Please see my post below to Lactnet on August 3, 2012:
Frank J. NiceEdit profile detailsFrom:Frank J. Nice ([log in to unmask])Sent:Fri 8/03/12 6:54 PMTo: LACTNET ([log in to unmask])
I just spoke for 1/2 hour with a representative from MedWatch regarding the new Methergine breastfeeding labeling.
I alerted MedWatch to both my and Tom Hale's recommendations and to Tom's website.
I explained the need for more breastfeeding pharmacokinetic and pharmacodynamic data and for a comprehensive breastfeeding and medication
benefit -risk analysis (see my article) to be included in labeling for breastfeeding and Methergine.
Evidently, the FDA has received many questions to date from the nursing and breastfeeding community regarding this new labeling.
It appears critical to continue to contact the FDA as individuals and organizations regarding this issue.
Thank you.
Frank J. Nice, RPh, DPA, CPHP
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