FDA issues more diabetes drug warnings
pharmafile | May 18, 2015 | News story | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | AstraZeneca, Boehringer, J&J, JJ, lilly
The FDA has warned that a class of type 2 diabetes drugs manufactured by several big pharma firms could cause a serious blood condition.
The US regulator says that sodium-glucose cotransporter-2 (SGLT2) inhibitors – such as Johnson & Johnson’s Invokana (canagliflozin), AstraZeneca’s Farxiga (dapagliflozin) and Jardiance (embagliflozin) from Lilly and Boehringer – could lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones.
“Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness,” the agency says in its statement.
In the FDA Adverse Event Reporting System (FAERS) database there were 20 reported cases of acidosis in patients treated with SGLT2 inhibitors between March 2013 and 6 June 2014, and more reports have been received since then. All the cases resulted in the patient requiring emergency room visits or hospitalisation.
SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Invokana, Farxiga and Jardiance are relatively new approvals, and have so far been performing well for their respective manufacturers. Farxiga helped keep AstraZeneca’s revenues afloat during the first quarter of 2015 with a 47% increase in sales, while Glyxambi, a combination of Jardiance and Lilly’s Tradjenta (linagliptin), was approved by the FDA in January.
The safety of diabetes drugs in general has been an area of growing concern for the regulator, though. In 2008 it issued guidance requiring firms to conduct post-marketing trials to show that new treatments do not come with an increased risk of heart failure. Results from these trials have led to fears that another class of treatments, known as DPP-4 inhibitors, could ‘significantly’ increase mortality, and DPP-4 inhibitors from AZ and Takeda have received label updates as a result.
The FDA says it will continue to investigate the issue and determine whether changes are needed in the prescribing information for SGLT2 inhibitors.
George Underwood
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