The (AEMPS), as a state agency attached to the Ministry of Health, Consumption and Social Welfare, is responsible for guaranteeing to society, from the perspective of public service, the quality, safety, efficacy and correct information of medicines and health products, from its research to its use, in the interest of protecting and promoting human health, animal health and the environment.
This agency’s main objective is to inform both the public and those responsible for healthcare or pharmacists if they have detected any that are marketed or used in hospitals.
The AEMPS through its digital portal to report that there have been cases of pancreatitis related to two drugs: carbimazole and thiamazole. “Carbimazole and thiamazole are two antithyroid drugs indicated in situations in which a reduction in thyroid function is necessary, such as hyperthyroidism, thyrotoxic crises, or preparation for thyroidectomy, among others (see specific indications in the Neo-tomizol and Tirodril data sheets Carbimazole is a prodrug that is completely converted to thiamazole once administered, which acts by inhibiting the synthesis of thyroid hormones. The available information regarding the risk of acute pancreatitis has recently been evaluated. in patients treated with both drugs, as well as that related to the risk of congenital malformations associated with their use during pregnancy,” they point out.
The AEMPS recommends that those who are taking this medication suspend treatment. “Cases of acute pancreatitis have been reported with the use of carbimazole/thiamazole. In most cases, the suspension of treatment improved the clinical situation of the patient. In addition, in many of the cases in which treatment was subsequently restarted, a new episode of pancreatitis occurred with a shorter time to onset of symptoms. Although the exact mechanism by which pancreatitis occurs is not known, the shorter latency time after re-exposure to the drug suggests an immunological mechanism. Patients who develop acute pancreatitis during treatment with carbimazole/thiamazole should immediately discontinue treatment and not be treated again with these drugs.”
The agency has also issued for healthcare professionals:
“In the case of acute pancreatitis during treatment with carbimazole/thiamazole, discontinue treatment and not re-treat the patient with these drugs.
“Avoid the use of carbimazole/thiamazole during pregnancy if possible. If treatment is essential during pregnancy, use the minimum effective dose and carry out close maternal, fetal and neonatal monitoring.
“Warn at women with gestational capacity of the need to use effective contraceptive methods throughout the treatment and to come to the consultation in case they wish to plan a pregnancy.