Q. I just learned that the ranitidine I was prescribed has been recalled. Can you tell me more about it and what my options are going forward?
A. Last month Health Canada urged the companies that manufacture ranitidine to stop its distribution until further notice due to an impurity that has been found in some of the products. Initially, this recall was only on some of the manufacturers of this drug but it has now been extended to all.
Ranitidine is a histamine -2 (H2) blocker that reduces the amount of acid that is being produced in the stomach. It is available both over the counter and as a prescription and is commonly used to treat and prevent heartburn, ulcers and gastro esophageal reflux disease (GERD).
The impurity found among the ranitidine products is NDMA (N-nitrosodimethylamine) which is a probable carcinogen however, this would typically be only with high doses over a long period of time. NDMA is an environmental contaminant that we may be exposed to already in our water or foods such as meat, vegetables and dairy products.
With respect to ranitidine, Health Canada maintains that the cancer risk with this NDMA exposure is low and is not suggesting that people stop taking the ranitidine they currently have on hand. However, due to this recall, pharmacies are not able to supply more ranitidine to anyone. Nor can they supply its sister drug famotidine/ Pepcid, as its stockpile was rapidly depleted by the many people who initially switched over from ranitidine.
For many people, an alternative that can be tried is another class of medications called proton pump inhibitors (PPIs) such as pantoprazole (Tecta), omeprazole (Losec) or rabeprazole (Pariet) to name a few. They are generally stronger than the H2-antagonists and are relatively safe drugs so the changeover should be easy.
When ranitidine is available once again, most should change back, as in the very long-term, H2-antagonists like ranitidine have less risk of adverse effects than their PPI counterparts. However, some people are already on a PPI and take ranitidine along with it since they are not getting the relief they were hoping for from the PPI alone.
In those cases, one option would be to look at the current dose of the PPI as it may be possible to increase the dose. It is also a good time to review how you are taking the PPI. To get the best effect from the PPI, it is crucial to take it 30 to 60 minutes before a meal. However, a recent study indicated that only 8% of the participants took their PPI this way.
Additionally, two studies, have shown that only between 54% to 68% of patients taking a PPI requested a refill at an appropriate interval. This means that many are taking these drugs on a haphazard or when needed basis. That’s absolutely fine for many with only periodic heartburn but, for those with significant issues, these drugs will work more effectively when taken on an everyday basis shortly before eating.
There are many lifestyle choices that can be made that can also reduce the amount of heartburn or indigestion you experience. Some tactics that can be tried if you have not already done so include raising the head of the bed by a couple of inches (put a piece of plywood or two under the head of the bed rather than an extra pillow which can strain your neck), losing weight, refrain or reduce your intake of alcohol, tobacco, caffeine, coffee, citrus fruits and their juice, chocolate, fatty foods and spicy foods.
If all of the above have been tried and yet there is still much discomfort, there are still some other drugs that might warrant a trial. Prokinetics such as domperidone (Motilium) are a class of medications that increase the movement or motility of food through the digestive system. One analysis of the PPI/prokinetic combination did not show an improvement of symptoms but it did seem to improve quality of life.
There are also medications that promote gastric emptying such as metoclopramide (Maxeran) but again it did not seem to show as much improvement as was hoped and more studies need to be performed.
Another medication that just might be of benefit is baclofen. A study looked at baclofen (a muscle relaxant) 20mg three times daily with the PPI and showed symptom improvement and a significant reduction of duodenogastric reflux episodes. Since baclofen acts on the central nervous system, there are some possible associated side effects that might limit its use such as dizziness, drowsiness and weakness. Taking baclofen in the evening can help overcome those side effects which may also dissipate on their own over time as your body gets used to the medication.
Several antidepressants such as citalopram, fluoxetine and trazodone have been reviewed and shown to be of benefit in reducing symptoms of heartburn and/or associated chest pain in some people as well.
There is also the drug sucralfate which works by providing a protective coating between the acid and the lining of the gastrointestinal tract and has been used for decades in the treatment of ulcers and GERD. If you are somebody that is affected by the ranitidine recall and would like more information on this or any other topic, contact your pharmacist.