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Diabetes Drugs Could Harm Kidneys, Warns FDA

XTALKS VITALS NEWS

Diabetes Drug

In light of the findings, the regulatory agency is now requiring the pharmaceutical companies to add revised warning labels to their drug’s packaging.

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June 16, 2016 | by Sarah Massey, M.Sc.

Tweet: #Diabetes drugs have been shown to be associated with acute kidney injury http://ctt.ec/I6euy+

Two drugs used to treat type 2 diabetes – Johnson & Johnson's Invokana and AstaZeneca's Farxiga – have been shown to be associated with acute kidney injury, according to the US Food and Drug Administration (FDA). In light of the findings, the regulatory agency is now requiring the pharmaceutical companies to add revised warning labels to their drug’s packaging.

Between March 2013 and October 2015, over 100 cases of acute kidney injury associated with use of the diabetes drugs, were reported to the FDA. Approximately 50 percent of these adverse events occurred in the first month of treatment, with most patients recovering after they stopped taking the drugs.

Invokana and Farxiga belong to a class of drugs known as SGLT-2 inhibitors, which help diabetic patients control blood sugar levels by inducing the kidney to expel sugar through the urine. An earlier warning regarding the increased incidence of foot and leg amputations during the clinical trial for Invokana was issued by the FDA, however a direct link between the drug and limb loss has yet to be established.

Both diabetes drugs have become significant sources of revenue for their respective pharmaceutical companies. Since its approval in March 2013, Invokana has generated considerable sales, making $1.31 billion in 2015 alone. The majority of the drug’s sales occurred in the US market, with growth slowing in the first quarter of this year.



In 2015, Farxiga earned $492 million, with a 119 percent growth rate over 2014. According to AstraZeneca, the increased sales could be attributed to a bigger investment in promotional tools, and expanded patient access to the drug.

To identify any cardiovascular benefit associated with taking Farxiga, AstraZeneca is currently conducting an outcomes clinical trial. Interim data for the clinical trial is expected to be released sometime in 2017.

Eli Lilly and Boehringer Ingelheim's Jardiance demonstrated improved cardiovascular outcomes in 2015, prompting other diabetes drugmakers to assess their drugs’ effect on heart health. While Jardiance also belongs to the SGLT-2 inhibitor class of drugs, the FDA did not include it in its warning.

The safety alert issued by the FDA did, however, include Johnson & Johnson’s Invokamet and AstraZeneca’s Xigduo XR. Invokamet is a combination drug containing both the SGLT-2 inhibitor and the standard diabetes drug, metformin.


Keywords: Diabetes, FDA, Adverse Event


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