Oct 16 2019
Ranitidine Recall

Ranitidine Recall: What Are My Options?

October 16, 2019 4:27 pm Published by

By: Andrea Zhao, RPh

 

You may have heard that Health Canada has advised all companies to stop distributing ranitidine-containing medication as they continue to investigate for traces of N-nitrosodimethylamine (NDMA) above what is considered to be safe if the drug were to be taken over a lifetime.1 Ranitidine belongs to a family of medications called histamine-2 (H2) blockers. It works by reducing the production of excess stomach acid. NDMA is an impurity which is potentially carcinogenic if ingested at higher levels than what is considered to be safe over a long period of time. Exposure to low levels of NDMA is not considered to be carcinogenic.1

As of September 25, 2019, ranitidine drugs are being recalled by Apotex Inc., Sandoz Canada, Pro Doc Limitée, Sanis Health Inc., and Sivem Pharmaceuticals ULC.1 Lots not being recalled have not yet been found to contain NDMA above acceptable levels and continue to be available in pharmacies. To date, over-the-counter ranitidine products have not been recalled.

Health Canada, in collaboration with other international regulators, are continuing to investigate this issue.1 At the present moment, Health Canada is advising that patients do not stop taking the medication without first discussing with their physician whether it would be appropriate to discontinue therapy.1 If determined that it’s more beneficial for treatment to be continued, alternative treatment options may be considered.

Your Pace Pharmacy team would be happy to assist you in finding the most suitable alternative for your needs. For most conditions, patients only take H2 blockers on an as-needed basis for occasional heartburn and indigestion caused by production of too much stomach acid.  However, possible alternatives for patients requiring ranitidine for a longer period of time include switching to an alternative H2 blocker. There are other medications in the same family! For example, we can compound cimetidine (brand name: Tagamet) or famotidine (brand name: Pepcid) capsules or suspensions. There have been no findings of NDMA in these H2 blockers to date. You should discuss with your doctor if either of these options would be suitable for you. Your Pace Pharmacy team can also fax your doctor for these alternatives. If you have any further questions or concerns, please do not hesitate to contact your Pace Pharmacy team.

If appropriate, some patients find that antacids (such as Tums, Rolaids, or Gaviscon) are helpful for relieving their heartburn.

Some other suggestions health care professionals recommend for relieving heartburn symptoms include2:

  • quitting smoking and avoiding alcohol
  • avoiding certain foods (i.e. large fatty meals, chocolate, caffeine, spicy foods)
  • wearing looser clothing
  • not eating on the run or within two hours of bedtime
  • not lying down right after eating
  • avoiding certain medications if known to worsen your heartburn (i.e. non-steroidal anti-inflammatories like Advil or Aleve).  Tylenol may be a better alternative – discuss this with your Pace Pharmacist or doctor.

 

Where can I go for more information?

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/71029a-eng.php#images-images

http://www1.apotex.com/docs/librariesprovider5/safety-advisories/ranitidine-public-advisory-english-(ca-market-only).pdf?sfvrsn=ed2c12d6_0

 

References:

  1. Health Canada. (26 September 2019). Health Canada requests that companies stop distributing ranitidine drugs in Canada while it assesses NDMA; additional products being recalled. Retrieved from https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/71029a-eng.php
  2. CPS [Internet]. Ottawa (ON): Canadian Pharmacists Association; c2016 [updated 2018 04; cited 2019 10]. Dyspepsia and Peptic Ulcer Disease. Available from: http://www.e-cps.ca or http://www.myrxtx.ca. Also available in paper copy from the publisher.

 

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This post was written by Adam Silvertown

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