Pregnancy of Quinoctal in details
Quinoctal has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Congenital abnormalities (including damage to the auditory and optic nerve) have been reported following the use of large doses of Quinoctal for its abortifacient effect. Quinoctal is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
Quinoctal crosses the placenta and gives measurable blood concentrations in the fetus. In 8 women who delivered live infants 1 to 6 days after starting Quinoctal therapy, placental cord plasma Quinoctal levels were between 1.0 and 4.6 mg/L and the ratio of cord plasma to maternal plasma Quinoctal levels averaged 0.32. During a study of women with Plasmodium falciparum malaria, difference in the rate of stillbirths at greater than 28 weeks of gestation was not significant in pregnant women treated with Quinoctal compared to a control group without malaria or exposure to antimalarial agents during pregnancy. The overall rate of congenital malformations was not different for women treated with Quinoctal (1.4%) compared with the control group (1.7%). The rate of spontaneous abortion was lower in women treated with Quinoctal (3.5%) than in the control group (10.9%). In an epidemiologic survey, risk of structural birth defects was not increased in 104 mother-child pairs exposed to Quinoctal during the first 4 months of pregnancy. Two fetal malformations (1.9%) were reported. Teratogenic effects were observed in 21 infants exposed to Quinoctal during the first trimester following unsuccessful abortion attempts. These effects included central nervous system, digestive organ, urogenital, and vertebral anomalies; limb, facial, and heart defects; and hernias. Neonatal and maternal thrombocytopenia purpura and hemolysis in glucose-6-phosphate dehydrogenase-deficient newborns have been reported with Quinoctal use. The Michigan Medicaid Birth Defects Study included 35 newborns exposed to Quinoctal during the first trimester. Two (5.7%) major birth defects were observed; 1 was expected. There were no observations of cardiovascular defects, cleft palate, spina bifida, polydactyly, limb reduction, or hypospadias. Briggs, et al has assigned Risk Factor D to Quinoctal. Although increased teratogenic risk has not been proven, avoiding Quinoctal use during pregnancy has been recommended. A manufacturer of a formerly available Quinoctal product considered it contraindicated in pregnancy. There is no evidence that Quinoctal causes uterine contractions at the doses recommended to treat malaria. In doses several times higher than those used to treat malaria, Quinoctal may stimulate the pregnant uterus.
See references
Quinoctal breastfeeding
Quinoctal is excreted into human milk in small amounts. Adverse effects in the nursing infant are unlikely, but the diagnosis of glucose-6-phosphate dehydrogenase deficiency should be ruled out before breast-feeding. Quinoctal is considered compatible with breast-feeding by the American Academy of Pediatrics.
See references
References for pregnancy information
- "Multum Information Services, Inc. Expert Review Panel"
- Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 7th ed." Philadelphia, PA: Lippincott Williams & Wilkins (2005):
- "Product Information. Qualaquin (Quinoctal)." AR Scientific Inc, Philadelphia, PA.
References for breastfeeding information
- "Product Information. Qualaquin (Quinoctal)." AR Scientific Inc, Philadelphia, PA.
- "Multum Information Services, Inc. Expert Review Panel"
References
- DailyMed. "QUININE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubMed Health. "Quinine (By mouth) (Qualaquin): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
- Human Metabolome Database (HMDB). "Quinine: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
