Nitrosamine Contamination Claims Continue to Mount for Big Pharma

Recent discoveries of a cancer-causing chemical in prescription and over-the-counter medications may cost billions of dollars for several large pharmaceutical companies. Nitrosamine, a chemical contaminant has resulted in major drug recalls for drugs manufactured by pharmaceutical giants including GlaxoSmithKline, Pfizer, Sanofi, Merck and Boehringer Ingelheim.

Most recently, Merck’s blockbuster antidiabetic medication, Januvia, and sister medication, Janumet have been found to be contaminated with Nitrosamines. Though many medications have been recalled or discontinued, the Food and Drug Administration (FDA) has currently relaxed the limit for nitrosamine in Januvia. The Agency is currently allowing Merck to continue selling the medication on the grounds that benefits still outweigh the risks and a shortage of medication may be catastrophic for some diabetic patients.

Consumer advocate group Public Citizen has noted that the potential for injury caused by nitrosamine contamination is even more troubling because of the number of drugs already involved and the number keeps rising. Lawsuit filings and settlement amounts may also continue to rise as each drug recall brings attention to the entire issue of nitrosamine contamination

Nitrosamine Becomes a Health Concern in Pharmaceuticals

Nitrosamines are a group of organic compounds which are known to cause cancer and other health risks. Though they have long been known to cause cancer, they haven’t been a large concern in pharmaceuticals. Unlike most drug recalls which are conducted for obvious contamination with visible defects, or drugs that are recalled for emerging health risks, chemical contamination may be more difficult to detect.

In 2018 however, testing of active ingredients for a generic form of the high blood pressure medication Diovan, proved to contain NMDA. The active ingredient valsartan was the first of a string of contaminated medications that was identified, in part because manufacturers began looking for the chemical.

The FDA then instructed all drug manufacturers to begin testing for NDMA and other nitrosamines. Since that time, it has been found in 250 or more prescription and generic products.

Drugs affected by nitrosamine contamination have not all been recalled, depending in part, on how critical the medication may be and what alternatives may be available. Recalls have sometimes resulted in medications being unavailable for use temporarily or in some cases, permanently.

Medications affected by nitrosamines have included:

• Chantix
• Variniclene
• Metformin
• Valsartan
• Losartan
• Irbesartan
• Zantac
• Ranitidine
• Axid
• Nizatidine
• Rifampin
• Rifapentine
• Januvia
• Janumet
• Sitagliptin
• Accupril
• Accuretic

Not all of the affected medications have been recalled and testing is still ongoing. Other medications may also be involved as the problem continues to emerge, including outside of the U.S.

GlaxoSmithKline, makers of the anti-ulcer medication Zantac which became available as an over-the-counter medication recalled all of its medication forms and other generic forms of ranitidine were also discontinued. Another ulcer medication, Axid and generic forms of nizatidine were discontinued shortly after. Zantac trials for nitrosamine contamination are scheduled to begin in February 2023 in California. Some industry experts suggest that the big companies may face tens of thousands of lawsuits not-yet-filed, in addition to those already gathering in federal, state, and local courts. Companies may face upwards of $45 billion in settlements for current and future lawsuits filed over nitrosamine contamination.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.