Ranitidine Recall

Ranitidine is the generic name of the commonly used over the counter heartburn medication Zantac. Though Ranitidine is considered an over the counter medication for relief of occasional heartburn, it is also sometimes prescribed for people that need to use it regularly as a maintenance medication for stomach ulcers or chronic heartburn. Ranitidine belongs to a class of medications called H2RAs, which work by reducing the amount of acid released into the stomach and therefore decreasing the symptoms related to over-production of stomach acid such as pain from ulcers and heartburn. Ranitidine has been around since the early 1980s and is one of the most common over the counter medication requested today. H2RAs are also one of the two major prescription options for the reduction of stomach acid, the other being proton pump inhibitors. Ranitidine itself was the world’s top prescription drug by 1987, but has been largely replaced since by the newer and more effective proton pump inhibitors.

For nearly 40 years of production, Ranitidine has been manufactured regularly. Initially, it was made by  Glaxo Smith Kline, until it came off patent in the late 1990s. Since then, it has been sold in Canada by virtually every generic drug company at some point in time, with the most notable being Apotex.

September 2019 Ranitidine Recall

On September 13th, 2019, Health Canada became aware of an impurity in some generic Ranitidine tablets called N-nitrosodimethylamine (NDMA for short). NDMA is classified by Health Canada and the FDA as a probable carcinogen if consumed in quantities deemed excessive over long periods of time. NDMA is a commonly occurring chemical at extremely small concentrations in certain foods such as meats, dairy, and vegetables, as well as drinking water, but these regular levels we are all exposed to are deemed safe.

The levels of NDMA found in some Ranitidine tablets was deemed to not be safe for human consumption, and thus one generic drug company named Ranbaxy Pharmaceuticals voluntarily withdrew all Ranitidine it had on the market so that it can be tested for this impurity. Over the following days, more pharmaceutical companies followed suit, voluntarily, to test their own stocks of Ranitidine and determine whether or not they contained the NDMA impurity. It is important to note that these recalls were all initiated by the pharmaceutical companies voluntarily, rather than by Health Canada, as a precautionary measure in the interest of patient safety. These recalls do not definitively mean that the pharmaceutical companies believe there is an impurity in their products and that their patients have been exposed to those chemicals, but as these chemicals are not routinely screened for, they would have to pull the medication off the market in order to do further testing.

Unfortunately, since every manufacturer of Ranitidine pulled their entire stock off the market, there is currently an ongoing shortage of Ranitidine in Canada. When a recall is started by the manufacturer, pharmacies are asked to send their current stock back, and may be asked to inform patients on those medications depending on the severity of the cause of the recall. This leaves a lot of patients on Ranitidine prescriptions without a lot of options.

What should you do about your Ranitidine prescription?

If you used to take Ranitidine, you may be wondering what your options are given that your medication is no longer available on the market. Luckily, there are a few options outlined below.

  1. Ask your doctor or pharmacist to be switched to another medication in the same class.
  2. Ask your doctor or pharmacist to be switched to another class of medication.
  3. Choose antacids, another over the counter option for heartburn.

Alternatives to Ranitidine

  1. Other H2RAs

The first step to take when one of your medications has been recalled is to find out if there are other similar medications that you can take instead. In Ranitidine’s class there are three other medications called Famotidine (brand name Pepcid), Nizatidine (Axid), and Cimetidine (no brand name). Pepcid and Axid are available over the counter, ask your pharmacist about these options. Famotidine and Cimetidine are also available as prescription medication. You can ask your doctor about these options, or speak with your pharmacist to fax your doctor. When switching medication, be sure to talk to your healthcare professional about any other medications you may be taking in case there might be a potential unwanted side effect when both are taken together.

Due to a large portion of Ranitidine patients being switched to the less popular Famotidine, it is also in short supply. A lot of pharmacies may be having trouble in finding this medication, in which case you may be better off with finding a drug from a different class.

  1. Proton Pump Inhibitors

Proton pump inhibitors are a new generation of stomach acid inducers. This class is wide-ranging, and there are more than half a dozen options within it, all of which are effective at controlling symptoms of acid reflux. Of note, there are at least two over the counter options in Omeprazole (brand name Olex), and Esomeprazole (brand name Nexium). You can find these medications at your local pharmacy, but be sure to talk to your pharmacist about starting them, even if they are available over the counter. Similarly, you can request to receive a new prescription from your pharmacist or doctor for one of these medication, especially since they are covered by most public and private insurance, rather than paying out of pocked for them over the counter.

  1. Antacids

For those of you who used to only take a tablet of Zantac once in a while and not regularly, there are other effective options for relief of occasional heartburn. The most popular of these options are antacids, like Calcium Carbonate (brand name Tums), and are taken as chewable tablets after meals that cause heartburn. These medications have the upside that they can also double as a calcium supplement. Calcium Carbonate helps neutralize the acid in your stomach, and thus works very quickly, but has to be taken after every meal that causes heartburn, unlike the previously discussed medications. As any other medication, antacids can cause side effects, so be sure to read the label and discuss this option with your pharmacist before starting.

Reference:

Health Canada. (2019). Health Canada assessing NDMA in ranitidine. Retrieved from:
https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70989a-eng.php


If you have any questions or client issues regarding this article or its contents, feel free to reach out directly to Rx Infinity or contact us here at ASSOCIUM and we will facilitate the connection or you. If your issue or question is specific to your personal and prescribed medication, please contact your physician or your providing pharmacy.

This information is not intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health provider with any questions about your medical condition. Do not disregard professional medical advice or delay seeking advice or treatment because of something you have read here.