Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
Note: The U.S. Food and Drug Administration (FDA) today announced it is asking manufacturers of the stomach acid-reducing drug ranitidine (sold under the brand name Zantac) to withdraw their products from the market. The agency took this action because of evidence that ranitidine products break down over time, becoming tainted with increasing amounts of the probable human carcinogen N-nitrosodimethylamine (NDMA). This may result in consumer exposure to unacceptable levels of this chemical. This action comes more than six months after the FDA alerted the public that ranitidine medications were found to contain NDMA.
The U.S. public deserves better.
Although Public Citizen welcomes this long-overdue action, the FDA’s lengthy delay in seeking the removal of ranitidine products from the market is another glaring example of agency foot-dragging in response to a serious safety concern about a medical product.
Ranitidine is not a lifesaving medication and numerous other alternative prescription and over-the-counter medications effectively reduce stomach acid.
Regulators in Canada acted with appropriate haste to protect public health when their federal health agency last September announced that at its request, companies marketing ranitidine products in the country had stopped further distribution of these medications.
The FDA should have followed Canada’s lead months ago.