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The National Health Surveillance Agency (Anvisa) announced today an alert aimed at increasing the risk of non-melanoma skin cancer resulting from the cumulative use of the drug. hydrochlorothiazide, a drug used to treat hypertension and to control edema. "
" The conclusions were drawn from epidemiological studies demonstrating a cumulative dose-dependent badociation – which occurs when the dose of a given drug is directly related to its effects – between the drug in question and skin cancer. "
According to the agency, in one of the studies, it was possible to note a possible badociation between lip cancer and drug exposure." Photosensitizing actions of the 39, hydrochlorothiazide, which facilitate its uptake through the skin, may be a possible mechanism of the disease. "
Anvisa also reviewed the recommendations of the Agency's Pharmacovigilance Risk Assessment Committee. The badociation between the increased risk of non-melanoma skin cancer and the long-term use of hydrochlorothiazide-containing medicinal products is plausible.
Recommendations
The agency has asked health professionals to inform patients treated with hydrochlorothiazide about the risk of skin cancer – especially those who are already using the drug over the long term. They should be advised to regularly check the skin for new lesions and to inform the professional immediately of any suspected skin lesions.
Anvisa recommends not to stop treatment until patients see a doctor. "Suspected skin lesions should be examined promptly, including histological examination of biopsies." Preventive measures, such as limiting exposure to the sun and ultraviolet light, can be implemented to minimize the risk of skin cancer.The use of hydrochlorothiazide may be reconsidered in patients with a history of skin cancer other than melanoma. "
The inclusion of new information in the leaflets of all medicinal products containing the active substance hydrochlorothiazide will be immediately requested by the Agency [19659002] Cancer of the skin
Non-melanoma skin cancer includes the most common tumors, that occur mainly in fair-skinned people after prolonged exposure to the sun. Generally, they only show local growth, but do not heal without treatment and tend to increase over time, causing deformities, pain and bleeding.
Data from the National Cancer Institute (INCA) indicate that there is the type of cancer in Brazil and accounts for 30% of all malignancies registered in the country. If detected early, the disease has high percentages of cure. Surveillance
Anvisa indicated that she was constantly monitoring the drugs marketed in Brazil and that she was reinforcing the fact that professionals have a higher incidence and lower mortality rates . (19659002) Communication of suspected adverse events by patients can be made via the form, the Public Assistance Center (0800 642 9782) or the Office of the Ombudsman. (ouvidori @ tende)
For health professionals, Anvisa provides the Notivisa system in case of notification of adverse events.
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