Milnacipran Pregnancy and Breastfeeding Warnings
Milnacipran is also known as: Savella
Milnacipran Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: C
Animal studies have revealed evidence of minor skeletal variation, embryo fetal, and perinatal lethality. There are no adequate or well-controlled studies in pregnant women. Neonates exposed to SSRIs and 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 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. To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Healthcare providers are advised to recommend that pregnant patients taking Savella(R) enroll in the pregnancy registry. Enrolment is voluntary and may be initiated by pregnant patients or their healthcare providers by contacting the registry at 1-877-643-3010 or by email at email@example.com. Data forms may also be downloaded from the registry website at www.savellapregnancyregistry.com. 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.
Milnacipran Breastfeeding Warnings
Caution is recommended. 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.