Risk of acute pulmonary oedema with Nifedipine when used for the treatment of preterm labor in pregnancy: Product label update from Therapeutic Goods & Administration (TGA) – Health authority of Australia.
The ‘Fertility, pregnancy and lactation’ section of the nifedipine PI (section 4.6) has been updated to include the following information:
‘Acute pulmonary oedema has been observed when calcium channel blockers, among others nifedipine (primarily in [immediate release] formulation), have been used as a tocolytic agent during pregnancy, especially in cases of multiple pregnancy (twins or more), with the intravenous route and/or concomitant use of beta-2 agonists.’
Nifedipine is a calcium channel blocker which acts by inhibiting myometrial smooth muscle contractions and it is used for the below indications.
- Chronic stable angina pectoris and vasospastic angina pectoris due to coronary heart disease
- Hypertension treatment
Important note for Healthcare professionals:
Awareness: Nifedipine is contraindicated in pregnancy and during lactation. However, the TGA has received four case reports involving off-label use of nifedipine in pregnancy.
Individual Benefit-risk ratio: It is recommended to consider nifedipine off-label use in pregnancy ONLY when alternative treatments are not available, exhausted, or not tolerated, unsuitable. Please discuss both the risk & benefits of using this medicine with patient during pregnancy and for close monitoring of adverse events.
Important note for Public (Patients/patient care providers):
Be aware of this potential risk for Nifedipine, and consider using alternative treatment options having favorable benefit-risk profile for use during pregnancy.
Inform your respective doctor or healthcare professional about your underlying medical conditions and concurrent use of other medications. This facilitates the effective assessment of benefit-risk ratio and identification of suitability of the medicine for use/or looking for alternative medicine with the favorable benefit risk ratio.
Be conscious of below signs and symptoms this potential risk and inform your respective healthcare professional or report to your national ADR reporting system.
Every medicinal product has both benefits and risks. Medicines are authorized to market based on the favorable benefit-risk profile anticipated at the time of regulatory approval/entry into market. However, the safety profile of medicine would continuously updates owing to safety data from the post marketing experience from public. If the rate of reporting of suspected adverse drug reactions (ADR) from public is line with the actual occurrence of ADRs, the time lapse for taking regulatory action can be reduced and thereby improving patient safety.
All health care professionals and consumers of pharmaceutical medicinal products are encouraged to be aware of this fact and observe/monitor for any possible adverse events, reactions, medication errors, or quality complaints of medicinal products and report the same to your respective national health authority.
This would accumulate safety evidence for medicinal products which in turn help health authorities to take regulatory actions at the earliest possibility for a better patient safety and overall public health.