APRESOLINE hydralazine hydrochloride 20mg powder for injection - medicine shortage

Medicine shortage

16 January 2015

Health professionals are advised that Link Pharmaceuticals (Link) has submitted a Medicine shortage notification for APRESOLINE hydralazine hydrochloride 20mg powder for injection (AUST R 43190). The shortage is due to supply disruption and there are no safety concerns with existing supplies.

The shortage is expected to be resolved by March 2015.

APRESOLINE hydralazine hydrochloride 20mg powder for injection is used to treat hypertensive emergencies. For severe hypertension, in general, there are alternative registered products.

In cases of hypertensive emergencies in pregnancy an alternative treatment is intravenous labetalol which is currently available to obstetricians and gynaecologists through the Special Access Scheme.

Information for obstetricians and gynaecologists

Link is in the process of contacting Australian obstetricians and gynaecologists, intensive care specialists and hospital pharmacies to inform them of the medicine shortage.

Guidelines for the management of hypertension in pregnancy have been developed by the Society of Obstetric Medicine of Australia and New Zealand and are available from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) website. Health professionals are referred to these guidelines for further information.

Labetalol injection is not currently authorised for supply in Australia. Labetalol injection is available through the Special Access Scheme.

The TGA is working with sponsors to arrange alternative supply of hydralazine which health professionals can access for individual patients through the Special Access Scheme.

Information for pregnant women

APRESOLINE hydralazine hydrochloride 20mg powder for injection is only used to treat severe hypertension in pregnancy. Alternative medicines are available if you are experiencing mild to moderate hypertension in pregnancy. Please see your doctor if you have any concerns.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines, vaccines or medical devices. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse events associated with a medicine, vaccine or medical device.