look Pirfenidone Pregnancy and Breastfeeding Warnings Pirfenidone is also known as: Esbriet Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Compare Alternatives Pirfenidone Pregnancy Warnings Use should be avoided unless the benefit outweighs the risk. US FDA pregnancy category: C Fertility and embryo-fetal development studies revealed no evidence of impaired fertility or fetal harm in rats and rabbits that received oral doses up to 3 and 2 times, respectively, the maximum recommended daily dose (MRDD) in adults. However, a pre- and post-natal development study showed gestation prolongation, decreased number of live newborns, reduction in fetal viability and lower body weights in rats receiving an oral dosage approximately 3 times the MRDD in adults. Additionally, acyclic/irregular cycles were seen in rats at doses approximately equal to and higher that the MRDD in adults in the presence of maternal toxicity. There are no controlled data in human pregnancy. 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. See references Pirfenidone Breastfeeding Warnings 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: Yes 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 "Product Information. Esbriet (pirfenidone)." Intermune Inc, Brisbane, CA. References for breastfeeding information "Product Information. Esbriet (pirfenidone)." Intermune Inc, Brisbane, CA. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 Print this page See Also... pirfenidone 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 Pirfenidone Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Miscellaneous uncategorized agents Related Questions & Answers What is the difference between ofev, nintedanib, esbriet & pirfenidone? Read more questions most beneficial
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