Last month, we discussed the California class-action lawsuit against drug manufacturers Sanofi-Aventis and Boehringer Ingelheim Pharmaceuticals. These companies produce the popular heartburn medication Zantac. Plaintiffs in the northern district of California claimed that the drug contains unacceptable levels of a drug called N-nitrosodimethylamine (NDMA) when taken as instructed for long-term conditions such as peptic ulcer disease. On Sept. 13, the FDA announced some ranitidine medicines, including those sold under the brand Zantac, contained “low levels” of the NDMA impurity.
NDMA is classified as a semivolatile organic chemical by the EPA. It is a compound that forms in both industrial and natural processes. It is classified as a B2 carcinogen (probable human carcinogen). Potential symptoms of overexposure to NDMA include headache; fever; nausea; jaundice; vomiting; abdominal cramps; enlarged liver; reduced functioning of the liver, kidney, and lungs; and dizziness. The chemical compound is listed as a “priority toxic pollutant” in the Code of Federal Regulations. NDMA has been found in ranitidine, a component of Zantac and related medications.
The FDA has not recommended that patients stop taking ranitidine containing ranitidine but have stated that they are investigating claims related to these drugs.
While the recommended dosage for occasional heartburn is below the recommended daily level of NDMA, the recommended dosage for long-term issues, such as peptic ulcers, does exceed that threshold.
Now drug stores and major retailers are pulling Zantac and related drugs off the shelves due to the potential cancer link. Last weekend, major retailers including CVS, Wal-Mart, and Walgreens announced that they would suspend sales of Zantac as well as generic versions.
Today, GlaxoSmithKline (GSK) has announced that it is recalling a prescription-only version of Zantac in the United Kingdom. The over-the-counter version of the drug is manufactured by a different company and has not, at the time of this writing, been recalled.
There has been criticism over the reaction in the United States. The FDA is not putting any pressure on drugmakers to take any action but is “recommending” that drugmakers follow its lead and use a low-heat method of testing the antacids and not the high-temperature method used by a “third-party laboratory,” which it says actually generates NDMA and so displays much greater levels of the impurity. Additionally, it also has requested that drugmakers send samples to the agency for testing.
The actions taken by the FDA have been compared to the actions taken by different countries. In addition to the UK, Health Canada has asked all companies to stop distributing ranitidine drugs there, indicating that “current evidence suggests that NDMA may be present in ranitidine, regardless of the manufacturer.” France has also recalled all ranitidine products.
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