The U.S. Food and Drug Administration last month warned of serious blood problems linked to use of six diabetes drugs, including AstraZeneca PLC’s Farxiga and Janssen Pharmaceuticals Inc.’s Invokana. In a safety alert, the FDA announced receiving 20 reports from March 2013 to June 2014 of so-called diabetic ketoacidosis — a disorder involving elevated levels of blood acids known as ketones — in patients using the six drugs. Every patient had to be hospitalized or visit the emergency room, and other patients have continued to be affected in ensuing months, regulators said.
The afflictions, according to the FDA, were unusual because they mainly occurred in patients with Type 2 diabetes, whereas diabetic ketoacidosis is normally seen in individuals with Type 1 diabetes. All the adverse events occurred in a class of drugs called sodium-glucose cotransporter-2 inhibitors, or SGLT2 inhibitors. It’s not yet known whether any labeling revisions will be required. Regulators wrote:
We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs.
Regulators implicated Astrazeneca’s Farxiga, or dapagliflozin, as well as a related company product called Xigduo XR, which combines dapagliflozin and metformin. The FDA also cited Janssen’s Invokana, or canagliflozin, as well as a related company product called Invokamet, which combines canagliflozin and metformin. In addition, the FDA warned of ketoacidosis in patients using Jardiance, or empagliflozin, as well as Glyxambi, which combines empagliflozin and linagliptin. Each of the products is co-marketed by Boehringer Ingelheim GmbH and Eli Lilly & Co. Inc.
Patients using any of the drugs should be on the lookout for difficulty breathing, nausea, vomiting, abdominal pain, confusion and unusual fatigue or sleepiness as potential symptoms of ketoacidosis, the FDA said. The median length of time from start of treatment to symptoms was two weeks. According to the Mayo Clinic, while ketoacidosis is treatable, it can lead to loss of consciousness and even be fatal in some instances. Many of the drugs involved in the announcement are not strangers to safety concerns and controversy.
In March, the consumer advocacy group Public Citizen complained to the FDA that Farxiga, Invokana and Jardiance were being improperly marketed as weight-loss products. In 2014, Farxiga won clearance despite links to bladder cancer, and in 2013, Invokana was approved despite earlier concerns about cardiovascular and bone risks. Given their similarities, the drugs are serious rivals for shares of the burgeoning diabetes market, and sales are likely to be robust if safety problems can be contained. Invokana and Invokamet, for example, racked up U.S. sales of $266 million in the first quarter of 2015, according to Janssen parent Johnson & Johnson.
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