The Spanish Agency for Medicines and Health Products (AEMPS) has issued an alert on one of the most consumed drugs in Spain to control blood pressure. Enalapril 20 milligram tablets, produced by Toll Manufacturing Services for Alter Laboratories, have been withdrawn from the market due to irregularities in test results for the evaluation of the product.
The drug, from which all units of the affected batch numbered 499R, with an expiration date of 31.07.2023, has been withdrawn, is used to treat hypertension and symptomatic heart failure in patients with asymptomatic left ventricular dysfunction. It is a widely known drug, which has been on the market for more than 30 years.
It is usually taken in tablets of different doses, with 20 milligrams being the maximum at the beginning of treatment for hypertension, although this depends on each individual patient.
In the case of heart failure, the starting dose is 2.5 milligrams and is adjusted over the next two to four weeks. In those with renal insufficiency or who are taking diuretics, special precautions should be taken.
Enalapril is contraindicated in patients with a history of angioedema associated with prior treatment with an ACE inhibitor (the family of drugs to which this drug belongs), hereditary or idiopathic angioedema, and in pregnant women during the second and third trimesters of pregnancy.
Among the most frequent adverse reactions of enalapril are dizziness, blurred vision, cough, and nausea, as well as fatigue, headache, chest pain, or hypotension. Less commonly, it can cause sleep disturbances, confusion, nervousness, or drowsiness.
