Beware! This commonly used medicine increases the risk of fractures and diarrhea!

Expert of this article: Pan Kunming, Master of Pharmacy from Peking University, Chief Pharmacist of Zhongshan Hospital Affiliated to Fudan University

When you buy or take medicine, do you have the habit of reading the drug instructions carefully? The drug ingredients, dosage, adverse reactions, and precautions in the instructions are actually very important! With more research and evaluation, these contents have been constantly updated.

Recently, the State Food and Drug Administration issued an announcement on the revision of the instructions for use of proton pump inhibitors:

Screenshot of the National Drug Administration’s official website

According to the results of adverse drug reaction assessments, in order to further ensure the safety of public drug use, the State Drug Administration has decided to uniformly revise the instructions for proton pump inhibitors (including omeprazole oral preparations, omeprazole injection, esomeprazole sodium for injection, pantoprazole oral preparations, pantoprazole injection, lansoprazole oral preparations and injections, rabeprazole oral preparations, rabeprazole sodium for injection, ilaprazole enteric-coated tablets, and ilaprazole sodium for injection).

Instructions revision requirements

Adverse reactions and precautions include the following, and are described in detail:

Hip, wrist, or spine fractures

Clostridium difficile-associated diarrhea

Hypomagnesemia

Proton pump inhibitors are also the most commonly used "stomach medicine". By inhibiting gastric acid secretion, they are widely used to treat acute and chronic acid-related diseases of the digestive system, including gastric ulcer, duodenal ulcer, gastroesophageal reflux disease, gastrinoma, upper gastrointestinal bleeding, eradication of Helicobacter pylori infection, and stress-induced gastric mucosal lesions, etc., due to their rapid onset, strong and lasting effects, safety, and good tolerance. It is one of the most widely used drugs in hospitals.

The characteristic feature of the names of this type of drugs is that they all contain the word "prazole". There are currently 6 types of drugs on the market in my country, all of which are included in the requirements for the revision of the instructions this time.

Screenshot of the National Drug Administration’s official website

In fact, the State Food and Drug Administration issued a safety warning in 2015, and this time it put forward clear revision requirements.

Increased risk of fractures, especially in older adults

Studies have shown that prazoles may increase the risk of fractures due to osteoporosis of the hip, wrist, or spine. The risk of fractures is increased in patients who receive high doses (multiple doses per day) and long-term treatment (a year or more).

Prazosins may increase the overall risk of fractures by 10%-40%. Patients at risk of osteoporosis should be treated according to current clinical guidelines and physician recommendations and should take adequate amounts of vitamin D and calcium.

Increased risk of diarrhea caused by Clostridium difficile infection

The use of prazoles for treatment may slightly increase the risk of gastrointestinal infections caused by bacteria, such as Salmonella, Campylobacter, and Clostridium difficile infections; in hospitalized patients, Clostridium difficile infections are of particular concern. If diarrhea does not improve, it may be related to prazoles and should be discontinued promptly.

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Rare hypomagnesemia

Rare cases of asymptomatic or hypomagnesemia have been reported in patients treated with prazoles for more than 3 months, and particularly in patients treated for more than 1 year.

Severe hypomagnesemia may manifest as fatigue, rigidity, tetany, convulsions, dizziness, confusion, epileptic seizures, twitching, dizziness, and arrhythmia, but the above symptoms are often not obvious at the beginning and are easily overlooked.

Hypomagnesemia improved in most patients after magnesium supplementation and discontinuation of prazoles.

For patients who require long-term treatment or who are taking digoxin or other drugs that may cause hypomagnesemia (e.g., diuretics), blood magnesium levels should be monitored regularly during medication.

What other adverse reactions should I watch out for?

Causes acute interstitial nephritis: Usually due to idiopathic hypersensitivity reaction, the drug must be discontinued immediately if it occurs.

Causes vitamin B12 deficiency: Long-term (e.g., more than 3 years) daily use may cause vitamin B12 deficiency.

Skin and systemic lupus erythematosus: Most patients have mild symptoms, only rash. Once found, seek medical attention immediately. Most patients will improve within 1-3 months after stopping the drug.

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The prazole class of drugs are generally effective and safe, but the following points should be noted when taking them:

To achieve maximum efficacy, prazole drugs should be taken 30-60 minutes before breakfast.

Enteric-coated tablets (capsules) need to be swallowed whole and should not be chewed or crushed to avoid premature release in the stomach and affecting efficacy.

With so many adverse reactions, can we still take the medicine normally?

First of all, there is no need to worry too much. The newly added adverse reactions are related to long-term medication (more than one year) and generally do not occur with short-term medication. Moreover, they are relatively mild in the early stages and can mostly be relieved by stopping the medication in time.

For people who take medication for a long time, pay attention to regular monitoring of the corresponding indicators, and stop taking the medication in time if any problems are found. For example, for the risk of fractures, high-risk groups can monitor bone density every six months or take calcium supplements in advance according to their specific circumstances.

In conclusion

Adverse reactions often concerned

Maintain proper vigilance

Early prevention, timely intervention

Avoid more serious problems

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