Table 1.
Advisory characteristics
| Advisory (drug-risk group) | Index country | Control | Advisory date | Advisory type |
| (a) Advisories without dose-related advice* | ||||
| Aripiprazole-impulse control disorders30 | CA | DK | 2 November 2015 | Alert |
| Azithromycin-cardiac arrhythmias43 | USA | USA† | 12 March 2013 | Alert |
| Clopidogrel-acquired haemophilia38 | DK | AU | 28 August 2013 | DHPC |
| Febuxostat-epidermal and dermal conditions27 | UK | USA† | 6 May 2012 | DHPC |
| Finasteride-breast cancer male34 | UK | CA | 1 December 2009 | Alert |
| Fingolimod-PML40 | USA | CA | 29 August 2013 | Alert |
| Insulin-glargine-neoplasm malignant50 | USA | DK | 1 July 2009 | Alert |
| Isotretinoin-epidermal and dermal conditions32 | CA | DK | 11 February 2010 | DHPC |
| Ketoconazole-adrenal gland disorders‡41 | USA | USA† | 26 July 2013 | Alert |
| Leflunomide methotrexate-hepatotoxicity49 | USA | AU | 13 July 2010 | Alert |
| Methylphenidate-sexual dysfunction39 | USA | USA† | 17 December 2013 | Alert |
| Mycophenolate-aplasia pure red cell33 | UK | USA†§ | 2 June 2009 | DHPC |
| Nitrofurantoin-lack of effect36 | UK | AU¶ | 1 August 2013 | Alert |
| Olmesartan-malabsorption42 | USA | AU¶ | 3 July 2013 | Alert |
| Ondansetron-cardiac arrhythmias45 | USA | AU¶ | 15 September 2011 | Alert |
| Pioglitazone-bladder cancer48 | USA | USA† | 15 June 2011 | Alert |
| Quetiapine-metabolic syndrome29 | UK | UK† | 23 December 2011 | DHPC |
| Tacrolimus-neoplasm malignant‡28 | DK | CA | 1 May 2012 | DHPC |
| Testosterone-cardiovascular disorder31 | CA | UK | 15 July 2014 | Alert |
| Topiramate-congenital anomaly37 | DK | CA | 1 March 2011 | DHPC |
| (b) Advisories with dose-related advice* | ||||
| Citalopram escitalopram-cardiac arrhythmias46 | USA | USA† | 24 August 2011 | Alert |
| Fluconazole-congenital anomaly47 | USA | USA† | 3 August 2011 | Alert |
| Hydroxyzine-cardiac arrhythmias35 | UK | CA | 29 April 2015 | Alert |
| Zolpidem-cognitive impairment44 | USA | USA† | 10 January 2013 | Alert |
Created by the authors.
*Dose-related advice was defined as advice that revised the recommended or maximum dose of a drug or warned about risk associated with higher doses.
†Historical control.
‡Advisory applied to a specific route of administration (oral for ketoconazole and topical for tacrolimus), so analysis was restricted to relevant forms of the drug.
§A historical control from the UK was unavailable due to a lack of sufficient preadvisory data, so a US historical control was used.
¶Restricted to drug use of concessional beneficiaries (eg, seniors and individuals with a low household income), due to better data capture in this population for these drugs.
AU, Australia; CA, Canada; DHPC, Direct Healthcare Professional Communication; DK, Denmark; PML, progressive multifocal leucoencephalopathy.