Global pharmaceutical company Sucampo has received a supplement approval from the US Food and Drug Administration (FDA) for updates to AMITIZA (lubiprostone) pregnancy labeling.
The approval removes pregnancy ‘warnings and precautions’ and clarifies information regarding the use of AMITIZA by pregnant and/or nursing women.
Besides, the FDA expanded the labeling text of the ‘Mechanism of Action’ section in the prescribing information for AMITIZA, which is approved for the treatment of chronic idiopathic constipation (CIC) in adults and irritable bowel syndrome with constipation (IBS-C) in women with 18 years of age and older.
The new labeling changes will allow physicians and women of child-bearing age who are suffering from IBS-C or CIC to better analyse the risk-benefit profile of Amitiza.
All warnings and precautions related to pregnancy have been removed under the new labeling changes. It includes removal of the sentence ‘Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.’
‘Use in Specific Populations,’ was modified to include additional animal data and a clinical consideration section, retaining the pregnancy category as it is.
The revised label with regard to the potential for serious adverse reactions in nursing infants, states that caution should be exercised when AMITIZA is administered to a nursing mother. It also advises ‘lactating women to monitor their human milk-fed infants for diarrhea while taking AMITIZA.’