Product News and Recalls

NDMA Contamination Found in Additional Blood Pressure and Diabetes Medications

additional NDMA contamination found in blood pressure and diabetes drugsPlaintiffs in valsartan-based drug lawsuits filed over possible carcinogenic contamination may have to make room for additional consumers as lawyers push for the inclusion of two other blood pressure medications, losartan and irbesartan. Batches of the drugs, in addition to valsartan, have been found to be tainted with NDMA, or nitrosodimethylamine. NDMA is a known human carcinogen and has been linked to the development of certain types of cancer.

Batches of losartan and irbesartan had already tested positive for NDMA and been recalled by the FDA. However, to date, most of the lawsuits over NDMA contamination have focused on valsartan-based medications. And, while lawyers want to consolidate NDMA contamination lawsuits around all three medications, drug makers argue that such an inclusion could vastly expand the scope of the initial lawsuit. All three medications, however, belong to the same class of drugs known as angiotensin II receptor blockers.

The diabetes drug metformin is also being investigated and tested on suspicion of being contaminated with the same carcinogen. Samples in Singapore tested positive for NDMA which prompted European Union authorities to start testing samples of the drug in their countries. The US FDA is also testing a variety of metformin-based products and has said that it will recommend recalls under the appropriate circumstances.

Authorities caution against an overreaction to news of the contamination and have stated that, while elevated, the levels discovered thus far have been comparable with background levels found in food and water. The agency has set a daily intake limit of 96 nanograms of the compound to remain within safe limits.

Recall of the drugs over low-level contamination has some experts worried. Metformin-based medications are a generally affordable and established diabetes treatment – enough so to be covered by most insurance programs. Pulling them from shelves before truly dangerous levels of NDMA have actually been discovered could lead to a lack of access to effective and affordable diabetes medications for a lot of consumers.