The December AEMPS report updated the list of unwanted reactions for omeprazole. Which patients will have to be more careful?
The Spanish Agency for Medicines and Health Products or AEMPS announced a new side effect of omeprazole, one of the most widely consumed drugs worldwide. It should also be noted that, beyond mass consumption, there is a tendency for the population to take it for many months. According to some surveys, the average time of consumption among patients is 2 years, at a rate of 20 mg per day.
Like any drug, omeprazole is not exempt from side reactions. Some are better known and expected than others, but over the years and their presence in pharmacies, it is possible to discover new unwanted effects.
In its Monthly security bulletin December 2022, the AEMPS reported that tubulointerstitial nephritis is a newly recognized side effect of omeprazole. The problem is that this condition can evolve into kidney failure.
What is omeprazole used for?
Omeprazole is a stomach proton pump inhibitor. Therefore, its action is to reduce the production of hydrochloric acid inside the digestive system.
By inhibiting this pump, the pH rises and the environment becomes less acidic. It is not the same as other medications considered antacids, which are responsible for blocking the acidity already produced. In this case, the active principle reduces production from the start.
For this reason, omeprazole is considered to be very effective in treating gastritis, peptic ulcer, some functional dyspepsia and even infection by Helicobacter pylori. In itself it is very safe, but the prescription should not exceed 8 weeks. For two months it is possible to ensure certain safety; then there are some consequences that are associated with continued and unsupervised employment.
As we already anticipated, the population trend is towards excessive consumption, reaching up to 2 years of daily intake. Therefore, many of the unwanted reactions can arise from abuse and not for the use approved and endorsed by scientific guidelines.
Common Adverse Effects of Omeprazole
The legal package inserts of the trademarks that manufacture omeprazole mention the following as frequent unwanted reactions:
- Headache or headache.
- Diarrhea or constipation.
- Nausea and vomiting.
- Flatulence.
All these symptoms are to be expected and, although they do not always appear, its presence is recognized by research on omeprazole. Before them, it is best to consult with the doctor who prescribed the active ingredient, to assess alternatives.
Side effects from chronic use of the drug
The adverse effects that could appear due to the abuse of omeprazole have also been investigated. Here we include the excessive use that a large part of the population practices, through self-medication.
A 2016 report mentioned that the following are reactions attributable to chronic employment:
- Reduced effectiveness of anticoagulant and antiplatelet drugs. Therefore, it would increase the cardiovascular risk.
- Increased risk of pneumonia. With less stomach acid, bacteria are faced with a weakened barrier that allows them to reproduce easily.
- Hypovitaminosis. Above all, a deficiency of vitamin B12 is seen in chronic users who are elderly or have diabetes diabetes concomitantly.
- Hypomagnesemia. Circulating magnesium concentration is reduced in patients taking the drug for more than 1 year.
Adverse effects not reported in the package inserts
Finally, a 2018 review found some adverse effects of the drug that are not listed in most package inserts, but that researchers attributed to the active ingredient:
- Heart failure.
- Myocardial infarction.
- Shaking chills.
- Dementia.
What is the new side effect of omeprazole recognized by the AEMPS about?
The AEMPS reported that tubulointerstitial nephritis is a side effect of omeprazole that we must consider. Therefore, precautions are increased by having to prescribe this drug to patients who already have a history of kidney disease.
This nephritis is an inflammation that occurs in the part of the kidney tissue that is located between the tubules, that is, between the units responsible for forming urine. Those who suffer from it may have an increase in the amount of urine, desire to urinate at night, lower back pain and loss of blood in the urine.
Although there are other causes that can generate it, in recent times it has been found that 70% of cases are secondary to a medication. Non-steroidal anti-inflammatory drugs are the main culpritsas well as some antibiotics (beta-lactams and ciprofloxacin).
Regarding omeprazole and its possibility of generating tubulointerstitial nephritis, it is expected that about 20 users of the drug for every 100,000 suffer from it. Some have the injury with just 15 days of use, while in others it can take 18 months until it manifests itself.
How should I take the medicine to avoid this effect?
What should always be clear is that we should not self-medicate. Use without medical supervision exacerbates the chances of adverse effects.
Therefore, although in our country there is free sale, it is preferable to have a prescription. Furthermore, the treatment plan should be limited to what is recommended by scientific guidelines. And that, in most cases, it is restricted to no more than 8 weeks.
Some adverse effects are unavoidable. However, taking the precautions of scientifically proven use, the risk is reduced.
You might be interested…