Revised: 25 September 2019
Safety Information
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 |
|---|---|---|
| 25 September 2019 | MMR II Vaccine (PDF 501 KB, 4 pages) | Additional supply of MMR II measles, mumps and rubella vaccine: differences in labelling and package inserts |
| 9 August 2019 | Femme-Tab (PDF 174 KB, 1 page) | In light of recent shortage of Combined Oral Contraceptive products, Microgynon® (Bayer) and Levlen® (Bayer) in New Zealand, Femme-Tab ED 20/100 (Ethinyloestradiol 20 mcg + Levonorgestrel 100 mcg) and Femme-Tab ED 30/150 (Ethinyloestradiol 30 mcg + Levonorgestrel 150 mcg) have been available from 17 July 2019 |
| 17 July 2019 | Ranbaxy-Cefaclor (PDF 222 KB , 1 page) | Supply disruption for Cefaclor oral suspension and Acarbose tablets: difference in reconstitution volume for Keflor granules |
| 3 July 2019 | FluQuadri (PDF 109 KB, 2 pages) | Additional supply of FluQuadri influenza vaccine: differences in labelling and package inserts |
| 13 June 2019 | Tecentriq (PDF 649 KB, 2 pages) | Notification of Immune-related Myositis as new Important Identified Risk for Tecentriq |
| 11 June 2019 | Xiaflex (PDF 231 KB, 2 pages | Xiaflex® (collagenase clostridium histolyticum) product discontinuation from 28 June 2019 |
| 7 May 2019 | Actemra (PDF 361 KB, 3 pages) | New important identified risk: Hepatoxicity |
| 26 March 2019 | Darzalex (PDF 103 KB, 2 pages) | New important identified risk: Hepatitis B Reactivation |
| 15 February 2019 | Esmya (PDF 115 KB, 2 pages) | Important safety update following reports of serious liver injury |
| 21 December 2018 | Epilim (PDF 68 KB, 1 page) | Updated educational materials for use in women of child-bearing potential |
| 5 December 2018 | Tecentriq (PDF 501, 2 pages) | Revision of indication for treatment of locally advanced or metastatic urothelial carcinoma |
| 5 December 2018 | Tecentriq (PDF 645 KB, 2 pages) | New important identified risk: Nephritis |
| 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 |
| 14 December 2001 | Cheng Kum/Shen Loon | Betamethasone found in herbal medicine capsules |
