premiere Miglustat Pregnancy and Breastfeeding Warnings Miglustat is also known as: Zavesca Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Miglustat Pregnancy Warnings Animal studies have revealed evidence of fetal harm. This drug is expected to cross the placenta and has been shown to be embryotoxic in rats and rabbits. Women with type 1 Gaucher disease are at an increased risk of spontaneous abortion especially if disease symptoms are not treated and controlled before conception; disease symptoms may worsen or new symptoms may develop during pregnancy and such symptoms may lead to adverse pregnancy outcomes. There are no controlled data in human pregnancy. Studies in rats have shown this drug adversely affects sperm parameters, specifically motility and morphology. No effect on sperm concentration, motility, or morphology was observed in 7 healthy men taking 100 mg twice a day for 6 weeks. Until further data is available, male patients should consider stopping this drug before seeking to conceive and using effective contraceptive methods while taking this drug and for 3 months thereafter. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. 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. Use is not recommended unless the benefit outweighs risk to the fetus AU TGA pregnancy category: D US FDA pregnancy category: C Comment: Effective contraceptive measures should be encouraged for both males and women of childbearing potential. See references Miglustat Breastfeeding Warnings Use is not recommended and 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: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown. See references References for pregnancy information Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 Cerner Multum, Inc. "Australian Product Information." O 0 "Product Information. Zavesca (miglustat)." Acetelion Pharmaceuticals US, Inc, South San Francisco, CA. References for breastfeeding information Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 Cerner Multum, Inc. "Australian Product Information." O 0 "Product Information. Zavesca (miglustat)." Acetelion Pharmaceuticals US, Inc, South San Francisco, CA. Print this page See Also... miglustat Consumer Information Pregnancy Support Group FDA Pregnancy Categories Medicine use during Pregnancy Medicine use while Breastfeeding Safe Medications during Breastfeeding 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. Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Miglustat Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Miscellaneous metabolic agents Help and Support Looking for answers? Ask a question or go join the miglustat support group to connect with others who have similar interests. customise
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