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CVS recently took Zantac and other ranitidine medication off their shelves due to concerns that the drugs are contaminated with a carcinogen.
On Sept. 28, CVS Pharmacy announced that they had stopped the sale of Zantac brand and CVS Health brand ranitidine products.
According to the pharmacy, these ranitidine medications may be contaminated with a low level of a probable human carcinogen.
Zantac and generic ranitidine are H2 blockers used to treat high levels of stomach acid which can aggravate conditions such as peptic ulcers, gastroesophageal reflux disease (GERD), and other diseases.
Earlier in September, the U.S. Food and Drug Administration (FDA) released a safety announcement alerting the public that some ranitidine medications may be contaminated with low levels of N-nitrosodimethylamine (NDMA).
NDMA is an environmental contaminant which may be found in water, meats, dairy products, and vegetables. Although the chemical occurs in these sources at low levels, NDMA may also be generated as a waste from certain industrial processes. Unfortunately, NDMA is a probable human carcinogen – meaning that it is suspected to cause cancer in humans based on laboratory tests.
According to the FDA, low levels of NDMA were found in some ranitidine medications. The agency says that the affected drugs are not being recalled and individuals don’t necessarily need to stop taking Zantac or other ranitidine medications at this time. However, the FDA notes that patients can talk to their doctor about other treatment options if they are concerned about exposure to the carcinogen.
Although the risk of NDMA contamination in Zantac is still being evaluated by the FDA, CVS reportedly decided to suspend the sale of ranitidine products “out of an abundance of caution” following the FDA alert.
“Consumers seeking alternate therapy to treat their condition should speak with their healthcare provider or a CVS pharmacist,” CVS notes in their announcement. “CVS pharmacists are always available to discuss any questions or concerns that customers may have about their medications.”
Some ranitidine manufacturers have announced similar plans to halt sales while the risk of NDMA contamination is being evaluated. Sandoz, a division of Novartis, has voluntary recalled all of their generic ranitidine capsules although they have not received any adverse event reports.
Although some companies are taking a proactive stance, Zantac manufacturer Sanofi says that “there are currently no plans to stop distributing or manufacturing Zantac.”
The manufacturer released a statement, according to CBS, justifying their decision by noting that the amount of NDMA found in Zantac barely exceeds the amount found in common foods.
In a statement made to The New York Times, Sanofi said “We are working closely with the F.D.A. and are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards.”
This is not the first time that NDMA has been named as a medication contaminant. In 2018, countless batches of angiotensin receptor blockers (ARBs) were recalled due to “unacceptable levels” of NDMA and other contaminates. This included the recall of certain batches of ARBs such as valsartan, losartan, and other medications.
A study published in the journal BMJ reportedly found no “markedly increased short term overall risk of cancer” in patients taking contaminated valsartan, but researchers noted that further investigation into the long term risks is needed.
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