2024-07-16 14:00:00
he Bulletin on the Safety of Medicines for Human Use of May, published by the Spanish Agency for Medicines and Health Products (Aemps), including the new safety information obtained from the evaluation of the pharmacovigilance data for medicines for human use marketed in Spain.
The IS Amps reminds health care professionals of the importance of report suspected adverse reactions, since these help to update drug safety information and, therefore, reduce its risks. Such doubts can be expressed through the Autonomous Pharmacovigilance Center corresponding or the electronic form available.
The safety information specified below has, in some cases already been implemented and in other cases will soon be incorporated into the technical specifications and leaflets of the medicines containing the active ingredients mentioned:
Baclofen: encephalopathy. Cases of encephalopathy have been reported in patients receiving baclofen at therapeutic doses, which were reversible after discontinuation of treatment. Symptoms included drowsiness, decreased level of consciousness, confusion, myoclonus, and coma. If signs of encephalopathy are observed, baclofen treatment should be discontinued.
Baricitinib: hypoglycemia in diabetic patients. Cases of hypoglycemia have been reported following initiation of treatment with JAK inhibitors, including baricitinib, in patients receiving antidiabetic agents. The dose of antidiabetic medication may need to be adjusted if hypoglycemia occurs.
Buprenorphine: interactions, tolerance and opioid use disorder (abuse and dependence). Concomitant use of buprenorphine with gabapentinoids (gabapentin and pregabalin) may cause respiratory depression, hypotension, profound sedation, coma, or death. Concomitant administration of buprenorphine with anticholinergics or medications with anticholinergic activity (eg tricyclic antidepressants, antihistamines, antipsychotics, muscle relaxants and anti-Parkinson medications) may result in an increase in anticholinergic adverse effects.
Dapaglifozin: increased hematocrit. Some patients receiving dapaglifozin may experience an increase in hematocrit. When they present with pronounced elevations, they must be monitored and investigated for underlying haematological diseases.
Diclofenac topical: pregnancy. There are no clinical data on the use of topical diclofenac during pregnancy. Even if the systemic exposure is lower compared to oral administration, it is not known whether the systemic exposure of diclofenac achieved after topical administration could be harmful to the embryo or fetus. During the first and second trimester of pregnancy, topical diclofenac should only be used if absolutely necessary. If used, the dose and duration of treatment should be as short as possible.
More medications with adverse effects
These other five are also added to this Aemps list:
Leflunomide: skin reactions. During leflunomide treatment, disturbances in wound healing may occur in patients after surgery. Based on individual evaluation, discontinuation of leflunomide treatment in the perioperative period and implementation of a washing procedure may be considered. In the event of a break, the decision to resume leflunomide treatment will be based on clinical judgment regarding adequate wound healing.
Levofloxacin: myoclonus, blood disorders. Cases of myoclonus have been reported in patients receiving levofloxacin. The risk of myoclonus is increased in elderly patients and in patients with renal impairment if the dose of levofloxacin is not adjusted according to creatinine clearance. Levofloxacin should be stopped immediately at the first appearance of myoclonus and appropriate treatment is started for bone marrow failure, including leukopenia, neutropenia, pancytopenia, hemolytic anemia, thrombocytopenia, aplastic anemia or agranulocytosis, during treatment with levofloxacin. If any of these blood disorders are suspected, a blood count should be done. In case of abnormal results, discontinuation of levofloxacin treatment should be considered.
Manidipine: ascites. The use of manidipine in patients on peritoneal dialysis has been associated with the development of cloudy peritoneal effusion. Turbidity is caused by an increase in the concentration of triglycerides in the peritoneal fluid and often resolves after discontinuation of manidipine. It is important to recognize this association, since cloudy peritoneal effusion can be confused with infectious peritonitis, resulting in unnecessary hospitalization and empiric administration of antibiotics.
Posaconazole: photosensitivity, interactions. Patients should be advised to avoid sun exposure during treatment without adequate protection, such as protective clothing and sunscreen with a high sun protection factor. Flucloxacillin (a CYP450 inducer) may decrease posaconazole plasma concentrations. Concomitant use of posaconazole with flucloxacillin should be avoided unless the benefit to the patient outweighs the risk.
Teriflunomide: herpes infections. Cases of herpesvirus infections, including oral herpes and herpes zoster, have been reported, some of them serious, such as herpes meningoencephalitis and disseminated herpes with teriflunomide. They can occur at any time during treatment.
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