Safety Information

Revised: 25 September 2018

Dear Healthcare Professional Letters

This section provides copies of letters sent to healthcare professionals by the therapeutic products industry. These letters detail possible safety or quality concerns, they are published here on behalf of the industry. These letters are provided voluntarily and this section may not be comprehensive.

Date sent Product Reason
27 September Coaguchek (PDF 559 KB, 8 pages) Roche reconfirms their recommendation that Coaguchek INR results above 4.5, from lots specified in the attached notification, are confirmed with a laboratory method.
25 September 2018 Volulyte and Voluven (PDF 821 KB, 2 pages) Safety information update
20 August 2018 Dilantin (PDF 209 KB, 2 Pages) Clarification regarding Dilantin Dear Healthcare Professional Letter dated 19 July 2018
13 August 2018 Bicillin (PDF 1,135 KB, 4 Pages) Changes to expression of product strength
6 August 2018 Tivicay (PDF 87 KB, 3 Pages) Tivicay (dolutegravir): neural tube defects reported in Tsepamo Study, Botswana
19 July 2018 Dilantin (PDF 91 KB, 2 Pages) Dissolution profile of Dilantin® 30 mg and 100 mg capsules (New Formulation)
3 July 2018 Neulactil (PDF 78 KB, 2 pages) Provisional Consent of Neulactil periciazine 2.5mg and 10mg tablets (Hong Kong stock) to cover temporary stock shortage
5 December 2017 Ofev (PDF 1052 KB, 2 pages) Information on severe liver injury in patients with idiopathic pulmonary fibrosis
3 August 2017 Tecentriq (PDF 70 KB, 2 pages) Severe cases of myocarditis
27 March 2017 Zelboraf (PDF 98KB, 2 pages) Risk of Dupuytren's Contracture and Plantar Fascial Fibromatosis
14 December 2016 Erivedge (PDF 110 KB, 2 pages) Extension of Pregnancy Prevention Duration for Women of Childbearing Potential and Interval before Blood Donation and Lactation
15 August 2016 Noxafil (PDF 212 KB, 2 pages) Posaconazole tablets and oral suspension are not interchangeable
2 June 2016 Erivedge (PDF 111 KB, 2 pages) Risk of premature epiphyseal fusion
24 May 2016 Invokana (PDF 71 KB, 2 pages) Advice on the risk of lower limb amputations primarily of the toe during treatment with canagliflozin
8 December 2015 Cellcept (PDF 100 KB, 3 pages) New restrictions on use due to teratogenic risk
1 December 2015 Tarceva (PDF 91 KB, 2 pages) Indication restricted to EGFR-activating mutations only
9 July 2015 Forxiga (PDF 28 KB, 2 pages) Risk of ketoacidosis
29 April 2015 Motilium (PDF 344 KB, 1 page) New recommendations to minimise cardiac risks
8 December 2014 Reminyl (PDF 669 KB, 1 page) Serious skin reactions
26 November 2014 Dilatrend tablets (PDF 335 KB, 2 pages) Severe cutaneous adverse reactions
5 August 2014 Cal.D. Forte tablets (PDF 310 KB, 1 page) Update on stability issues
5 August 2014 Topamax tablets (PDF 142 KB, 1 page) Additional warnings and precautions - Visual field defects
4 August 2014 Concerta tablets (PDF 181 KB, 1 page) Additional precaution - Priapism
1 July 2014 Bacillus Calmette-Guerin (BCG) vaccine (PDF 304 KB, 2 pages) Supply of unapproved medicine under S29 of the Medicines Act
20 May 2014 Piportil depot Injection (PDF 34 KB, 1 page) Update to supply issues
17 January 2003 Traditional Chinese Medicines Products containing toxic substances and prescription medicines