The Spanish Agency for Medicines and Health Products (AEMPS), under the Ministry of Health, advises to monitor the use of some type 2 sodium-glycose collection inhibitors (SGLT2) as a treatment for type 2 diabetes before the possible risk of ketoacidosis,A serious complication commonly associated with type 1 diabetes.
The alert occurs after the Committee for Risk Assessment in European Pharmacovigilance (PRAC) has analyzed the risk of this disorder associated with oral treatment with Canagliflozine ('Invokana', by Janssen), Dapagliflozina ('Ebymect', 'Edistride' and 'Forxiga', from Astrazeneca) and Pagliflozina ('Jardiance', by Boehringer Ingelheim).
Although the mechanism by which SGLT2 inhibitors would produce diabetic ketoacidosis is not established, the available data suggest that they could favor the appearance of ketosis in situations in which there is a low insulin reserve.
In addition, a particularly susceptible group of patients would be those with latent adult autoimmune diabetes (lada), which are usually diagnosed as type 2 diabetics.
Diabetic ketoacidosis in patients treated with SLGT2 inhibitors can occur atypically, so the diagnosis should also be considered in patients with type 2 diabetes mellitus, before nonspecific symptoms and blood glucose below 250 mg/dl.
Given this situation, the AEMPS reminds health professionals that the risk of diabetic ketoacidosis in these patients should be considered in the presence of nonspecific symptomatology, such as nausea, vomiting, abdominal pain, anorexia, excessive thirst, dyspnea, confusion, or tiredness or drowsinessunusual even with blood glucose levels less than 250 mg/dl.
Patients should be informed about suggestive symptoms, and recommend that they look for medical care if they appear.
And if the diagnosis of ketoacidosis is suspected, the treatment must be suspended and the determination of ketone bodies.The situations that can predispose are those already known to the disease such as dehydration, restriction of caloric intake, weight reduction, infections, surgery, vomiting, reduction of insulin dose, poor control of diabetes, or alcohol intake.These factors must be taken into account at the beginning and during treatment with a SGLT2 inhibitor.
The treatment should not be repeated
Patients who have had a ketoacidosis during treatment with SGLT2 inhibitors should not be reintroduced the treatment, unless there are other factors that have been clearly precipitating and they have been resolved.
And in case of patients hospitalized by major surgery or severe medical disease, treatment with these drugs should be interrupted until the situation is resolved.
On the other hand, patients in treatment advise not to stop taking it without previously consulting with their doctor since "it can lead to a decompensation of their diabetes."
And in the case of appearance of symptoms that could make them think that they are suffering a picture of diabetic ketoacidosis (for example: nausea, vomiting, abdominal pain, excessive thirst, difficulty breathing, marked tiredness, drowsiness) must immediately contact aDoctor, also to consult any questions about the treatment.
