Reuters Investigation Points to J&J Coverup for Diabetes Drug Risk

 

In March 2013, Janssen Pharmaceutical, a Johnson & Johnson company, reported that the U.S. Food and Drug Administration (FDA) had approved Invokana (canagliflozin) for adults with type 2 diabetes. It was the first in a class of drugs called sodium glucose co-transporter 2 (SGLT2) inhibitors.

The drug has a list of warnings, including the risk of lower limb amputation, dehydration and low blood pressure, genital yeast infections, severe allergic reactions, and kidney problems. The most common is the genital yeast infection. Another possible reaction is ketoacidosis, a severe complication of diabetes that is potentially life-threatening, but the FDA didn’t begin investigating the drug about ketoacidosis until after May 2015.

Now, an investigation alleges that J&J knew of the risk of ketoacidosis but covered it up. According to the investigation conducted by Reuters, less than a year after the drug was approved, senior executives were informed by safety officials of 18 patients who had been reported with diabetic ketoacidosis (DKA) within days or weeks of starting Invokana. And by July, there were 39 cases.

By the time the FDA began its investigation, J&J had sold four million prescriptions and raked in billions of dollars two years after approval. Eventually, the FDA and the European Commission (EC) ordered a warning be added to Invokana’s label.

“The March 2014 meeting, reported here for the first time,” Reuters says, “was not an isolated incident. Based on interviews with several former J&J employees and a review of company documents related to Invokana’s development, rollout and safety from 2010 to 2014, Reuters found that in the five years prior to regulators’ intervention, J&J was repeatedly alerted to Invokana’s ketoacidosis risk and took no action.”

The documents also indicated that as early as 2010, during clinical trials, J&J observed increased levels of ketones, which can lead to ketoacidosis, in patients’ blood samples.

Dr. Bruce Leslie, who led the safety team at the meeting in March 2014, had told J&J executives about the ketoacidosis risk and recommended they inform regulators in the U.S. and Europe. “I think we should get out in front of this,” Leslie told them, per his interviews with Reuters. “Otherwise, it could come back and bite us in the ass.”

The executive decided not to take action then and still didn’t by July 1, 2014, when there were 39 reported cases of ketoacidosis. It would take almost another year before the FDA initiated an investigation due to the rising numbers of reports in its reporting system.

“In my opinion,” Leslie said, “they wanted to make this safety issue go away because it threatened sales.” He resigned from J&J several months after the 2014 meetings.

Another former employee, Dr. Angelina Trujillo, a J&J medical director who worked on Invokana, told Reuters the ketoacidosis reports “was information the public needed to know.”

The drug is still on the market, and there have been thousands of ketoacidosis and related events reported. Sales did drop over the warnings, but J&J has raked in more than $6 billion since the drug was launched. In 2020, Invokana and a sister drug brought in $795 million globally. SGLT2 inhibitors are a very effective and valuable class of diabetes drugs, but they come with clear risks.

J&J stated to Reuters that it cares “deeply about the safety and well-being of patients treated with our medications. Both pre- and post-approval, [the company] has worked diligently and closely with regulatory authorities to monitor and investigate emerging safety data, to report credible signals to FDA, and to advise healthcare providers and their patients of the risk-benefit profile for Invokana.”

Invokana was the first of the SGLT2 inhibitors to hit the market but has since been joined by others, including Boehringer Ingelheim and Eli Lilly’s Jardiance (empaglifozin) and AstraZeneca’s Farxiga (dapagliflozin). All include warnings about ketoacidosis and other serious side effects, particularly the risk of leg amputations.