Drugs are essential in the treatment of diseases, but do you really understand these medicines that you use every day? Take you to take stock of the “pharmacovigilance” in cardiology to discover the risks of drug use.
1
simvastatin combined with amiodarone, the maximum daily dose was controlled at 20 mg
On December 15, 2011, the U.S. Food and Drug Administration (FDA) notified the public , the dose limit for simvastatin has been revised from 10 mg to 20 mg when simvastatin is co-administered with amiodarone. In June 2011, the FDA had recommended reducing the dose limit of simvastatin from 20 mg to 10 mg.
The FDA mentions: Simvastatin and amiodarone have a rare risk of rhabdomyolysis and can cause kidney failure or death. The odds of this risk are dose-related and increase when simvastatin doses exceed 20 mg. Therefore, when simvastatin is combined with amiodarone, the maximum dose of simvastatin should be controlled at 20 mg.
Clinical recommendations1. When the patient has unexplained myalgia, tenderness , fatigue, etc., or CK is greater than 10 times the upper limit of normal, stop simvastatin treatment in time. 2. Simvastatin not only interacts with amiodarone, but also interacts with many other drugs. In cardiology, it is more common to use simvastatin in combination with the antihypertensive drug amlodipine. Concomitant use of simvastatin and amlodipine increases simvastatin exposure, and patients taking amlodipine should limit the dose of simvastatin to less than 20 mg/day .
2
Notice the risk of cardiovascular events with NSAIDs strong>
I US FDA: Non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) increase heart disease Chances of seizure or stroke
On July 5, 2015, the FDA warned, Non-aspirin NSAIDs can increase the risk of heart attack or stroke.
NSAIDs are widely used to treat many different long-term and short-term ailments, such as arthritis, dysmenorrhea, headaches, pain and fever from colds and flu. The risk of heart attack or stroke can occur as early as the first few weeks of NSAID use. The risk may increase with long-term use of NSAIDs. The higher the dose, the greater the risk. NSAIDs can increase the risk of heart attack or stroke in people with or without heart disease or risk factors for heart disease. Numerous studies support this finding. Patients who were treated with NSAIDs after their first heart attack had a higher risk of Death is more likely in the first year after an attack. Additionally, the use of NSAIDs increases the risk of heart failure. (▲▼ swipe up and down to see full content)II Canada assesses high-dose ibuprofen risk of serious heart disease and stroke< span>
On April 23, 2015, Health Canada released the results of its safety assessment of oral ibuprofen. The conclusions are as follows:
1. There is evidence of an association between oral ibuprofen at doses of 2400 mg or more per day and an increased risk of adverse events related to heart attack and stroke association. The risk is similar to that of COX-2 inhibitors. At recommended doses, the overall benefits of ibuprofen still outweigh the risks. 2. Patients with ischemic heart disease, cerebrovascular disease, congestive heart failure, or with risk factors for cardiovascular disease should avoid oral ibuprofen at a daily dose of 2400 mg. 3. In safety assessments, there is no evidence that over-the-counter ibuprofen at maximum daily doses of 1200 mg or less increases the risk of cardiovascular disease. (▲▼ swipe up and down to view all content)III Canada Assessment of Cardiac and Stroke Risk Associated with Celecoxib
Health Canada conducted a safety review of all available evidence to assess the risk of celecoxib-related heart and stroke-related side effects compared with fen, naproxen.
The conclusions are as follows: Celecoxib (at doses above 200 mg/day) may be associated with an increased risk of serious cardiac and stroke-related side effects, and this Risks were similar to those associated with high-dose diclofenac (≥ 150 mg/day) or ibuprofen (≥ 2400 mg/day). (▲▼ swipe up and down to see full content)Assessment of heart and stroke risk associated with two NSAIDs (ibuprofen and celecoxib) compared to Canada In the United States, the cardiovascular risk warning of NSAIDs appears to be more cautious and conservative. The U.S. FDA considers this risk to be present with all non-aspirin NSAIDs and is associated with increased doses. Canada believes that the benefits of low-dose NSAIDs outweigh the risks and can be used with caution. Clinical Recommendations1. During the whole process of taking NSAIDs, medical staff should be vigilant about heart-related side effects. 2. Use of high-dose NSAIDs such as celecoxib ≥ 200 mg/day, diclofenac ≥ 150 mg, and ibuprofen ≥ 2400 mg should consider this risk. 3. Careful selection of lower doses of non-steroidal anti-inflammatory drugs is recommended in assessing cardiovascular risk, especially in patients with pre-existing risk factors for heart disease and the benefits of drug use.
3
Warfarin plus miconazole increases risk of severe bleeding
April 13, 2016 The Medicines and Medical Products Agency (MHRA) has warned that the use of topical miconazole in combination with warfarin increases the risk of serious bleeding.
The potential drug interaction between miconazole and warfarin is well established, and its mechanism of action is that miconazole Inhibition of the activity of the major cytochrome P450 isoenzyme (CYP2C9) involved in warfarin metabolism results in decreased clearance of warfarin and thus enhanced anticoagulation.
Clinical Recommendations
MiKang Miconazole (including topical gel formulations) can enhance the anticoagulant effect of warfarin when both azole and warfarin are used at the same time, so the anticoagulant effect should be closely monitored and the dose of warfarin should be reduced if necessary;
If a patient is receiving warfarin before using miconazole-containing medicines, including over-the-counter medicines, they should tell their doctor or pharmacist if excessive anticoagulation is observed during treatment Patients should be advised to seek immediate medical attention for signs of unexplained sudden bruising, epistaxis, or hematuria.
4
thiazide diuretics skin and eye risk
I UK warns of increased risk of non-melanoma skin cancer with long-term hydrochlorothiazide useNovember 14, 2018, UK The Medicines and Health Products Regulatory Agency (MHRA) has issued a message warning of a cumulative dose-dependent risk of non-melanoma skin cancer with long-term use of hydrochlorothiazide-containing products. Patients taking these products are advised to regularly check and report any suspected skin lesions or moles, limit exposure to sunlight and UV rays, and use sun protection. II Canada warns of increased risk of non-melanoma skin cancer with long-term hydrochlorothiazide useOn January 31, 2019, Health Canada issued information warning that long-term use of hydrochlorothiazide may increase non-melanoma skin cancer risk cancer risk. III EU alerts on the risk of choroidal effusion with thiazides and thiazide-like diureticsApril 6, 2020, European Medicines Agency (EMA) Pharmacovigilance Risk Assessment The Committee (PRAC) issued information warning of the risk of choroidal effusion with thiazides and thiazide-like diuretics and their combination products. Clinical RecommendationsAs long-term use of hydrochlorothiazide increases the risk of non-melanoma skin cancer, it is recommended that: 1. potential risk of melanoma skin cancer, and recommends regular inspection and reporting of new skin lesions and changes in existing lesions. 2. Advise patients with previous skin cancer to reconsider the use of hydrochlorothiazide. 3. It is recommended that patients take measures such as limiting sun exposure time and avoiding sunlight exposure. Avoid using equipment that tans your skin. Due to the risk of choroidal effusion with thiazides and thiazide-like diuretics, it is recommended that: Before taking the drug, inform patients that if they experience decreased vision or eye pain, this may be due to fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which can occur within hours to weeks after taking this medicine, tell the patient to seek medical attention.
Patients with a history of allergy to penicillin or sulfonamides are at higher risk for these adverse reactions.
5
Risk of aortic aneurysm rupture and dissection with fluoroquinolones
December 20, 2018 US Food and Drug Administration (FDA) Evaluation Finds Fluoroquinolone Antibiotics Increase Rare and Serious Rupture of Aortic Aneurysm or risk of dissection. Ruptured aortic aneurysm or aortic tear (also called aortic wall dissection), which can lead to bleeding risk and even death, and systemic (oral, injectable) fluoroquinolone antibiotics can this risk occurs. Fluoroquinolones have been used as synthetic antibacterial drugs for nearly 40 years. They are mainly used to treat bacterial infections in the urinary tract, intestinal tract, respiratory tract, skin and soft tissue, abdominal cavity, and osteoarthritis. Children under the age of 18 are prohibited from use. Four generations have been developed so far. The FDA mentions: Certain patients have aneurysms, including older adults and those with a history of blocked arteries or other blood vessels, high blood pressure, or certain genetic disorders that involve changes in blood vessels. Although the risk of aortic aneurysm rupture or dissection was low, we observed that patients taking fluoroquinolones were twice as likely to have aortic aneurysm rupture or dissection than those not taking fluoroquinolones.
Clinical Recommendations
1. Fluoroquinolone antibiotics are prescribed in patients with aneurysms or at risk for aneurysms, including:peripheral atherosclerotic vascular disease, hypertension, certain genetic disorders such as Marfan syndrome and Ehlers-Danlos syndrome) and elderly patients.
2. The above patients should be given fluoride onlyif there are no other treatment options Prescription of quinolones.
6
Summary
Any drug use is a double Blades can only be used by us if we have a good grasp of its indications, usage and dosage, contraindications, etc., and at the same time properly understand its possible potential risks. Whether the sword is used well or not depends on whether the person using the sword has evaluated its benefits and risks. Blindly emphasizing the therapeutic effect, while ignoring risk factors such as adverse reactions and interactions, the consequences are self-evident. This article cannot list all the pharmacovigilances of cardiology, and aims to introduce some common drugs. I hope to be helpful.
Planning:lySubmission: [email protected]Source of title map: Station Cool Hero