Fluvoxamine Pregnancy and Breastfeeding Warnings
Fluvoxamine Pregnancy Warnings
Animal studies have revealed evidence of embryofetal toxicity. Additionally, these studies, have shown that this drug may affect sperm quality. Human case reports from some Selective Serotonin Reuptake Inhibitors (SSRIs) have shown this effect to be reversible. The impact of this on human fertility has not been observed. There are no controlled data in human pregnancy. Neonates exposed to SSRIs and Serotonin-Norepinephrine Reuptake Inhibitor (SNRIs) late in the third trimester have uncommonly reported clinical findings including respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These effects have mostly occurred either at birth or within a few days of birth. These features are consistent with either a direct toxic effect of SSRIs and SNRIs, or possibly a drug discontinuation syndrome. In some cases, the clinical picture is consistent with serotonin syndrome. Epidemiological data have suggested that the use of SSRIs, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn. Data are not available for SNRIs. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA Pregnancy Category: C US FDA Pregnancy Category: C Comments: -Newborns should be monitored if the maternal use of this drug continues into the later stages of pregnancy, particularly the third trimester. -Abrupt discontinuation should be avoided during pregnancy.
Fluvoxamine Breastfeeding Warnings
AU, UK: Use should be avoided. US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.