FDA: Diabetes drugs don’t need death warning

April 14, 2015

Onglyza, the diabetes medication manufactured by AstraZeneca, may be associated with an increased death rate, according to a preliminary review by the Food and Drug Administration (FDA).

While diabetes medications Onglyza and Nesina should include information about the risk of heart failure, the drugs do not increase the risk of cardiovascular death, stroke or heart attack, an advisory committee to FDA said.

Originally, a preliminary review by FDA published last Friday said that Onglyza, (AstraZeneca) may be associated with an increased death rate.

FDA's published the review on its website on Friday, ahead of its April 14 Endocrinologic and Metabolic Drugs Advisory Committee Meeting. The committee will not only discuss the safety of Onglyza, but will also look at diabetes drug Nesina from Takeda Pharmaceutical Co.

However, on Tuesday, the committee did not recommend any restrictions on prescribing the drugs.

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The review revealed that more than 16,000 patients taking Onglyza in the SAVOR study had an increased risk of hospitalization due to heart failure. FDA said the heart failure risk is valid and that there may a possible increased risk of death, according to a Reuter’s article.

The causes of death were often "multifactorial" and some patients may have had several serious medical conditions prior to death, according to Reuters.

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A similar large study of Nesina, did not raise similar concerns, according to the FDA review.

AstraZeneca said the SAVOR study met the objective of showing that patients taking Onglyza were not at greater risk as measured by a composite benchmark comprising cardiovascular death, non-fatal heart attack and non-fatal ischemic stroke, Reuters reported.

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