In September, the Food and Drug Administration (FDA) announced that it had detected low levels of an impurity that could cause cancer in products containing ranitidine. These products include the popular heartburn drug Zantac and its generic versions. While the FDA had not issued a recall on these drugs, retailers such as CVS, Walgreens, and Walmart have pulled the products from their shelves while the FDA continued its review of the product. In October, drug makers issued a recall for prescription-strength Zantac. Over the counter Zantac products were not affected by the recall. The manufacturers of some generic products have also instituted their own recalls.
Cancer Risk
During studies of the heartburn drugs, the FDA found low levels of a nitrosamine impurity known as N-nitrosdimethylamine, or NDMA. Based on laboratory tests, NDMA has been classified as a human carcinogen, meaning that it may cause cancer in humans. NDMA is an environmental contaminant that can be found in water and foods, including meat, vegetables, and dairy products. Studies show that ranitidine, the active ingredient in some heartburn drugs, may convert into NDMA in the body. A small study found that individuals who took Zantac had NDMA levels in their urine that were 400 times greater than what the FDA considers acceptable.
Other Drugs Under Investigation
Over the past year, the FDA has been investigating the presence of NDMA in other drugs as well. Levels of NDMA were found in blood pressure medications containing valsartan, losartan, or irbersartan. The FDA recalled some of these medications in light of the cancer risk. In addition, the FDA has been investigating heart medications that are angiotensin II receptor blockers or ARBs. These medications block a potential chemical in the blood that causes the muscles surrounding blood tissue to contract. It is believed that these drugs that are used to treat heart failure may contain levels of the impurity, as well.
Contact an Experienced Product Liability Attorney
If you’ve been injured by a dangerous drug, you may want an experienced product liability attorney on your side. At Bonina & Bonina, P.C., we have over 50 years of experience helping New Yorkers injured by defective products. Contact us online or call us at 1-888-MEDLAW1 to schedule your free consultation. Home and hospital visits are available. Se habla español.