US FDA investigates AZ, J&J and B-I's type 2 diabetes drugs after adverse events

By Dan Stanton contact

- Last updated on GMT

US FDA investigates AZ, J&J and B-I's SGLT2 inhibitors type 2 diabetes
Diabetes drugs made by J&J, AstraZeneca and Boehringer-Ingelheim are being investigated by the US FDA after 20 cases of acidosis resulting in hospitalisation were recorded.

Between May 2013 and June 2014, the US Food and Drug Administration recorded 20 cases of acidosis resulting in emergency room visits or hospitalisation in patients who had taken sodium-glucose cotransporter-2 (SGLT2) inhibitors, used to help control blood sugar in adults with type 2 diabetes.

SGLT2 inhibitors contain the active ingredients canagliflozin, dapagliflozin, and/or empagliflozin, and while the agency has urged patients to continue taking their prescriptions as directed, it warns such drugs could cause ketoacidosis, a serious condition where the body produces high levels of blood acids.

The drugs affected are Janssen’s Invokana and Invokamat, AstraZeneca’s Farxiga and Xigduo XR, and Boehringer-Ingelheim’s Jardiance and Glyxambi.

The FDA is investigating this safety issue and will determine whether changes are needed in the prescribing information for SGLT2 inhibitors.

A relatively new treatment for type 2 diabetes, SGLT2 inhibitors lower blood sugar by reducing the amount of glucose being absorbed in the kidneys so that it is passed out in the urine.

Invokana was approved in March 2013, AZ’s Farxiga in January 2014 and Boehringer-Ingelheim’s Jardiance in August the same year, after rectifying manufacturing issues cited in a complete response letter​.

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