New data on the cardiovascular safety of ibuprofen

British doctors have reported serious side effects from the popular painkiller ibuprofen. Experts noted that it can cause dizziness, headaches, nausea, indigestion and even poses a risk of gastrointestinal bleeding and blurred vision. But you need to be careful with any painkillers.

The side effects of ibuprofen were reported to the UK National Health Service. Doctors found that “more than one person” in 100 experienced negative symptoms after taking ibuprofen. Some had a stronger headache, others felt dizzy, felt nauseated and had indigestion.

But the biggest problems are the risk of gastrointestinal bleeding and visual impairment. In some cases, an allergic reaction is also possible.

The negative aspects of ibuprofen have been written about before. For example, in December 2021, Dr. Alexander Myasnikov said that drugs based on ibuprofen or analgin can cause stroke, heart attack or hypertension. These substances are especially contraindicated for people over 60 years of age.

In March 2020, the World Health Organization announced the dangers of self-administration of ibuprofen in the treatment of coronavirus, noting the risks of internal bleeding.

However, medical experts warned that any substance should be treated with caution. It is best not to self-medicate, but to turn to professionals.

Relevance

The results of the PRECISION-ABPM study were presented at the European Congress of Cardiology held in Barcelona.
The analysis found that ibuprofen was associated with increased blood pressure (BP) and hypertension compared with celecoxib in patients with osteoarthritis and rheumatoid arthritis. Nonsteroidal anti-inflammatory drugs (NSAIDs), both selective COX-2 inhibitors and non-selective drugs, are widely prescribed by doctors of all specialties. Thus, in developed countries, about 20% of individuals take at least one NSAID on a regular basis, and if we remember that the incidence of arterial hypertension in the general population is 40%, then the problem becomes of great importance.

Official position of WHO and the Ministry of Health of the Russian Federation

A few days later the situation became clearer and a refutation was issued.

On March 19, the European Medicines Agency noted that there is no scientific evidence establishing a link between ibuprofen and worsening symptoms of coronavirus.

A WHO statement dated March 19 said that after analyzing information and consulting with doctors who treat patients with coronavirus, there is no reliable data on new negative effects of ibuprofen in this category of patients. Restrictions apply only to side effects that have been known for a long time for certain groups of people and diseases. Therefore, WHO does not put forward any additional restrictions on the use of ibuprofen.

WHO does not put forward any additional restrictions on the use of ibuprofen.

The Russian Ministry of Health also made an official statement that in patients with COVID-19, ibuprofen can and should be used along with paracetamol. Elena Malinnikova, chief infectious disease specialist at the Ministry of Health of the Russian Federation, clarified that it is important to follow medical recommendations. Only the doctor determines the effective drug and treatment tactics for a particular patient.

And today, 3 months later, British doctors plan to try a special form of ibuprofen in patients with severe symptoms of COVID-19 to combat respiratory failure.

Recommendations change every day. Let’s try to form a balanced opinion about whether it is possible to drink ibuprofen during coronavirus.

PRECISION-ABPM Study

The PRECISION-ABPM study is part of the larger PRECISION study. The researchers assessed the effect of the NSAIDs celecoxib, naproxen and ibuprofen on blood pressure levels over a 4-month period.

PRECISION-ABPM is a double-blind, randomized, non-inferiority study. The study was conducted at 60 centers in the United States and included 444 patients, of whom 408 (92%) had osteoarthritis and 36 (8%) had rheumatoid arthritis.

Patients were randomized in a 1:1:1 ratio to receive celecoxib (100–200 mg twice daily), ibuprofen (600–800 mg three times daily), or naproxen (375–500 mg twice daily).

The primary endpoint was the change in blood pressure after 4 months of therapy (outpatient 24-hour blood pressure monitoring).

Ibuprofen MAX, tablets

Use internally, preferably between meals. In order to minimize the risk of adverse reactions, ibuprofen should be taken in the minimum effective dose and for the shortest period necessary to achieve a clinical effect.

Ibuprofen MAX is prescribed to adults, as well as to children over 12 years of age and weighing 40 kg or more.

The dosage regimen is set individually and depends on the indications. Typically, adults and children over 12 years of age (whose body weight is 40 kg or more) ibuprofen are prescribed at an initial dose of 400 mg 1-2 times a day; if necessary, the dose can be increased to 400 mg 3 times a day to achieve a therapeutic effect. It is not recommended to take more than 3 tablets in 24 hours (1200 mg).

If you miss the next dose of the drug, it is recommended to take the dose in accordance with the prescribed dosage regimen, without doubling the amount of the drug.

Patients with kidney failure

Based on pharmacokinetic data, no dose reduction is required in patients with mild to moderate renal impairment (creatinine clearance 30–80 ml/min). In severe renal failure (creatinine clearance <30 ml/min), ibuprofen is contraindicated.

Patients with liver failure

In patients with mild to moderate liver dysfunction, no dose reduction is required (use in severe liver failure is contraindicated).

Elderly patients

No special dose adjustment is required if renal function is preserved. However, given that older adults are at increased risk of serious adverse reactions, it is recommended that the lowest effective therapeutic dose be administered for the shortest possible duration. During treatment, regular monitoring is necessary to avoid gastrointestinal bleeding. If renal function is impaired, the dosage should be adjusted individually. If treatment is required for more than 7 days, regular monitoring of renal function is required.

Children

Given that the maximum daily dose of ibuprofen in children is 20 mg/kg, it is not advisable to prescribe ibuprofen 400 mg tablets to children and adolescents weighing less than 40 kg and under 12 years of age.

If ibuprofen is required for more than 3 days or symptoms worsen in adults, children and adolescents 12 to 18 years of age, you should consult your doctor.

results

  • The analysis showed that celecoxib reduced mean 24-hour systolic blood pressure by -0.3 mmHg. Art., while ibuprofen and naproxen increased by 3.7 and 1.6 mmHg. Art., respectively. The difference between celecoxib and ibuprofen was statistically significant (p=0.009).
  • Additional analysis demonstrated that the percentage of patients with normal BP at baseline who were subsequently diagnosed with hypertension was 23.2 in the ibuprofen group, 19.0 in the naproxen group, and 10.3 in the celecoxib group (odds ratio, 0.39; p =0.004 for celecoxib ibuprofen and 0.49 p=0.03 for celecoxib vs. naproxen).

Ibuprofen and coronavirus

Ibuprofen cannot be used as a prophylactic against coronavirus. It also does not kill the virus during illness. It acts only on the symptoms, relieving inflammation, pain and fever, which alleviates the patient's condition. Ibuprofen can be used along with paracetamol. Some combination drugs contain both at the same time.

The active ingredient ibuprofen can have different forms (tablets, suspensions, suppositories, gels, ointments) and different trade names:

  • Nurofen Express;
  • Nurofen for children (suspension from 3 months);
  • Brufen SR;
  • Teraflex Advance (for joints, combination with chondroprotectors);
  • Brufica Plus (suspension, combination with paracetamol for children over 2 years old);
  • Nurofen Long (ibuprofen + paracetamol from 12 years);
  • Ibuprofen suppositories (for children).

Other traditional NSAIDs will be analogues of ibuprofen.

However, paracetamol is not an absolutely safe medicine. It is a common cause of acute high-dose poisoning with subsequent hospitalization in the USA and Great Britain1.

It is not recommended to lower the temperature until it is above 38.5 C and is comfortably tolerated by the body.

Discussion

The principal investigator, Prof Ruschitzka (Switzerland, Zurich) noted that the increase in cardiovascular risk during NSAID therapy is in particular associated with drug-mediated increases in blood pressure. This position challenges the well-known hypothesis that the adverse cardiovascular effects of NSAIDs are directly related to effects on platelets and endothelial cells.

It is important to remember that the decrease in systolic blood pressure is only 2 mmHg. Art. is associated with a 10% reduction in mortality from stroke and a 7% reduction in mortality from coronary heart disease.

Source:

European Society of Cardiology Congress. August 28, 2021.

Ibuprofen FT (suspension)

    The assessment of undesirable effects is based on the following frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1 /10,000 to <1/1000), very rare (<1/10,000), unknown (cannot be estimated from available data). When using the drug IBUPROFEN for 2-3 days, practically no side effects are observed. In case of long-term use, the following side effects may occur: Infections and infestations: Very rarely: exacerbation of the inflammatory process caused by infection (for example, the development of necrotizing fasciitis), the appearance of symptoms of aseptic meningitis with the manifestation of tension in the neck muscles, headache, vomiting, fever. From the immune system: Uncommon: hypersensitivity reactions may occur, which can be divided into: - nonspecific allergic reactions, anaphylaxis; - reactions of the respiratory tract, for example, asthma, exacerbation of asthma, bronchospasm, shortness of breath; - various skin reactions, for example, itching, urticaria, Quincke's edema, less often exfoliative and bullous dermatosis (including epidermal necrolysis and erythema multiforme). From the gastrointestinal tract: Uncommon: abdominal pain, nausea, dyspepsia; Rarely: diarrhea, flatulence, diarrhea, vomiting; Very rare: ulceration of the mucous membrane of the gastrointestinal tract (in some cases complicated by perforation and bleeding), abdominal pain, dryness of the oral mucosa, aphthous stomatitis, exacerbation of colitis, Crohn's disease, pancreatitis, constipation, hepatitis. From the central nervous system: Uncommon: headache; Very rare: dizziness, sleep disturbance, insomnia, psychomotor agitation, irritability or fatigue; Rare: aseptic meningitis (more often in patients with autoimmune diseases). From the senses: Uncommon: visual disturbances (blurred vision or diplopia), dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic origin); Rare: hearing loss, ringing or noise in the ears. From the hematopoietic organs: Very rarely: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia. From the cardiovascular system: Very rarely: development or worsening of heart failure, tachycardia, increased blood pressure (BP). Long-term use of ibuprofen (especially at high doses of 2400 mg per day) may be associated with a slight increase in the risk of arterial thrombosis (myocardial infarction, stroke). From the urinary system: Very rarely: nephrotic syndrome (edema), acute renal failure, allergic nephritis, polyuria, cystitis, increased serum concentrations in the urine. Allergic reactions: skin itching, skin rash (erythematous or urticaria), angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia , allergic rhinitis. Other: increased sweating. With long-term treatment in large doses - ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (impaired color vision, scotoma, amblyopia). If any side effects occur, you should stop taking the medicine and consult your doctor.
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