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Objective: To assess the effectiveness of erythropoietin use in hematologic patients; to analyze the extent to which recommendations are applied as provided by Spanish prescribing information, American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH) guidelines, as well as specific recommendations for myelodysplastic syndromes (MDSs), and to perform a descriptive analysis of costs. Method: A descriptive retrospective study. Patient selection was performed by Unidad de Atencion Farmaceutica a Pacientes Externos (UFPE: Pharmaceutical Outpatient Care Unit) during a 3-month period of time. Follow-up was performed to month 9 after selection. Results: Thirty-six patients (37% males) were included. In the group of patients with multiple myeloma and lymphomas, effectiveness was 57%; while in the MDS group it was 45-64% (depending on criteria used to measure erythroid response). Of all 24 patients (MDSs excluded) only 4 (17%) met indication criteria – adjustment to erythroid response at 4 and 8 weeks, and dosage titration when needed. Continued treatment with erythropoietin in all non-responders amounted to 59-69% of total expense for nonresponders. Conclusions: There is a high percentage of therapy failures and inconsistency between erythropoietin use recommendations and clinical practice. This circumstance, as well as the high financial impact it entails, makes it essential that monitoring and follow- up strategies are implemented to contribute to an optimal usage of erythropoiesis stimulating factors.

Summary Objective: To assess the teratogenic risk associated with leflunomide during the first quarter of pregnancy, and to establish guidelines to minimize said risk. Method: Literature search using tertiary, secondary, and primary sources related to teratogenicity, including databases (MEDLINE and EMBASE) and specific webs. The information required for assessment, as well as for the establishment of criteria was collected. Results: Leflunomide demonstrated an increased risk of fetal death and teratogenic effects in animals. No major or minor malformation cases have been reported in humans regarding leflunomide, which is classified within category X of fetal risk. A wash-out regimen may possibly reduce the risk for fetal harm. Conclusions: Conception scheduling or early pregnancy detection is required for better clinical counselling and the avoidance of unnecessary risk.

Objective: To report a case of fetal exposure to pyridostigmine and 3,4-diaminopyridine (3,4-DAP) in a pregnant woman with congenital myasthenia syndrome (CMS). Case Summary: A 31-year-old woman with postsynaptic CMS, not genetically characterized, was being treated with pyridostigmine and 3,4-DAP. She decided to become pregnant, despite having been informed about the paucity of available information on the possible risks of these drugs for the fetus. The dose of pyridostigmine remained stable throughout the pregnancy (60 mg every 8 h), and the 3,4-DAP dose was adjusted according to the patient's level of fatigue (20 mg/day, with occasional additional doses of 5 mg). At 25 weeks' gestation, ultrasonography confirmed the presence of only one umbilical artery. The results of other tests were normal. At 38 weeks' gestation, a healthy male neonate was born. His APGAR scores were 9 and 10 at 1 and 5 minutes, respectively. Five months later, the infant was healthy and his pediatric progress had been uneventful. Discussion: It was difficult to find information about the possible congenital defects related to the use of 3,4-DAP because it is a rarely used drug. This case attracted our interest because it is an uncommon disease, and we found no reports on the use of 3,4-DAP during pregnancy. To our knowledge, as of this writing, this is the first published report of the use of 3,4-DAP during pregnancy. Conclusions: A successful pregnancy with a healthy infant was achieved after fetal exposure to 3,4-DAP and pyridostigmine.

To assess the teratogenic risk associated with leflunomide during the first quarter of pregnancy, and to establish guidelines to minimize said risk.Literature search using tertiary, secondary, and primary sources related to teratogenicity, including databases (MEDLINE and EMBASE) and specific webs. The information required for assessment, as well as for the establishment of criteria was collected.Leflunomide demonstrated an increased risk of fetal death and teratogenic effects in animals. No major or minor malformation cases have been reported in humans regarding leflunomide, which is classified within category X of fetal risk. A wash-out regimen may possibly reduce the risk for fetal harm.Conception scheduling or early pregnancy detection is required for better clinical counselling and the avoidance of unnecessary risk.