THE Therapeutic Goods Administration has advised health professionals that the Product Information for nifedipine has been updated to provide new information about the risk of acute pulmonary oedema, when used for the treatment of preterm labour in pregnancy.
Nifedipine, marketed under several brand names including Adalat, Adefin, Addos and APO-Nifedipine, is indicated for the management of chronic stable angina pectoris and vasospastic angina pectoris due to coronary heart disease, as well as for the treatment of hypertension.
However the TGA has confirmed the receipt of four adverse event reports relating to off-label use in pregnancy, as a tocolytic agent (inhibiting myometrial smooth muscle contractions).
The relevant section of the PI has been updated to reflect the risk of oedema for intravenous pregnancy use, especially in cases of multiple pregnancy.
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