Cross-sectional study of medical advertisements in a national general medical journal: evidence, cost, and safe use of advertised versus comparative drugs

Table 4 EMA and FDA safety announcements published after advertising (2015–2018)

Drug	Clinical findings	Regulator	Regulatory action	Announcement
Canagliflozin	Increased risk of ketoacidosis	FDA	Undertaking further investigations (all SGLT2-inhibitors)	May 2015 [41]
Canagliflozin	Increased risk of bone fractures and decreased bone mineral density	FDA	Warning added to the FDA prescriber information	Sep 2015 [42]
Canagliflozin	Increased risk of ketoacidosis, urosepsis, and pyelonephritis	FDA^a	Warning added to the FDA prescriber information (all SGLT2-inhibitors)	Dec 2015 [43]
Aripiprazole	Impulse-control problems (gambling, binge eat, shop, sex)	FDA	Warning added to the FDA prescriber information^a	May 2016 [44]
Canagliflozin	Interim results: Increased risk of leg and foot amputations	FDA	Undertaking further investigations	May 2016 [45]
Canagliflozin	Risk of acute kidney injury	FDA	Revised warning on the FDA prescriber information	June 2016 [46]
Inhaled corticosteroids for COPD	Increased risk of pneumonia	EMA	Updated product information	July 2016 [47]
Canagliflozin	Increased risk of foot and leg amputation	FDA^a	Addition of FDA boxed warning	May 2017 [48]
Combined beta₂-agonist + steroid inhalation	No increased risk of serious asthma-related outcomes	FDA	Removal of FDA boxed warning	Dec 2017 [49]
Modified-release paracetamol	Difficulties in managing overdoses	EMA	Withdrawal of product from EU market	Dec 2017 [50]
Canagliflozin	Increased risk of necrotising fasciitis of the perineum	FDA	Warning added to the FDA prescriber information (all SGLT2-inhibitors)	Aug 2018 [51]

Announcements listed in chronological order. ^aThe warning pertained to all formulations of aripiprazole, both oral tablet and intramuscular injections. ^bSimilar referral issued by EMA

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