A drug that is widely used in Serbia because it is given to almost all patients with hypertension and hydrochlorothiazide may cause so-called Nelanoma skin cancer, the latest warning from the Medicines Agency and Medical Devices (ALIMS) to all healthcare workers in the country, writes Blic.
At this top Serbian pharmacy, they informed that patients who are taking this medicine are following all the changes on their skin, and immediately inform their doctor if they notice unusual occurrences.
Cardiologists say that this medicine prescribes the treatment of high blood pressure with other treatments to remove excess fluid from the body. The medicine belongs to so-called diuretics, the effect of which is to remove excess fluid from the body by lowering the blood pressure and reducing the isotope that results from the maintenance of this fluid.
WHOLE POLYESTER HYPOTHESIS
According to the same data, the initial dose for hypertension is 12.5 milligrams and can be progressively increased until the desired result is achieved. Recent statistics indicate that high blood pressure is caused by half of the adult population in Serbia, which is about 47 percent, while more than 50,000 people die from heart disease and blood vessels each year.
Because of such a wide use, the agency sent a letter to health workers on Tuesday about the risk of "non-melanoma skin cancer associated with hydrochlorothiazide" on Tuesday, along with marketing authorization holders.
They confirmed this in ALIMS for Blic, and in the statement to healthcare professionals it is said that pharmacoepidemiological studies have shown that there is an increased risk of non-melanoma skin cancer – basal cell and planocellular carcinoma when exposed to high cumulative doses of this drug.
– Patients who are taking hydrochlorothiazide alone or in combination with other medicines should be informed about the risk of non-melanoma skin cancer and advised them to periodically examine the skin due to the possible development of new lesions, ie skin lesions or changes in existing lesions, and immediate tell your doctor about any suspected skin lesion – says ALIMS warning Blic had a look at.
TEST THE SKIN SUMMARY
As further informed about healthcare workers, suspicious skin phenomena should be immediately investigated and, if necessary, a sample of such change may be performed for histological examination. In addition, doctors advise patients to reduce burns and exposure to UV radiation, it is essential that physicians "carefully consider the use of hydrochlorothiazide in patients who have previously had skin cancer."
ALIMS reminded doctors that they should report any suspected adverse reaction to the National Pharmacovigilance Center or adverse drug reactions.
CAN BE REMOVED FROM USE
Prof. Dr. Miljko Ristic, a famous Serbian cardiologist, says this drug is widely used and is being administered to hypertensive people.
– It's one of the classical drugs that have been administered in recent years, and even longer, in the treatment of hypertension. All medicines used to treat high blood pressure, but also other illnesses have side effects. It is recorded regularly and their frequency is recorded. It is the responsibility of their manufacturers to inform users or patients about them. Depending on how many and what kind of side effects the drug has, it can be discarded from use – explains prof. Dr. Miljko Ristić.
NEVER BE A PRODUCT WITH THE MARKET
According to him, this medicine may still be used because it has not been withdrawn from the market, and medicines used to remove fluid from the body in hypertensive patients are essential.
– The Medicines Agency should inform citizens who are alternative drugs and who have a market – says prof. Dr. Ristic.
As he explains, it is good that ALIMS called on health workers to report any suspected occurrence during drug use, because if skin cancer is detected in time, it can be curable.
– Patients with cardiovascular disease also have hypertension because the disease is just the illness. We have been in Europe for decades in the number of deaths for cardiovascular disease. In Serbia, about 55 percent of patients die for cardiovascular disease, while 45 percent of them come from all others – says prof. Dr. Ristic.
According to EMA, the Risk Assessment Committee of the European Medicines Agency (EMA) has reviewed the available data sources from two recently conducted pharmacoepidemiological studies with Danish national data sources, including the Danish Malignancies Register and the National Medical Registry, showing that, depending on the cumulative dose, relationship between the use of hydrochlorothiazide and non-melanoma skin cancer.
An example is that a cumulative dose of 50,000 milligrams corresponds to a dose of 12.5 milligrams of hydrochlorothiazide a day, given regularly for 11 years. And that is, as stated in the drug guidelines, the initial dose given to patients.