The Spanish Agency for Medicines and Health Products (AEMPS) has issued an information alert through its digital portal to inform that it has requested the “withdrawal from the market of all units” of a 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 medical devices, from their research to their use, in the interest of protecting and promoting human health, animal health and the environment. Among its main functions, it stands out “the continuous monitoring of the safety and efficacy of medicines once they are marketed and the control of their quality”, as well as “the supervision of the supply and supply of medicines”.
The agency has indicated that they have requested the withdrawal of the drug MICARDISPLUS 80mg/12.5mg tablets 28 tablets, a product that is used “for the treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled when telmisartan is used alone” (Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes your blood vessels to narrowthus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, so that the blood vessels relax and their blood pressure is reduced), indicates the AEMPS.
Specifically, the AEMPS describes the defect as a “typographical error in the dose that appears in the cartonage in some units of lot 944492 of the aforementioned medicine, appearing “Micardisplus 80/25 mg” instead of “Micardisplus 80/12.5 mg””. Therefore, the Spanish Agency for Medicines and Health Products has requested as a precautionary measure “withdrawal from the market of all units distributed of batch 944492 and return to the laboratory through the usual channels” and has requested the competent bodies of the autonomous communities to monitor the withdrawal.
The AEMPS ensures the safety of users by carrying out multiple controls on all the drugs that are distributed in Spain. Just a few days ago he ordered the withdrawal of . It has also requested that it be due to the “risk of congenital malformations in the fetus.”