Endocrine Pharma News

URGENT RECALL FOR PRODUCT CORRECTION: MiniMed 640G Insulin Infusion Pump
Medtronics is initiating a product recall of its MiniMed 640G insulin pumps. Please see the following link for details.
https://www.medtronic-diabetes.com.au/customer-support/safety-information
(Posted 16 February 2017)

TGA has announced that the duration of the shortage of clomiphene citrate has been extended (see attached link for details). https://www.tga.gov.au/alert/clomifene-clomiphene
(Posted 6 February 2017)

TGA have updated information regarding shortages of Avandamet, Carbimazole, ESTRADOT and Androderm on their website. See the following links for details. http://apps.tga.gov.au/prod/msi/Search/Details/Rosiglitazone-maleate

http://apps.tga.gov.au/prod/msi/Search/Details/Carbimazole

http://apps.tga.gov.au/prod/msi/Search/Details/estradiol

http://apps.tga.gov.au/prod/msi/Search/Details/Testosterone
(Posted 6 February 2017)

TGA have reported shortages of ESTALIS CONTINUOUS, ESTRADOT, ESTALIS SEQUI. Please see the following link for details: http://apps.tga.gov.au/prod/msi/Search/Details/estradiol
(Posted 18 November 2016)

AVANDIA
TGA have reported discontinuation of AVANDIA effective 31st January 2017. Please see the following link for details: http://apps.tga.gov.au/prod/msi/Search/Details/Rosiglitazone-maleate
(Posted 10 November 2016)

Carbimazole
Update on carbimazole availability: according to TGA website neomercazole is expected to be supplied from Nov 14 (updated 16 Oct), carbimazole link from 3 Jan (updated 29 Sep)
(Posted 28 October 2016)

TGA have reported a medication shortage for AVANDAMET.

Please see the following link for details: http://apps.tga.gov.au/prod/msi/Search/Details/Rosiglitazone-maleate

(Posted 21 October 2016)

Carbimazol Aristo approved for supply under S19A to address shortage

To address the shortage of Australian registered carbimazole 5mg tablets, Link has been grated TGA approval to supply German registered Carbimazol Aristo 5mg tablets, under S19A of the Therapeutic Goods Act.

Download the Dear Healthcare Professional letter for further information.

(Posted 7 October 2016)

 

Novo Nordisk Pharmaceuticals Pty Ltd is recalling certain batches of GlucaGen® HypoKit due to a small number of needles becoming detached from the pre-filled syringe supplied in the GlucaGen® HypoKit

Novo Nordisk Pharmaceuticals Pty Ltd is recalling 4 batches of GlucaGen® HypoKit in Australia. GlucaGen® HypoKit is used for the ‘treatment of severe hypoglycaemic reactions which may occur in the management of diabetic patients receiving insulin or oral hypoglycaemic agents’.

This action has been undertaken following consultation with the Therapeutic Goods Administration (TGA).

Novo Nordisk conducted an investigation showing a small number (0.006%) of needles from certain batches may become detached from the pre-filled syringe supplied, during use. Despite the very low risk to patient safety, Novo Nordisk is recalling all products in the affected batches from wholesalers, pharmacies and patients in Australia.

The recalled GlucaGen® HypoKit batch numbers and expiry date in Australia are:

Batch Number

Expiry date

FS6X465

31-Aug-2017

FS6X536

31-Aug-2017

FS6X715

31-Aug-2017

FS6X891

31-Aug-2017

Note that community and hospital pharmacies will also be contacted and requested to follow up with patients they have supplied since February 2016 and will be asked to return any stock they hold from affected batches. Formal notification has also been sent to mainstream national media, professional diabetes/endocrine societies, RACGP, RACP and diabetes patient associations.

We have attached a patient information leaflet you may find useful when explaining to patients the nature of the issue. You may wish to share this with patients.

If patients have a GlucaGen® HypoKit from an affected batch they are to return it to their pharmacy. They will be given a free replacement either immediately (if the pharmacy has unaffected stock available) or within a few days (if the pharmacy has to await resupply). If the pharmacy does not receive a replacement immediately, the patient is to retain their GlucaGen® HypoKit until the replacement can be provided, as the likelihood of a detached needle is very low.

Importantly, if you are in possession of GlucaGen® HypoKit products with batch numbers NOT mentioned above there is NO concern and you can be confident that the products will work as prescribed.

Further information

Posted (15/09/2016)

 

Clomid (clomiphene citrate) - Variation in supply

Sanofi would like to inform you of a temporary supply shortage of Australian approved Clomid, indicated for the treatment of ovulatory failure in carefully selected infertile women who wish to become pregnant1.

Download notification

(posted 12/07/16)

Important Notifcation regarding INVOKANA® (canagliflozin) Discontinuation and Cessation of Supply

Download notification

(posted 20/06/16)

 

Statement on Metformin

From a spokeswoman for the TGA:

The TGA is in contact with sponsors of metformin products to clarify the reported shortage issue.

Download statement

(posted 27/05/2016)

 

INVOKANA (canagliflozin) : Advice on the Risk of Lower Limb Amputation Primarliy of the Toe during treatment with canagliflozin

Download letter

(posted 27/05/2016)

 

Important update regarding discontinuation of Fosamax 40mg in Australia

Please Download the letter from MSD to inform the ESA of the decision to discontinue Fosamax 40mg in Australia.

(posted 7/4/2016)

 

INFORMATION: Access to TOUJEO® (insulin glargine 300 units/mL)

Sanofi, the manufacturer of Toujeo® (insulin glargine 300 units/mL), wish to update you regarding  access in Australia.

Download letter

(posted 19/05/2016)