10 prominent drugs recalled over nitrosamines

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In recent years, a number of drug companies have carried out prominent recalls of hypertension, heartburn and diabetes medications due to the presence of nitrosamines, organic compounds shown to cause cancer in animal studies.

The problem could cost Big Pharma companies billions of dollars, but proving the cancer-causing role of nitrosamines in drugs may be difficult. (Note: Nitrosamines are also in a host of processed foods, including cured meats.)

Morgan Stanley had estimated that the presence of nitrosamines in Zantac, once the best-selling drug in history, could cost GSK, Sanofi and Pfizer between $10.5 billion to $45 billion in trial judgments. But U.S. District Judge Robin Rosenberg dismissed claims related to the matter, questioning plaintiffs’ reasoning in interpreting the data linking nitrosamines in Zantac with cancer.


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Expert interview: Are nitrosamine formation inhibitors the key to successful mitigation plans?

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The presence of toxic nitrosamine impurities in drug substances and drug products has become a significant focus for the pharmaceutical industry following their identification above permitted limits in common drug products prescribed for type 2 diabetes, high blood pressure and heartburn. To learn more about the situation, we interviewed David Elder – CMC consultant – who explained what we know about nitrosamine impurities, how they form, and the steps formulators can take to minimize the risk of formation in existing drug products and future developments.

Elder has 45 years of service within the pharmaceutical industry, with Sterling, Syntex and 23 years with GSK. He is now an independent CMC consultant and has broad based experience in impurity control, formulation (including stabilization strategies) and analytical method development.

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Pfizer recalls certain lots of blood-pressure drug Accupril

Pfizer (NYSE:PFE) has announced a voluntary recall of five lots of Accupril (Quinapril HCl) tablets owing to elevated levels of the nitrosamine N-nitroso-quinapril. 

Accupril, an angiotensin-converting enzyme (ACE) inhibitor, is indicated for treating hypertension. FDA has also approved its use as an adjunctive therapy for treating heart failure. 

N-nitroso-quinapril, which can be frequently found in water and some foods in low levels, may pose a cancer risk in higher levels. 

Pfizer concluded that the nitrosamine in certain Accupril lots was above the acceptable daily intake value.  

The company has not observed adverse event reports related to the elevated levels of N-nitroso-quinapril in some lots. 

Pfizer reports that the affected lots were distributed in the U.S. and Puerto Rico from December 2019 to April 2022.

In recent years, FDA has exerted pressure on the pharmaceutical industry to test potentially hundreds of medications f…

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