Why not an educational campaign about DKA risk?
In an interview, Hilary Nathan, policy & communications director at JDRF International, explained that the charity has its theories as to why dapagliflozin has been withdrawn for type 1 diabetes.
What AstraZeneca is saying, “and what we don’t agree with them on,” is that the “black triangle” warning that has to be put onto the drug due to the increased risk of DKA in type 1 diabetes is “misunderstood by health care practitioners” outside of that specialty and that “by having that black triangle, it will inhibit take-up in those other markets.”
In other words, “there will be less desire to prescribe it,” ventured Ms. Nathan.
She continued: “For us, we feel that if a medicine is deemed safe and efficacious, it should not be withdrawn because of other patient constituencies.”
“We asked: ‘Why can’t you do an educational awareness campaign about the black triangle?’ And the might of AstraZeneca said it would be too big a task.”
Ms. Nathan was also surprised at how the drug could be withdrawn without any warning or real explanation.
“How is it possible that, when a drug is approved there are multiple stakeholders that are involved in putting forward views and experiences – both from the clinical and patient advocacy communities, as well as obviously the pharmaceutical community – yet [a drug] can be withdrawn by a ... company that may well have conflicts of interest around commercial take-up.”
She added: “I feel that there are potentially motives around the withdrawal that AstraZeneca are still not being clear about.”
Perhaps a further clue as to the real motives behind the withdrawal can be found in an announcement, just last week, by the British MHRA.
“The decision by the marketing authorization holder to voluntarily withdraw the indication in type 1 diabetes followed commercial considerations due to a specific European-wide regulatory requirement for this authorization,” it said.
“The decision was not driven by any new safety concerns, such as the already known increased risk of DKA in type 1 diabetes compared with type 2 diabetes.”
Separately, a new in-depth investigation into when Johnson & Johnson, which markets another SGLT2 inhibitor, canagliflozin (Invokana), first knew that its agent was associated with DKA has revealed multiple discrepancies in staff accounts. Some claim the company knew as early as 2010 that canagliflozin – first approved for type 2 diabetes in the United States in 2013 – could increase the risk of DKA. It was not until May 2015 that the FDA first issued a warning about the potential risk of DKA associated with use of SGLT2 inhibitors, with the EMA following suit a month later. In Dec. 2015, the FDA updated the labels for all SGLT2 inhibitors approved in the United States at that time – canagliflozin, empagliflozin, and dapagliflozin – to include the risks for ketoacidosis (and urinary tract infections).
Forxiga (dapagliflozin) is manufactured by AstraZeneca. No relevant financial relationships declared.
A version of this article first appeared on Medscape.com.