Drugs

Public Citizen Asks Diabetes Drug Boxed Warning

Public Citizen is petitioning FDA to require a Boxed Warning for all sodium-glucose cotransporter-2 (SGLT-2) inhibitor drugs contraindicating their use in patients with Type 1 diabetes. “There is irrefutable evidence from multiple randomized clinical trials that the SGLT-2 inhibitors canagliflozin (Janssen’s Invokana), dapagliflozin (AstraZeneca’s Farxiga), and empagliflozin (Boehringer Ingelheim’s Jardiance) — which are approved for treatment of adults with Type 2 diabetes but not Type 1 diabetes … — cause a significant increase in the incidence of life-threatening diabetic ketoacidosis (DKA) when administered to patients with Type 1 diabetes,” the petition says.

The advocacy group says that the current off-label prescribing of these drugs to patients with Type 1 diabetes, which it says has been well documented by FDA, “is enabled by the dangerous incompleteness and submerged prominence of the warnings about the risk of DKA in the drugs’ current product labeling.”

In addition to a Boxed Warning, the petition asks for the addition of cautionary language in other sections of the labeling.

A Public Citizen media statement says that since 2013 FDA has received 550 reports of DKA in patients with Type 1 diabetes who were treated with the drugs. “Most of these cases resulted in hospitalization (411 cases),” the statement says, “and many were considered life-threatening (68 cases).”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome