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NEWS

Manufacturers' Alerts

This page contains information that SHPA has received from manufacturers of medicines, such as alerts regarding supply problems, discontinued items etc. that may be useful to SHPA members.

  • Updated Consensus Guidelines for Australian Clinicians for the usage of anticoagulants during heparin-based product shortages - August 2008
    The Department of Health and Ageing consensus guidelines that were released in May 2008 in response to the recall of Clexane (enoxaparin) and subsequent shortage of alternative anticoagulants have been updated. Click here for the updated consensus guidelines.

  • Discontinuation of AstraZeneca's heparinised saline - August 2008
    AstraZeneca have announced the discontinuation of Heparinised Saline (Porcine) Heparin Sodium 50 IU/5 mL Injection Ampoule. More...

  • Heparin and Fragmin (dalteparin) supply - May 2008
    Due to the recent recall of enoxaparin, worldwide demand for Fragmin (dalteparin) has significantly exceeded forecasts and it is unknown when supply will return to normal. Pfizer Australia is collaborating with the TGA to manage the limited supply of Fragmin (dalteparin). More information is available in this letter from Pfizer.

  • Clexane (enoxaparin) - May 2008
    Following a request from the Therapeutic Goods Administration (TGA), sanofi-aventis is undertaking a two-staged recall process involving five affected batches of Clexane (enoxaparin), with Stage 1 being a quarantine of stock, with no stock return. The quarantine is being implemented as a precautionary measure due to the presence of low levels of an impurity in pure heparin associated with anaphylactic reactions in the US and Germany. This impurity is a worldwide heparin issue affecting a number of heparin products globally, not just Clexane (enoxaparin).
    For more information read this initial recall information from sanofi-aventis and this recall update.

  • Zolpidem - March 2008
    Sanofi-aventis informs that the Therapeutic Goods Administration (TGA) has requested that all sponsors of zolpidem introduce a boxed warning to further reinforce important information that exists in the Product Information (PI) and Consumer Medicine Information (CMI) related to the appropriate use of this medicine. For more information, see the letter from Sanofi-aventis.

  • Discontinuation of Aerodiol (oestradiol) nasal spray - 2 November 2007
    Servier is discontinuing the manufacture of Aerodiol nasal spray worldwide, including Australia. There will be sufficient stock of the product until 31 January 2008 and Aerodiol will remain on the PBS until 1 April 2008. For any specific questions about the discontinuation of Aerodiol please phone Servier on 1800 153 590.

  • Update to product information for Rosiglitazone-Containing Products - November 2007
    GSK is updating the product information documents of Avandia (rosiglitazone maleate) and Avandamet (rosiglitazone maleate and metformin hydrochloride) with precautionary statements, including a boxed warning ,relating to rosiglitazone use and myocardial ischaemia seen in certain patient groups. For more information see letter,   Avandia product information,   Avandamet product information

  • Hysone supply in Australia - November 2007
    Alphapharm are the sole suppliers of hydrocortisone tablets in Australia. These tablets are sold as HYSONE 4 mg or 20 mg tablets. As you may be aware, many pharmacies are currently out of stock of HYSONE tablets. This problem has arisen due to the discontinuation of the low moisture starch sourced for use in the production of HYSONE. As a result, many patients may not be unable to have their prescriptions dispensed over the coming weeks. We sincerely apologise for this unavoidable situation. Whilst our manufacturing team continues to analyse acceptable alternative formulations, we are not yet in a position to recommence commercial manufacture although we believe that we may be in a position to do so by mid-late November. In the meantime, we are pursuing the following strategies to ensure that patients who are short of HYSONE tablets can continue to receive essential supply: 1. We have a very small reserve stock of 20 mg tablets, and a slightly larger reserve of 4 mg tablets, which we are distributing on an individual patient basis following discussions with the prescriber. We would appreciate the assistance of members of the Endocrine Society in working with us to ensure that only patients genuinely short of tablets, and likely to run out before mid November, receive this reserve stock. 2. We are currently arranging for the importation of hydrocortisone 20 mg tablets from the United Kingdom. Pending regulatory clearance we anticipate these tablets will be available for supply towards the middle of November. 3. We have submitted a reformulated 4 mg HYSONE tablet for registration by the TGA. We are hopeful of a positive response from the TGA evaluators shortly. We suggest that reserve stock is only supplied on the advise of either the endocrinologist or general practitioner managing the patient, after contacting Alphapharm Medical Affairs on 02 9298 3965.

  • Discontinuation of Zovirax (acyclovir) 250 mg and 500 mg powder for injection - September 2007
    GlaxoSmithKlineAustralia (GSKA) wishes to inform pharmacists that Zovirax (acyclovir) 250 mg and 500 mg powder for injection has been discontinued due to the low demand and the presence of direct alternatives on the market. However, the supply of all other Zovirax (acyclovir) preparations is not affected.
    If you have any questions, please contact GSKA Medical Information Department on 1800 033 109.

  • Discontinuation of Pronestyl Injection 1 g/10 mL (procainamide hydrochloride) - August 2007
    In March we informed you that Bristol-Myers Squibb (BMS) would discontinue the supply of Pronestyl Injection 1 g/10 mL (procainamide hydrochloride), with supply available until the end of 2007. However, due to unforeseen complications with manufacturing we regret to advise you of the immediate discontinuation globally of Pronestyl Injection 1 g/10 mL. There is currently no stock of Pronestyl Injection available and our suppliers will not manufacture any further batches of the product.
    If you have any questions, please contact our Medical Information Department on 1800 067 567.

  • Apomorphine HCl (APO-go) Solution for injection 20 mg/2 mL - product recall - August 2007
    After consultation with the Therapeutic Goods Administration, Mayne Pharma Limited is conducting a company sponsored recall of two batches, Z006 and Z007 of Apomorphine Hydrochloride (APO-go) Injection 20 mg/2 mL. For more information see product recall letter,   medicine recall letter,  fax reply form

  • Bristol-Myers Squibb Pharmaceuticals - Diclocil, Florinef, Iscover and Pronestyl Product News - 2 March 2007

    15/2/2007: Dr Paul Slade, Medical Director, Bristol-Myers Squibb Pharmaceuticals, has advised of changed packaging for Iscover, stock availablility problems for Diclocil, changes to Florinef tablets, and the deletion of Pronestyl. For more more information see the letter from Dr Slade .

    Florinef (fludrocortisone acetate) Revised Storage Conditions - 19 January 2007

    8/11/2006: Bristol-Myers Squibb Pharmaceuticals have advised of new storage conditions for Florinef. See the letter from Marian Gandy, Associate Director, Medical Affairs, Bristol-Myers Squibb for further information.

  • Perfalgan (IV paracetamol) Rubber Bungs - 17 November 2006

    8/11/2006: Bristol-Myers Squibb Pharmaceuticals have advised of compliance of Perfalgan rubber bungs and provided recommendations for piercing the bung. See the letter from Heath Merlo, Associate Product Manager, Bristol-Myers Squibb for further information.

  • Possible glass fragments in 30 mL amber glass bottles - 9 November 2006

    31/10/2006: Sigma Pharmaceuticals Ltd has advised of infrequent defects in some 30 mL amber glass bottles containing tablets, with some isolated instances of bottle moulding defects. In some cases, easily identifiable amber glass fragments have been found in bottles. See the letter from Sigma Pharmaceuticals for further information.

  • Donepezil (Aricept) - safety update - May 2006
    This letter from Pfizer outlines that the Precautions section of the Approved Product Information for Aricept (donepezil hydrochloride) has been updated with safety results from three studies of Aricept in vascular dementia.

  • Quinidine bisulphate (Kinidin) Durules discontinuation - May 2006
    AstraZeneca announces in this letter the impending discontinuation of quinidine bisulphate (Kinidin) Durules.

  • Glucose 5% deletion - March 2006
    AstraZeneca announces that they have deleted Glucose Injection BP 5% 100 mL single dose glass vial. Read this letter for more information.

  • Potassium Chloride Injection - February 2006
    AstraZeneca advises in this letter that the products listed below have been deleted, effective immediately. The decision to rationalise the potassium chloride range was taken in part to increase the safety of potassium chloride administration by removing high-dose ampoules from the hospital system.
  • Potassium Chloride Injection 1 g (13.4 mmol) in 10 mL
  • Potassium Chloride Injection 2 g (26.8 mmol) in 10 mL

  • Isordil (isosorbide dinitrate) 20 mg Tablets - August 2005
    Read the letter from Sigma Pharmaceuticals about the discontinuation of Isordil 20 mg Tablets. Isordil 20 mg Tablets will be deleted from the PBS book as of 1 December 2005. Isordil 5 mg and 10 mg Tablets will continue to be supplied by Sigma.

  • Oroxine & Eutroxsig (thyroxine) Tablets - August 2005
    Read the letter from Sigma Pharmaceuticals about changes to the pack sizes of Oroxine and Eutroxsig tablets. This letter outlines the new packaging of these into 5 bottles of 40 tablets, replacing the current pack size of 200 tablets. The new packaging allows the bottle of tablets in use to be stored at room temperature while the remaining unopened bottles are refrigerated.




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