Cases Of Embryopathy Research Articles

Continued use of Warfarin in lower dose has safe maternal and neonatal outcomes in pregnant women with Prosthetic Heart Valves.

Background and Objective:There has been concerns regarding the safety of Warfarin in pregnant females due to its teratogenic potential. At the same time warfarin provides best anticoagulation in patients with prosthetic valves. Various dosage regimes have been tried to strike a balance between safety of mother and the avoidance of congenital anomalies in the newborn. This study was conducted to observe the effect of Warfarin in pregnant mothers taking different doses of warfarin, and their neonatal outcome, in our outdoor patients.Methods:This is a cross sectional observational study conducted at the Faisalabad Institute of Cardiology. The pregnant mothers taking warfarin for prosthetic valve replacement who presented to our specialized clinic between November 2016 to April 2017 were included in the study. These included a total of 75 females between the age of 20-35 years. To compare the dose related effect of warfarin, two groups of the patients were formed. One group comprised of patients taking warfarin ≤5mg while the other group consisted of those who were taking >5mg of warfarin daily. These patients were followed till their delivery. The information was collected about the maternal and fetal outcomes. The maternal outcomes including mode of delivery/miscarriage, peripartum bleeding and any valve related thromboembolic complications. The fetal outcomes included birth weight, maturity, embryopathy and congenital anomaly in the baby.Results:Patient’s mean age was 29.25±3.75 years. The mitral valve replacement was present in 60% patients (n=45) while 25.3% patients (n=19) had aortic valve replacement and 14.7% patients (n=11) had double valve replacement. In this group 30 patients (40%) had taken <5 mg warfarin and 45 patients (60%) had received >5 mg warfarin medicine. Miscarriages, cesarean sections, low birth weight and prematurity were more common in patients receiving warfarin >5 mg with p-values 0.005, 0.046, 0.01 and 0.033 respectively. No case of fetal embryopathy was found in both groups.Conclusion:No case of embryopathy was found in each group which signifies that warfarin in lower doses is safe anticoagulant in patients with prosthetic valve replacements.

The organization, weaknesses, and challenges of the control of thalidomide in Brazil: A review.

The drug thalidomide has resurged in the world market under restrictive conditions for marketing and use. In Brazil, there are still cases of pregnant women using thalidomide even after the implementation of laws that regulate the control of use (Law No. 10.651/2003 and Collegiate Board Resolution No. 11/2011). The objective of this study was to discuss the control of thalidomide use in Brazil, based on a scoping review of the scientific literature, documents, and data from the Ministry of Health. A total of 51 studies and documents related to the following subthemes were selected: (1) organization of access and use of thalidomide in the health system; (2) epidemiological and population characteristics of people affected by leprosy; and (3) occurrence of pregnancy and cases of embryopathy with the use of thalidomide. The results showed that Brazil has no unified information database about thalidomide patients. Furthermore, there is inconsistency in the accreditation of public health centers that dispense this medicine, in a country that has a high consumption of thalidomide in the Unified Health System. A large part of this amount of dispensed medicine is intended for the treatment of erythema nodosum leprosum, mainly in the North, Northeast, and Central-West regions of the country, which are endemic for leprosy. This disease is the only one among the clinical indications of the medicine approved in Brazil that does not have a Clinical Protocol and Therapeutic Guidelines. The control of thalidomide use in Brazil presents historical regulatory failures. These are currently linked to the organization and structure of primary healthcare in the country, as well as to the lack of leadership of the Ministry of Health and National Health Surveillance Agency when it comes to managing the process of control of this use.

Oral anticoagulation throughout pregnancy in patients with mechanical heart valve prosthesis: Safe alternatives

Small dose of Warfarin (⩽5 mg/day) was suggested as being safe in pregnant patients with mechanical heart valve prosthesis (MHVP) however; no other oral anticoagulant (OA) alternative has been proposed to cases failing to achieve their target INR. We aimed to suggest the alternative use/shift of those cases to our previously reported safe (OA) Phenindione (⩽100 mg/day) and to compare both regimens. Eighty-seven females with 106 bileaflet MHVP implanted in the aortic (10; 11.5%), mitral (58; 66.7%) or both positions (19; 21.8%) continued OA throughout pregnancy, with restriction of daily doses to 5 mg Warfarin or 100 mg Phenindione. Patients were allowed to cross over if failed to achieve their target INR: 2-3.5. Aspirin (100 mg/day) was supplemented, starting second trimester. Out of 59 patients initially receiving Warfarin, 15 (25.4%) shifted to Phenindione, compared to none of 28 patients originally receiving Phenindione (P = 0.002). Mean INR and daily OA dose for 44 patients remaining on Warfarin and 43 patients receiving Phenindione were: 2.39 ± 0.34 versus 2.25 ± 0.2 (P > 0.05) and 3.9 ± 1.07 mg versus 79.3 ± 18.5 mg; respectively. Maternal complications were six cases of resolved vaginal bleeding (6.9%). There were no cases of embryopathy or prematurity. Fetal outcomes included 68 live births (78.2%), seven abortions (8%), two fetal loss (2.3%); all insignificantly related to OA dose or INR level. Although ⩽5 mg Warfarin per day can be safe during pregnancy, yet it cannot always achieve the target INR and ⩽100 mg of Phenindione can be considered as a comparatively safe alternative.

Birth defects observed with maternal carbimazole treatment: Six cases reported to Nice's Pharmacovigilance Center

Goals To report cases of embryopathy occurring following first trimester exposure to anti-thyroid drugs. Methods Retrospective screening of the database of our Pharmacovigilance Center from 1987 to date. Results We report six cases of embryopathy, all following carbimazole exposure during the first trimester: two cases of abdominal wall defect, including one associated with facial dysmorphia; one case of digestive malformation (patent omphalomesenteric duct); two cases of aplasia cutis including one with facial dysmorphism; one case of bilateral choanal atresia with aorta coarctation associated with poorly controlled insulin dependent diabetes. Four out of five patients were euthyroid with treatment during the first trimester. We found a context suggesting genetic predisposition to congenital malformation in three cases: two cases of parental cleft lip/palate, one case of consanguinity. Outcome was favorable in all cases. Conclusions We want to raise awareness about the potential teratogenicity of carbimazole, probably on a predisposed genetic background. We suggest better reporting of congenital anomalies in children of women with Graves’disease, with or without in utero exposure to anti-thyroid drugs. In light of current literature, propylthiouracil should be the first line treatment for hyperthyroid women wishing a pregnancy.

BIRTH DEFECTS LINKED TO AN ACNE TREATMENT.

Four cases of embryopathy associated with the use of isotretinoin during the first trimester of pregnancy were reported from New Jersey between 1983 and 1987. As …