BLOOMS RASPBERRY LEAF 2000 (Phytologic Holdings Pty Limited)
Product Name
BLOOMS RASPBERRY LEAF 2000
Sponsor
Date of review outcome
Date of publication
Jun-22
Outcome
Medicine continues to be permitted for supply. Batches released from 15 March 2022 must carry a corrected label.
Is it safe to continue using this medicine?
Yes, however use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
If you are pregnant, consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to relieving morning sickness and enhancing uterine health. Be aware that the medicine should not be used during the first or second trimester of pregnancy and the claim about helping prepare the body for labour only applies to the third trimester of pregnancy. Seek advice from your doctor if you have been taking the medicine during the first or second trimester of pregnancy.
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
The sponsor did not hold sufficient evidence to support the safety of the medicine when used during the first or second trimester of pregnancy. The limitations with the evidence included that the dosage, stage of pregnancy and duration of treatment with the ingredient Rubus idaeus (red raspberry leaf) were inconsistent with the medicine. However, the label warns that pregnant women should advise their doctor of any medicine taken, particularly in their first trimester. As such, the medicine is unlikely to pose an immediate risk to pregnant women.
Issues related to efficacy
None
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor removed the claims 'relieve morning sickness’ and 'uterine tonic/ enhance uterine health’ from the label, website and/or ARTG record. The sponsor also updated the label and website to include the statements 'Not for use during the first or second trimester of pregnancy’ and 'When used during the last trimester of pregnancy … to help prepare the body for labour’.