This information is presented for the use of health professionals prescribing medicines to pregnant women, rather than for the general public to use. It is general in nature and is not presented as medical advice to health professionals or the public. History of chloroquine Plaquenil adverse effect on retina PLAQUENIL hydroxychloroquine sulfate tablets contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Usage in Pregnancy—Usage of this drug during pregnancy should be avoided except in US FDA pregnancy category Not Assigned The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of. Given these reports in animals, it is considered a category X medication for pregnancy Table 1. The drug has a long half-life of 14–15 days but also undergoes enterohepatic circulation as a result of which it may take up to 2 years for complete elimination from the body after discontinuation Temprano et al. 2005. The pregnancy categorisation system only applies to recommended therapeutic doses in women. It is not intended to be used as a substitute for a health professional's advice. The categorisation system has taken into account the known harmful effects of medicines on the developing baby, including the potential to cause: The categorisation system does not take into account the rare circumstance of an idiosyncratic reaction in the neonate to a medicine that crosses the placenta. Plaquenil fda pregnancy category Plaquenil Hydroxychloroquine - Side Effects, Dosage., Hydroxychloroquine Use During Pregnancy Acr plaquenilPlaquenil contraindicationsSkin changes with plaquenil FDA classification system for drug safety during pregnancy. The FDA classification system for the safety of drugs during pregnancy categorizes drugs from A to D and X, based on evidence from studies conducted in animals and humans, where A is no evidence of risk to the human fetus, D some evidence risk to the human fetus, and X is a high level. Drug Safety in Pregnant & Nursing Women.. Use of DMARDs and biologics during pregnancy and lactation.. Hydroxychloroquine use while Breastfeeding. The recommended dose of hydroxychloroquine Plaquenil in adults is 400 mg on exactly the same day of each week. The recommended weekly suppressive dose of hydroxychloroquine Plaquenil in children 6 years of age and older is 5 mg base/kg. This dose should not exceed the adult dose reg ardless of body weight. Women with rheumatic diseases, including inflammatory arthritis and systemic lupus erythematosus SLE, fare better in pregnancy when their disease is under good control1,2. The role of hydroxychloroquine HCQ for achieving this control is now recognized. Several studies demonstrate that patients with SLE who continue HCQ during pregnancy have decreased flares and improved pregnancy outcomes. FDA Pregnancy Categories Category A. Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy and there is no evidence of risk in later trimesters. Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled.