April 2015 FDA Advisory Committee Voted For An Onglyza Drug Label Change About Side Effects Risks, With One Panelist Voting Of An Onglyza Recall
As previewed in our March 2015 article, "Cardiovascular Safety Issues For Onglyza And Kombiglyze Will Be Discussed At April 2015 FDA Advisory Committee Meeting", the results of Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial for for AstraZeneca's relatively new diabetes drugs Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCI extended-release) were discussed recently by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee.
For those who want to get in-depth on this emerging drug safety issue concerning Onglyza and Kombiglyze XR, you can read the "Briefing Information for the April 14, 2015 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC)".
In the alternative, for the so-called "bottom line" as regards this recent Onglyza FDA Advisory Committee meeting, you can look at the "Minutes for the April 14, 2015 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC)", from which we get this information:
VOTE: Which action do you recommend FDA take regarding the totality of the safety information (Cardiovascular and other) obtained in SAVOR? After the voting is completed, please explain your answer and specify the safety issue(s) of concern, if applicable. Also recommend additional studies if any are needed.
A. No change to labeling (i.e., no new safety information needs to be added to the label)
B. Change labeling to add new safety information
C. Change labeling to add new safety information and restrict distribution
D. Withdraw saxagliptin from the market
Vote Results: A = 0 B = 14 C = 0 D = 1
Committee Discussion: The majority of the committee (14 members) voted that changes should be made to the saxagliptin labeling to add new safety information, including potential increased risk of heart failure, all-cause mortality, decreased renal function, and acute pancreatitis based on the safety findings from the SAVOR trial. The committee further specified that labeling should communicate the potential increased risk for heart failure in patients with a previous history of heart failure and decreased renal function. The majority of the committee agreed that restriction of distribution is not needed. One member of the committee voted to withdraw saxagliptin from the market because SAVOR did not demonstrate a cardiovascular benefit. The committee did not recommend any additional studies....
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For some background, one might want to read this article, "Possible Link Between Heart Failure And Onglyza Diabetes Type 2 Drug Is Being Investigated By FDA, As Announced In February 2014", which wrote back in April 2014.
We are watching to see whether the FDA will follow the advice given at this April 2015 Advisory Committee meeting and mandate that AstraZeneca revise the drug labels for Onglyza and Kombiglyze XR to warn about the increased risks of side effects.
In addition, we are investigating cases of patients who developed heart failure after using the Type 2 diabetes drugs Onglyza and Kombiglyze XR.