FDA Warns Zantac Has Cancer Causing Chemical
Officials with the U.S. Food and Drug Administration (FDA) said they are investigating low levels of a potentially dangerous contaminant in the popular heartburn medication Zantac and related generic drugs. According to a CBS News report, FDA officials said in a public statement that they have detected a probable cancer-causing chemical in ranitidine, the generic medication sold as both prescription and over-the-counter drugs to treat stomach acid and ulcers. The federal agency said the carcinogenic ingredient is a type called nitrosamine called N-nitrosodimethylamine or NDMA.
FDA has said patients could continue taking Zantac or other similar heartburn medications for now. But officials also say that if you are using prescription versions and want to stop using them, you can consult your doctor to discuss other treatments. Zantac maker Sanofi said in a statement that it takes patient safety seriously and that they are committed to working with the FDA.
Potential Effects Being Studied
While NDMA can be extremely dangerous in large quantities, the amount found in the heartburn drugs is among the levels found in common foods, FDA officials said. That said, they say they don’t know what kind of impact this amount could have on human beings. The FDA is still looking into whether low levels of the carcinogen in these drugs is a risk to patients and has said it will post its findings as soon as possible.
NDMA is the same chemical that has been linked to a number of prescription drug recalls, especially medications to treat high blood pressure over the past year including a commonly prescribed drug called valsartan. Those recalled drugs, which were made in China, had higher levels of the NDMA chemical than U.S. health officials deemed acceptable.
Challenges with Regulation
The FDA is still looking into this issue and last month, the agency sanctioned a manufacturing plant in India that makes some of the ingredients used in the medications. The FDA is responsible for making sure that drugs manufactured and sold in the United States are safe and are manufactured under sanitary conditions.
But drug regulators have struggled for years to inspect the supply chain as pharmaceutical production is now done worldwide, especially in China and India. According to the Government Accountability Office (GAO), about 80 percent of ingredients that are used in U.S. drugs today are manufactured abroad, particularly in those two countries.
If you or a loved one has suffered adverse health effects as a result of these types of contaminated, dangerous or defective drugs, you may be able to file a product liability lawsuit against the drug manufacturer and other parties involved. An experienced product defect attorney will be able to help you better understand your legal rights and options.