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What Risk Category Methadone?

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Nehmo Sergheyev

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Mar 11, 2001, 8:02:43 AM3/11/01
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What is the correct FDA pregnancy risk category for methadone?

This site gives B-D

http://www.perinatology.com/exposures/druglist2.htm#Methadone
Methadone
CATEGORY:B,D
All narcotics may produce withdrawal syndrome in neonates with prolonged use
BREAST FEEDING:With caution
NEONATAL SIDE EFFECTS:Sedation,withdrawal (limit to <20mg/d )

We get a C here
Clinical Pharmacology 2000
http://cp.gsm.com/ (register and search for methadone)
Contraindications [section]
Methadone is classified as pregnancy category C. This risk factor increases
to pregnancy category D if used for prolonged periods or in high doses close
to term. The risks versus benefits of methadone for the treatment of pain in
pregnant women should be carefully considered. Maternal methadone
maintenance is recommended for pregnant, opiate-dependent women.

The current labeling information from Mallinckrodt
http://www.mallinckrodt.com/ , a methadone manufacturer, states no pregnancy
category.

What's the correct category?

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