The drug, commonly used in Serbia because it is given to almost all patients with high blood pressure and hydrochlorothiazide, can cause non-melanoma hip cancer, the latest warning from the Medicines and Medical Equipment Agency (ALIMS) to all healthcare professionals in the country, writes Blic.
In this highest serbian medicine institution, they recommended that patients who drink this drug monitor all skin changes and immediately inform the doctor if they notice unusual events.
Cardiologists say that this medicine with the rest of the treatment prescribes treatment of high blood pressure to eliminate excess body fluid. The drug belongs to the so-called diuretics whose effect is manifested by removing excess fluid from the body by lowering blood pressure and reducing the isotope resulting from retention of this fluid.
ANY HELP OF HYPER TENSION TREATMENT HAT
According to the same data, the initial dose for high blood pressure is 12.5 milligrams, and it can gradually increase until the desired result is achieved. New statistics say that in Serbia, high blood pressure is caused by half of the adult population, about 47 percent, whereas more than 50,000 people die from heart disease and blood vessels each year.
Just because of such a large use, the Agency sent a letter to healthcare professionals about the risk of skin cancer with melanoma associated with the use of hydrochlorothiazide on Tuesday with the licensees to place this drug on the market.
They confirmed this in ALIMS for Blic, and in a message to healthcare professionals, it is said that pharmacoepidemiological studies have shown that there is an increased risk of skin cancer in non-melanoma-basocellular and planocellular carcinoma when exposed to high cumulative doses of this drug.
– Patients who use hydrochlorothiazide alone or in combination with other drugs should be informed of the risk of skin cancer from melanoma and advise them to regularly check the skin due to possible development of new injuries, ie skin damage or changes in existing damage, and immediately inform your doctor if any suspected skin damage – says ALIMS warning, as Blic had insight.
OVERVIEW SUMMARY OF THE SKIN
As further informs health workers, suspected skin phenomena should be investigated immediately and, if necessary, a sample of such a change for a histological examination may be taken. In addition to advising doctors to tell patients to limit tanning and exposure to UV rays, it is necessary for doctors to "carefully consider the use of hydrochlorothiazide in patients who have previously had skin cancer".
ALIMS reminded physicians that they should report suspicions of side effects to the National Center for Pharmacovigilance or Side Effects.
CAN BE CARRIED OUT OF USE
Prof. Dr Miljko Ristic, the famous Serbian Heart Surgeon, says that this medicine is widely used and given to people who are hypertonic.
"It's one of the classic drugs given in recent years, and even longer, for the treatment of high blood pressure. All medicines used to treat high blood pressure, but also other diseases, have side effects. It is recorded regularly and their frequency is noted. The manufacturer's obligation is to inform users or patients about it. Depending on how much and what type of side effects the drug has, it can be withdrawn from use – explains Prof. Dr Miljko Ristić.
NONE IS SECURITY WITH THE MARKET
According to him, this drug can still be used because it has not been withdrawn from the market, and medicines used to remove fluid from the body in patients with high blood pressure are necessary.
– The Swedish Medicines Agency will inform citizens who are alternative medicines and which they have on the market – says Prof. Dr Ristic.
As he explains, ALIMS has called healthcare professionals to report any suspected events while using the drug because it can be heard if skin cancer is detected on time.
– Patients with cardiovascular disease also have high blood pressure because it is just the cause of these diseases. We have been in Europe for decades in the number of deaths from cardiovascular disease. In Serbia, about 55 percent of patients die from cardiovascular disease, while 45 percent of them die from all others – says Prof. Dr Ristic.
According to EMA, the Risk Assessment Committee of the European Medicines Agency (EMA) has evaluated the available data sources for two pharmacoepidemiological studies, recently conducted, with Danish national data sources, including the Danish Malignancy Disease Register and the National Register of Medical Prescriptions, that, depending on the cumulative dose , there is a link between the use of hydrochlorothiazide and non-melanoma skin cancer.
For example, a cumulative dose of 50,000 mg corresponds to a dose of 12.5 mg hydrochlorothiazide daily, administered regularly for 11 years. And, as stated in the instructions for the drug, the initial dose is given to patients.