Popular heartburn drug ranitidine recalled: What you need to know?

Joshua Gagne, PharmD, ScD
If you or a loved one take ranitidine (Zantac) to alleviate heartburn, you’ll have heard that the FDA has found a probable human carcinogen (a substance that would cause cancer) in it. The story is unfolding quickly and lots of details remain murky. Here is what we all know thus far and what you ought to do. ranitidine heartburn.

What do we know so far?

On September 13, 2019, the FDA announced that preliminary tests found low levels of N-nitrosodimethylamine (NDMA) in ranitidine, a heartburn medication employed by many Americans. This week, the drug companies Novartis (through its generic division, Sandoz) and Apotex announced that they were recalling all of their generic ranitidine products sold within the US. ranitidine heartburn

These announcements came after a Connecticut-based online pharmacy informed the FDA that it had detected NDMA in multiple ranitidine products under certain test conditions.

Update, October 1, 2019: Major drugstore chains including CVS and Walgreens are pulling Zantac and other generic versions of the heartburn drug ranitidine from their shelves. you’ll get FDA updates here.

What is ranitidine and which products are affected?

Ranitidine (also known by its name, Zantac, which is sold by the pharmaceutical company Sanofi) is out there both over the counter (OTC) and by prescription. It belongs to the category of medicine referred to as H2 (or histamine-2, ranitidine heartburn) blockers. OTC ranitidine is usually wont to relieve and stop heartburn. Prescription strengths also are wont to treat and stop more serious ulcers within the stomach and intestines. Multiple companies sell generic versions of both the OTC and prescription products.

So far, only Novartis/Sandoz and Apotex have recalled products. Ranitidine distributed by other companies remains on store shelves.

Health Canada, a federal office within the Canadian government, has asked all companies to prevent distributing ranitidine drugs there, indicating that “current evidence suggests that NDMA could also be present in ranitidine, no matter the manufacturer.” France has taken the step of recalling all ranitidine products. ranitidine heartburn.

What is NDMA and what harm it can cause?

NDMA is an environmental contaminant that’s found in water and foods, including dairy products, vegetables, and grilled meats. Its classification as a probable carcinogen is predicated on studies in animals; studies in humans are very limited.

It is important to understand that the NDMA in ranitidine products doesn’t pose any immediate health risks. Neither the FDA nor Novartis/Sandoz or Apotex have received any reports of adverse events associated with NDMA found in ranitidine. Although classified as a probable carcinogen, ranitidine heartburn, NDMA may cause cancer only after exposure to high doses over an extended period of time. NDMA is one among equivalent impurities that were found in certain heart medications beginning last year which resulted in the recall of the many products.

What should I do if I take ranitidine?

As the FDA and other agencies around the world still investigate ranitidine, more details will become available. In the meantime, the FDA isn’t calling for people to prevent taking the medication.

However, for several conditions, ranitidine is merely recommended for short-term use. If you’ve got been using ranitidine for a short time, now would be an honest time to debate together with your physician whether you continue to need it, and whether you would possibly enjoy alternative treatment options, including other drug classes or a special H2 blocker. supported what’s known thus farthere’s no evidence that other H2 blockers or other heartburn medications are suffering from NDMA impurities. ranitidine heartburn.

Some people might find antacids useful for relieving heartburn. Lifestyle changes, including avoiding certain foods and beverages, like spicy foods, large or fatty meals, and alcohol, also can help prevent episodes of heartburn.

Follow me on Twitter @JoshuaJGagne

Listen to Harvard experts discuss the Zantac recall during a special edition of the Living Better, Living Longer podcast.

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