FDA Finalizes Guidelines To Keep Cancerous Impurities Out of U.S. Medications

Nitrosamine contamination has resulted in massive recalls for valsartan, Zantac and other medications, as well as lawsuits by users who developed cancer.

Following years of problems with nitrosamine contamination in widely used drugs, which has resulted in high profile Zantac recalls and valsartan recalls that impacted millions of consumers, federal regulators have finalized new guidelines aimed at keeping the toxic chemical impurities out of medications in the U.S.

Concerns about side effects of nitrosamine impurities gained widespread attention in 2018, when a series of generic valsartan recalls were issued, after certain versions of the hypertension drug were found to contain unsafe levels of the chemical byproduct nitrosodimethylamine (NDMA), which is a potential human carcinogen.

These nitrosamine impurities were found to be the result of changes to the generic drug manufacturing process, leading regulators and drug manufacturers to start looking for the contaminant in other medications. As a result, recalls have been issued for a wide variety of medications in recent years, including Chantix, Metformin and Zantac.

Tens of thousands of consumers exposed to drugs with nitrosamine contamination are now pursuing valsartan lawsuits and Zantac lawsuits, alleging they developed various forms of cancer after using the medications.

In response to concerns about the health risks consumers may face from the contamination, the U.S. Food and Drug Administration (FDA) issued finalized guidelines for controlling nitrosamine impurities in human drugs on August 30.

The guidance recommends limits for certain nitrosamine impurities, determined by how much they could increase the risk of cancer, as well as recommended implementation guidelines and testing techniques.

“This guidance recommends steps manufacturers of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products,” FDA officials said in a press release. “The guidance discusses the potential root causes of the presence of nitrosamine impurities, detection of nitrosamine impurities, and recommendations for risk assessments, testing, and implementation of controls and other appropriate strategies to prevent or reduce the presence of nitrosamine impurities in APIs and drug products.”

This latest guidance comes about a year after the FDA issued guidelines for acceptable limits of nitrosamine in drugs, which provided a framework for predicting the possible presence and likelihood of nitrosamine contamination.

The agency notes that it will work with manufacturers to try to keep certain key drugs on the market, particularly if issuing a recall would lead to a shortage. This may include interim acceptable limits that are more lenient than usual.

September 2024 Valsartan Lawsuit Update

The makers of valsartan, whose recall sparked nitrosamine contamination concerns in the U.S., face about 1,200 valsartan lawsuits filed in federal courts nationwide, which have been consolidated for coordinated pretrial proceedings before U.S. District Judge Renee Bumb in the District of New Jersey as part of a valsartan MDL, or multidistrict litigation.

In June, the parties announced a valsartan settlement agreement had been reached to resolve all claims involving one of the generic manufacturers involved in the litigation, Hetero Labs, resolving personal injury, economic loss and medical monitoring claims.

Details on the proposed settlement have not been released, but lawyers indicate the only Hetero valsartan lawsuits that would remain unresolved are those associated with economic loss lawsuits linked to losartan, a similar hypertension drug from the same class of medications. Hetero is the only manufacturer involved in the settlement agreement, which has not yet been finalized.

Plaintiffs also indicated that they are preparing a motion calling for the preliminary approval of a valsartan class action settlement agreement. However, the most recent status report indicates that negotiations to settle other valsartan lawsuits have stalled, though defendants say they believe progress is being made.

Even if the Hetero valsartan settlement agreement is finalized, it would still leave hundreds of lawsuits pending against other manufacturers, which will likely face future bellwether trials to help the parties gauge the average payout juries may award for individuals diagnosed with various forms of cancer. However, if those drug makers fail to settle the remaining valsartan claims or otherwise resolve the litigation, hundreds of individual cases may later be remanded back to different U.S. District Courts nationwide for separate trial dates in the future.