Vimovo belongs to the group of non-steroidal drugs and contains an inhibitor and substances that relieve inflammation. Available in tablet form. All substances are delivered to damaged cells sequentially due to the content of Esomeprazole magnesium (in the shell) and Naproxen (in the core). Naproxen reduces fever and pain. Vimovo is prescribed for the treatment of diseases of the musculoskeletal system.
Vimovo, description of the drug
Vimovo is taken orally
The drug Vimovo is taken orally. Typically, your doctor will prescribe a dosage of one tablet up to three times a day. The medication should be taken 30 minutes before meals. It is recommended to swallow the tablet whole.
It is not advisable to split or chew it, as this reduces the effectiveness of the effect.
Older patients may experience a number of side effects and complications. In other cases, side effects are less pronounced. The drug is taken to get rid of diseases such as osteoarthritis, rheumatoid arthritis, and spondylitis. The medicine should be stored at temperatures up to +30 degrees.
Vimovo
Do you know that:
The human stomach copes well with foreign objects without medical intervention. It is known that gastric juice can even dissolve coins.
The rarest disease is Kuru disease. Only members of the For tribe in New Guinea suffer from it. The patient dies of laughter. The disease is believed to be caused by eating human brains.
Scientists from Oxford University conducted a series of studies in which they came to the conclusion that vegetarianism can be harmful to the human brain, as it leads to a decrease in its mass. Therefore, scientists recommend not completely excluding fish and meat from your diet.
When lovers kiss, each of them loses 6.4 calories per minute, but at the same time they exchange almost 300 types of different bacteria.
Even if a person's heart does not beat, he can still live for a long period of time, as the Norwegian fisherman Jan Revsdal demonstrated to us. His “engine” stopped for 4 hours after a fisherman got lost and fell asleep in the snow.
Tooth decay is the most common infectious disease in the world, which even the flu cannot compete with.
Dentists appeared relatively recently. Back in the 19th century, pulling out diseased teeth was the responsibility of an ordinary hairdresser.
Millions of bacteria are born, live and die in our intestines. They can only be seen under high magnification, but if they were put together, they would fit in a regular coffee cup.
American scientists conducted experiments on mice and came to the conclusion that watermelon juice prevents the development of vascular atherosclerosis. One group of mice drank plain water, and the second group drank watermelon juice. As a result, the vessels of the second group were free of cholesterol plaques.
The highest body temperature was recorded in Willie Jones (USA), who was admitted to the hospital with a temperature of 46.5°C.
You are more likely to break your neck if you fall off a donkey than if you fall off a horse. Just don't try to refute this statement.
Each person has not only unique fingerprints, but also tongue prints.
Research shows that women who drink several glasses of beer or wine per week have an increased risk of developing breast cancer.
In the UK there is a law according to which a surgeon can refuse to perform an operation on a patient if he smokes or is overweight. A person must give up bad habits, and then, perhaps, he will not need surgical intervention.
Most women are able to derive more pleasure from contemplating their beautiful body in the mirror than from sex. So, women, strive to be slim.
Side effects and contraindications
The main side effects when using the drug include:
- Increased activity of enzymes produced by the liver. Cardiovascular disorders - arrhythmia, rapid heartbeat, insufficient blood supply to the heart, heart attacks, tachycardia, low blood pressure, shortness of breath.
- General weakness of the body, manifested in dizziness, headache, malaise, asthenia.
- Insomnia.
- Poor kidney function.
- Memory and thinking disorders, confusion.
- Nervous system disorder.
- Problems in the intestinal tract - constipation, diarrhea, belching, nausea, flatulence.
- Allergic reactions - redness of the skin, itching, rash.
Also, the drug must be taken taking into account contraindications:
- Allergies, bronchial asthma, urticaria.
- Past diseases and surgeries on the kidneys, heart, liver.
- Pregnancy, breastfeeding period.
- Presence of gastrointestinal disorders.
- Excessive sensitivity to the substances of the drug.
Lenvima, 4 mg, capsules, 30 pcs.
The safety profile of lenvatinib is based on a pooled analysis of safety data from 1,108 patients treated with lenvatinib in clinical trials, including 452 patients with differentiated thyroid cancer refractory to radioactive iodine and 656 patients with other cancers.
The most common adverse reactions in patients with differentiated thyroid cancer refractory to radioiodine (≥30% of cases) included hypertension, diarrhea, decreased appetite, weight loss, fatigue, nausea, proteinuria, stomatitis, vomiting, dysphonia, headache pain and palmoplantar erythrodysesthesia (PPE) syndrome. Most grade 3 or 4 adverse reactions occurred during the first 6 months of treatment, with the exception of diarrhea, which occurred throughout the treatment period, and weight loss, which increased over time.
Among 452 patients with differentiated thyroid cancer refractory to radioactive iodine, adverse events led to lenvatinib dose reduction in 63.1% of cases and complete drug discontinuation in 19.5% of cases. The most common adverse reactions that caused a dose reduction were arterial hypertension, proteinuria, diarrhea, fatigue, LPE, weight loss and loss of appetite. The most common adverse reactions leading to drug discontinuation included proteinuria, asthenia, hypertension, stroke, diarrhea, and pulmonary embolism.
The following are adverse reactions by class and organ system identified in 452 patients with differentiated thyroid cancer refractory to radioiodine in clinical trials.
The incidence was defined as very common (≥1/10); often (≥1/100 <1/10) and infrequently (≥1/1000 <1/100).
Within each frequency category, adverse reactions are presented in order of decreasing severity.
Infectious and parasitic diseases:
very often - urinary tract infection; infrequently - perianal abscess.
From the blood and lymphatic system:
very often - thrombocytopenia (including a decrease in the number of platelets in the blood); often - lymphopenia (including a decrease in the number of lymphocytes in the blood); infrequently - splenic infarction.
From the endocrine system:
often - increased TSH levels in the blood, hypothyroidism.
Metabolism and nutrition:
very often - loss of appetite, weight loss, hypocalcemia, hypokalemia; often - dehydration, hypomagnesemia (including a decrease in the level of magnesium in the blood), hypercholesterolemia (including an increase in the level of cholesterol in the blood).
Mental disorders:
very often - insomnia.
From the nervous system:
very often - headache, dizziness, dysgeusia; often - stroke; infrequently - monoparesis, transient cerebrovascular accident, reversible posterior encephalopathy syndrome.
From the heart:
often - prolongation of the QT interval, decreased ejection fraction, heart failure, myocardial infarction (including acute myocardial infarction)1.
From the side of blood vessels:
very often - arterial hypertension (including hypertensive crisis, increased blood pressure and increased blood pressure), arterial hypotension, bleeding (including epistaxis, hemoptysis, hematuria, bruising, hematochezia, bleeding gums, petechiae, pulmonary hemorrhage, rectal bleeding, the presence of blood in the urine, hematoma, vaginal bleeding, conjunctival bleeding, hemorrhoidal bleeding, hemorrhage into an intracranial tumor, laryngeal bleeding, ecchymosis, increased tendency to bruise, bleeding after medical procedures, purpura, skin hemorrhage, ruptured aneurysm, arterial bleeding, ocular hemorrhage, gastric bleeding, gastroduodenal bleeding, gastrointestinal bleeding, vomiting with blood, hemorrhagic stroke, melena, metrorrhagia, bleeding from the nail bed, pleural bleeding, postmenopausal bleeding, hemorrhagic proctitis, kidney hematoma, bleeding from the spleen, hemorrhages at the base of the nails, subarachnoid hemorrhage, bleeding from trachea, bleeding from tumor tissue)1; often - TELA1.
From the respiratory system, chest and mediastinal organs:
very often - dysphonia, cough.
From the gastrointestinal tract:
very common - diarrhea, oral inflammation (including aphthous stomatitis, stomatitis, glossitis, oral ulceration, inflammation of the mucous membranes), abdominal pain (including abdominal discomfort, lower abdominal pain, upper abdominal pain, abdominal tenderness on palpation, discomfort in the epigastric region), vomiting, nausea, pain in the oral cavity (including glossodynia, pain in the oropharyngeal region), constipation, dyspepsia, dry oral mucosa; often - rectal fistula, flatulence.
From the liver and biliary tract:
often - increased activity of AST, ALT, hypoalbuminemia, increased alkaline phosphatase activity, impaired liver function, increased GGT activity, increased bilirubin concentration in the blood; uncommon - liver cell damage/hepatitis (including drug-induced liver damage, hepatic steatosis, cholestatic liver damage).
For the skin and subcutaneous tissues:
LPE syndrome, rash, alopecia; often - hyperkeratosis.
From the musculoskeletal and connective tissue side:
very often - back pain, arthralgia, myalgia, pain in the extremities, musculoskeletal pain.
From the kidneys and urinary tract:
very often - proteinuria; often - episodes of renal failure (including acute prerenal failure, renal failure, acute renal failure, renal tubular necrosis)1, impaired renal function, increased concentration of creatinine in the blood, increased concentration of urea in the blood.
General disorders and disorders at the injection site:
very often - fatigue, asthenic syndrome, peripheral edema; often - a feeling of discomfort.
1 Including fatal cases.
Description of individual adverse reactions (see also “Special instructions”)
Arterial hypertension.
In the pivotal clinical trial, hypertension (including hypertensive crisis, increased blood pressure, and increased systolic blood pressure) was reported in 72.8% of patients receiving lenvatinib and 16% of patients receiving placebo. The median time to onset of hypertension in patients in the lenvatinib group was 16 days. Arterial hypertension of grade 3 or higher (including one clinical case of grade 4) occurred in 44.4% of patients receiving lenvatinib and in 3.8% of patients receiving placebo. In most cases, there was a decrease in severity or disappearance of the adverse event after temporary suspension of lenvatinib treatment (13% of patients) or reduction of the drug dose (13.4% of patients). In 1.1% of patients, arterial hypertension was the reason for complete discontinuation of lenvatinib.
Proteinuria.
In the pivotal clinical trial, proteinuria was reported in 33.7% of patients receiving lenvatinib and 3.1% of patients receiving placebo. The median time to onset of proteinuria was 6.7 weeks.
Grade 3 proteinuria occurred in 10.7% of patients receiving lenvatinib and in none of those receiving placebo. In most cases, there was a decrease in severity or disappearance of the adverse event after a temporary suspension of treatment with lenvatinib (16.9% of patients) or a reduction in the dose of the drug (10.7% of patients). Proteinuria was the reason for complete discontinuation of lenvatinib in 0.8% of patients.
Hepatotoxic effect.
During the pivotal clinical trial, the most common liver adverse reactions included hypoalbuminemia (9.6% of patients in the lenvatinib group and 1.5% of patients in the placebo group), increased liver enzymes - ALT (7.7% of patients in the lenvatinib group and 0 % of patients in the placebo group) and AST (6.9% of patients in the lenvatinib group and 1.5% of patients in the placebo group), as well as an increase in the concentration of bilirubin in the blood (1.9% of patients in the lenvatinib group and 0% of patients in the placebo group placebo). The median time to the onset of liver events in patients in the lenvatinib group was 12.1 days. Hepatic adverse events of grade 3 or higher (including one case of grade 5 liver failure) occurred in 5.4% of patients receiving lenvatinib and in 0.8% of patients receiving placebo. Adverse liver events led to temporary treatment interruption in 4.6% of patients, lenvatinib dose reduction in 2.7% of patients, and complete discontinuation of the drug in 0.4% of patients.
As a result of the analysis of the entire pooled set of data on the safety of lenvatinib in clinical trials (involving 452 patients with differentiated thyroid cancer refractory to radioiodine and 656 patients with other types of malignant tumors), 3 (0.3%) cases of hepatic failure with fatal outcome. One of them occurred in a patient with no liver metastases. One patient without liver metastases was also diagnosed with acute hepatitis.
Bleeding.
During the clinical trial, bleeding was reported in 34.9% of patients receiving lenvatinib and 18.3% of patients receiving placebo. Types of bleeding for which the incidence was ≥0.75% higher in the lenvatinib group than in the placebo group included epistaxis (11.9%), hematuria (6.5%), contusions (4.6%), bleeding from the gums (2.3%), hematochezia (2.3%), bleeding from the rectum (1.5%), hematomas (1.1%), hemorrhoidal bleeding (1.1%), bleeding from the larynx (1. 1%), petechiae (1.1%) and hemorrhage into a brain tumor (0.8%). The median time to first bleeding episode in patients in the lenvatinib group was 10.1 weeks. When comparing the lenvatinib group with the placebo group, there were no differences in the incidence of serious adverse events (3.4 and 3.8%), adverse events requiring early discontinuation of treatment (1.1 and 1.5%), and adverse events leading to lenvatinib interruption (3.4 and 3.8%) or dose reduction (0.4 and 0%).
As a result of the analysis of the entire pooled set of data on the safety of lenvatinib in clinical trials (including 452 patients with differentiated thyroid cancer refractory to radioactive iodine and 656 patients with other types of malignant tumors), 3 (0.3%) patients with bleeding of grade 4 and 5 (0.5%) patients with bleeding of grade 5, including 3 patients with differentiated thyroid cancer refractory to radioiodine (arterial bleeding, hemorrhagic stroke and hemorrhage into a brain tumor) and 2 patients with other oncological diseases (hemoptysis and bleeding from tumor tissue).
Hypocalcemia.
During the clinical trial, hypocalcemia was reported in 12.6% of patients receiving lenvatinib and in none of the patients receiving placebo. The median time to first detection of hypocalcemia in patients in the lenvatinib group was 11.1 weeks. Grade 3 or 4 hypocalcemia occurred in 5% of patients receiving lenvatinib and in none of those receiving placebo.
In most cases, hypocalcemia resolved with supportive treatment without requiring treatment interruption or dose reduction of lenvatinib (which occurred in 1.5% and 1.1% of patients, respectively). In one patient with grade 4 hypocalcemia, lenvatinib was discontinued.
Special patient groups
The influence of age.
Patients aged over 75 years were more likely to develop grade 3 or 4 hypertension, proteinuria, decreased appetite, and dehydration.
Influence of gender.
In female patients, there was an increased incidence of hypertension (including cases of grade 3 and 4), proteinuria and LPE, and in male patients there was an increased incidence of decreased ejection fraction, as well as cases of gastrointestinal perforation and fistula formation.
The influence of race.
Compared with Caucasian patients, Asian patients had a higher incidence of peripheral edema, fatigue, LPE, proteinuria, thrombocytopenia, and elevated TSH levels. Patients of Japanese ethnicity had an increased incidence of grade 3 or 4 hypertension, decreased appetite, fatigue, and thrombocytopenia compared with other populations.
Patients with a history of arterial hypertension.
Patients with hypertension were found to have higher rates of grade 3 or 4 hypertension, proteinuria, diarrhea, and dehydration, and tended to have more severe dehydration, hypotension, pulmonary embolism, and GI symptoms. (abdominal pain, diarrhea and vomiting).
Patients with impaired liver function.
Patients with liver dysfunction had a higher incidence of hypertension (including grade 3 and 4 cases) and LPE, as well as a higher incidence of asthenic syndrome, fatigue and hypocalcemia, compared with patients with normal liver function.
Patients with impaired renal function.
Patients with impaired renal function were more likely to experience adverse events such as grade 3 or 4 hypertension, proteinuria, fatigue, stomatitis, peripheral edema, thrombocytopenia, dehydration, QT prolongation, hypothyroidism, hyponatremia, and increased TSH levels ( compared to patients without renal impairment). In addition, these patients had a higher incidence of renal adverse events, and there was a trend towards an increased incidence of liver disorders.
Notification of adverse reactions.
It is extremely important to report adverse reactions that occur during post-registration use of the drug. This will allow you to control the benefit-risk ratio of its use. Please notify medical professionals of any adverse reactions to the address specified in this instruction.
Features of drug interactions
Vimovo interacts well with antiviral drugs
Effective interaction with antiviral drugs has been noted. It is recommended to take the substance included in the device in combination with aspirin with caution. Or it is recommended to take aspirin in small doses. There are no serious complications with the combination, but various undesirable side effects are possible.
When taking Vimovo with diuretics, the effectiveness of the latter is significantly reduced. This is due to the fact that prostaglandins are produced in much smaller quantities in this case. Cases of renal failure are also possible. In this regard, combining therapy with two such drugs must be done with caution.
It is not advisable to prescribe the drug simultaneously with Varafin, as this can lead to a number of undesirable complications.
It is not recommended to prescribe the drug simultaneously with corticosteroids, because bleeding on the side of the gastrointestinal tract is possible. In addition, drugs containing lithium must be limited, as when combined with Vimovo the level of toxicity increases.
VimovoTM (VimovoTM)
Elderly patients
Naproxen
: In elderly patients, an increased incidence of adverse reactions has been observed with the use of NSAIDs, in particular gastrointestinal bleeding, ulceration and perforation of the gastrointestinal tract, which can lead to death of the patient. In clinical studies of Vimovo™ in elderly patients, there was no increased incidence of gastric and duodenal ulcers compared with patients younger than 60 years of age, and the reduction in ulcer risk was maintained in this elderly patient population. However, ulcer complications such as bleeding, perforation and gastrointestinal obstruction were not studied in these studies of Vimovo™.
Effect on the gastrointestinal tract
Naproxen
: Gastrointestinal bleeding, ulceration or perforation of the gastrointestinal tract, which can lead to death of the patient, has been observed with the use of all NSAIDs at any time during treatment, with or without the development of symptoms of the lesion, with or without a history of serious gastrointestinal diseases. Vimovo™ contains esomeprazole to reduce the incidence of gastrointestinal side effects of naproxen, including ulceration. Although Vimovo™ significantly reduces the incidence of gastric ulcers compared to naproxen alone, the development of ulcers and accompanying complications is still possible. The risk of developing gastrointestinal bleeding, ulceration and perforation of the gastrointestinal tract when using NSAIDs increases with increasing dosages in patients with a history of ulcers, especially if the ulcer is complicated by bleeding or perforation, and in elderly patients. Such patients should be prescribed therapy with the lowest dosage.
Patients with a history of gastrointestinal adverse events, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) and especially at the beginning of treatment.
NSAIDs should be used with caution in patients already taking medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antithrombotic drugs such as acetylsalicylic acid.
If gastrointestinal bleeding or ulcers develop, use of Vimovo™ should be discontinued.
NSAIDs should be prescribed with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) due to a possible exacerbation of this disease.
Esomeprazole
: If any warning symptom develops (eg, significant, unintentional weight loss, recurrent vomiting, dysphagia, hematemesis, or melena) and there is a suspicion or certainty of developing a gastric ulcer, malignancy must be excluded, as esomeprazole magnesium may relieve symptoms and delay presentation diagnosis.
Treatment with proton pump inhibitors may slightly increase the risk of gastrointestinal infection with microorganisms such as Salmonella
and
Campylobacter
.
Effect on the cardiovascular and cerebrovascular systems
Naproxen: As with any NSAID, it is necessary to monitor and advise patients with a history of arterial hypertension and/or chronic heart failure, since NSAID therapy is accompanied by fluid retention and the development of edema.
Patients with uncontrolled hypertension, chronic heart failure, coronary artery disease, peripheral arterial disease and/or cerebrovascular accident should be prescribed naproxen only after careful evaluation. The same examination should be performed before starting long-term therapy in patients with risk factors for cardiovascular disease (for example, hypertension, hyperlipidemia, diabetes mellitus, smoking).
Based on clinical and epidemiological studies, naproxen therapy (1000 mg daily) may be associated with a lower risk of arterial thrombosis than selective COX-2 inhibitors, but this small risk cannot be excluded. Overall, the data do not support a cardioprotective effect.
Effects on the kidneys
Naproxen
: Long-term use of NSAIDs has led to the development of medullary necrosis and other kidney damage.
Nephrotoxicity has also been observed in patients in whom renal prostaglandins play a compensatory role in maintaining renal perfusion. In these patients, the use of NSAIDs may lead to a dose-dependent reduction in prostaglandin synthesis and, secondarily, a reduction in renal blood flow, which may precipitate the development of overt renal failure. The greatest risk of developing such a reaction is present in patients with impaired renal function, hypovolemia, heart failure, liver failure, with excessive excretion of sodium chloride from the body, in patients taking diuretics, ACE inhibitors or angiotensin II receptor antagonists, and in elderly patients. After discontinuation of NSAID therapy, the patient's condition usually returns to its original state.
Use in patients with renal failure
Since naproxen is largely (95%) eliminated by the kidneys via glomerular filtration, great caution should be used when administering it to patients with renal impairment, and monitoring of serum creatinine levels and/or creatinine clearance in these patients is recommended. It is not recommended to prescribe Vimovo™ to patients with an initial creatinine clearance of less than 30 ml/min.
Hemodialysis does not reduce plasma concentrations of naproxen due to high binding to plasma proteins. Certain patients, especially those with impaired renal blood flow due to depletion of interstitial fluid volume, cirrhosis of the liver, limited salt intake, chronic heart failure and pre-existing kidney disease, should have their renal function assessed before and while taking Vimovo™. Some elderly patients with suspected renal impairment, as well as patients taking diuretics, ACE inhibitors, or angiotensin II receptor antagonists, also fall into this category. To prevent possible excessive accumulation of naproxen metabolites in these patients, the daily dose of the drug should be reduced.
Effect on the hematopoietic system
Naproxen
: It is necessary to prescribe drugs containing naproxen with caution to patients with coagulation disorders or receiving therapy that affects hemostasis.
The risk of bleeding in patients at high risk of bleeding or receiving full anticoagulation therapy (for example, dicumarol derivatives) increases with concomitant use of drugs containing naproxen. Naproxen reduces platelet aggregation and prolongs bleeding time. This should be kept in mind when determining bleeding time.
If active or clinically significant bleeding develops in any area in patients taking Vimovo™, therapy should be discontinued.
Dermatological effects
Naproxen
: Very rarely, serious skin reactions have occurred with the use of NSAIDs, some of which have resulted in death, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The greatest risk of developing such reactions exists at the beginning of therapy, and in most cases the onset of such reactions occurs in the first month of treatment. At the first sign of skin rash, lesions of the mucous membranes or other symptoms of hypersensitivity, you should stop taking Vimovo™.
Effect on visual function
If visual disturbances occur while taking Vimovo™, consultation with an ophthalmologist is recommended.
Anaphylactic (anaphylactoid) reactions
Naproxen
: Hypersensitivity reactions may occur in susceptible patients. Anaphylactic (anaphylactoid) reactions may occur in patients with or without a history of hypersensitivity, or with or without hypersensitivity to acetylsalicylic acid, other NSAIDs, or naproxen-containing drugs. These reactions may develop in patients with a history of angioedema, bronchospasm (eg, bronchial asthma), rhinitis and polypous rhinosinusopathy.
Patients with bronchial asthma
Naproxen
: The use of acetylsalicylic acid in patients with aspirin-induced asthma was accompanied by the development of severe bronchospasm, which could lead to the death of the patient. Since cross-reactivity, including bronchospasm, between acetylsalicylic acid and other NSAIDs has been observed in patients with hypersensitivity to acetylsalicylic acid, it is not recommended to prescribe Vimovo™ to patients with such hypersensitivity to acetylsalicylic acid and use caution in patients with bronchial asthma.
Inflammation
Naproxen
: The antipyretic and anti-inflammatory properties of naproxen may reduce fever and other signs of inflammation, thereby reducing their usefulness as diagnostic factors.
Combinations with other drugs
It is not recommended to use Vimovo™ concomitantly with NSAIDs (other than acetylsalicylic acid), including selective COX-2 inhibitors, due to the cumulative risks of developing serious adverse events associated with NSAIDs.
According to the results of the studies, a pharmacokinetic/pharmacodynamic interaction was noted between clopidogrel (loading dose of 300 mg and maintenance dose of 75 mg/day) and esomeprazole (40 mg/day orally), which leads to a decrease in exposure to the active metabolite of clopidogrel by an average of 40% and reducing the maximum inhibition of ADP-induced platelet aggregation by an average of 14%. Therefore, the simultaneous use of esomeprazole and clopidogrel should be avoided (see section “Interaction with other drugs and other types of drug interactions”).
Fertility in women
Naproxen
: There is some evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may reduce fertility in women by affecting ovulation. This effect is reversible after discontinuation of therapy. In this regard, women who have problems conceiving or are undergoing examination for infertility should consider discontinuing Vimovo™ (see section “Use during pregnancy and breastfeeding”).
Are common
If the daily dose of naproxen 1000 mg is not acceptable, alternative treatment regimens should be used.
Patients receiving long-term therapy (especially more than 1 year) must be constantly monitored. Individual observational studies indicate that proton pump inhibitor therapy may modestly increase the risk of osteoporosis-related fractures, but other similar studies have not reported an increased risk.
Randomized, double-blind, controlled clinical trials of omeprazole and esomeprazole, including two open-label studies of long-term therapy (more than 12 years), did not confirm the association of osteoporotic fractures with the use of proton pump inhibitors.
Although a causal relationship between the use of omeprazole/esomeprazole and osteoporotic fractures has not been established, patients at risk of developing osteoporosis or osteoporotic fractures should be under appropriate clinical supervision.
