class of medications or choose a manufacturer that has not been affected.


Legal Action Occurring


With many medications being recalled and patients exposed for long periods of time to levels of nitrosamines deemed unsafe, legal action is being taken. 

 Per, “A recent report from Morgan Stanley says trial judgments over nitrosamines against the makers of Zantac, including GSK and Sanofi, could reach $45 billion alone.” 

 Additionally they have stated “A trial against Zantac’s manufacturers is scheduled to begin in California in February, and others will follow later in 2023.”


Using Technology to Alert your Patients of What to to in a Recall Situation

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We have many technology offerings that can assist in educating patients of what to do if their medications are included in a recall. A few options where you can place recall information are:

With recalls of Nitrosamine occurring to such a widespread degree, it is important pharmacies are equipped with the information to not only handle the recall but to quickly educate patients and caregivers on the best course of action to take.


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