- As far back as 2010, during clinical trials of its diabetes drug Invokana J&J, researchers learned that some patients showed increased levels of ketones
- During a 2014 meeting, officials were told by the company’s security team that people taking Invokana were falling seriously ill.
- The company had also received similar reports about 18 patients suffering from diabetic ketoacidosis, or DKA, within days or weeks of starting Invokana.
- Dr Bruce Leslie said he had recommended that J&K officials alert regulators to get ahead of any future disputes but ultimately no action was taken.
- J&J has been forced to settle several of the nearly 1,200 Invokana lawsuits related to drug dealing with alleged fraud, negligence and other injuries
- Among those sued was Veronica Ryan, a 58-year-old type 2 diabetic patient in Tennessee who became seriously ill after being prescribed the drug.
Healthcare maker Johnson & Johnson is accused of keeping quiet about the $1 billion diabetes drug Invokana after warnings of its potentially fatal side effects.
An investigation showed that, as of 2010, during clinical trials for INVOKANA Researchers at J&J learned that some patients showed increased levels of acids called ketones in their blood.
But J&J made no effort to bring the issue to the regulators, and even after the drug was released to treat type 2 diabetes. J&J officials repeatedly dismissed safety concerns, Reuters reported, and launched the drug in spring 2013.
During a 2014 meeting, less than a year after the drug hit the market and Johnson & Johnson generated nearly $1 billion in sales, executives were told by the company’s security team that People Invokana was falling seriously ill.
Dr. Bruce Leslie (pictured) said he had recommended that J&K officials alert regulators to get ahead of any future disputes but ultimately no action was taken.
Among those sued was Veronica Ryan, (pictured) a 58-year-old type 2 diabetic patient in Tennessee who became seriously ill after being prescribed the drug.
Ryan has since recovered, and has filed a lawsuit against J&J over his ordeal
Around the same time, the company received similar reports from doctors across the United States about 18 patients ill with a rare and potentially fatal buildup of acid in the blood, known as diabetic ketoacidosis, or DKA, Invokana within days or weeks of starting.
Dr. Bruce Leslie, who led the security team at the March 2014 meeting, told Reuters that he had recommended that J&K officials alert US and European regulators to avoid any future disputes. ‘Otherwise, it may come back and bite us in the ass,’ but ultimately no action was taken.
According to Leslie, in A few weeks after the March 2014 meeting he received a letter from his boss warning him that he could be fired for contributing to an ‘unnecessarily controversial’ discussion on Invokana.
A few weeks later, the Japanese company that developed and licensed the drug told J&J that the increased ketones were a potential risk.
Among those injured by the drug was Veronica Ryan, a 58-year-old type 2 diabetic patient in Chattanooga, Tennessee, who later sued.
Ryan was prescribed Invokana in September 2015, but told Reuters that over the next few weeks she felt increasingly weak and nauseated and her heart was racing, and she could not sit in bed without feeling out of breath. Was.
She was hospitalized with a diagnosis of ketoacidosis, her medical records and court documents show. Doctors couldn’t determine what caused the reaction, Ryan said, and Invokana was never mentioned.
Two weeks after she was discharged, her prescription for Invokana was refilled and she was back in the hospital.
Ryan’s medical records show that she again suffered from ketoacidosis. She was struggling to breathe, and her kidneys were starting to shut down. His close friends gathered at the hospital to offer prayers. Her husband called her family and told that her condition was serious.
‘They thought it was my last day,’ Ryan told Reuters.
In December 2015, during Ryan’s 12-day hospital stay, the FDA announced that it would require Invokana and other drugs in its class to add warnings about ketoacidosis.
Ryan returned home in mid-December. But she didn’t feel strong enough to go back to work until two months later. Ryan dropped his lawsuit against J&J in 2019. She said she could not comment on the resolution of her case and J&J declined to comment on Ryan’s case.
Ryan said, ‘I warn anyone with diabetes to be careful with Invokana. ‘It seemed like it was slowly killing me.’
“In my opinion, they wanted to address this security issue because it threatened sales,” Leslie, who left the company several months after the 2014 meeting, told Reuters.
The documents showed that months later, in July 2014, the company learned of 39 cases of ketoacidosis, but remained silent, Reuters reported.
It was not until May 2015, Two years after Invokana hit the market—and four million prescriptions—the public first heard about the drug’s association with ketoacidosis.
came after the announcement The US Food and Drug Administration (FDA) announced an investigation that led to warnings on the label by US and European regulators on Invokana and its recent entry for this new class of drugs, known as SGLT2 inhibitors. Is.
Throughout all of this, the company continued to pour millions of dollars into marketing Invokana as a safe, effective treatment for millions of people with type 2 diabetes, Reuters reported.
The drug is still on the market, even with thousands of reports to the FDA. Of ketoacidosis and related events, however, sales have declined because drug labels are replete with warnings about ketoacidosis and other potential adverse effects.
But eventually J&J was able to make Invokana has generated more than $6 billion in revenue since its launch, and the drug continues to make money.
In 2020, Invokana (pictured) and a sister drug raised $795 million worldwide for Johnson & Johnson
Johnson & Johnson said in a statement that it ‘cares deeply about the safety and well-being of patients treated with our drugs’
In 2020, Invokana and a sister drug pulled in $795 million worldwide for Johnson & Johnson, which defended its decision to ignore warnings about the drug.
In a statement to Reuters, the company said it “cares deeply about the safety and well-being of patients treated with our medicines.” Pre- and post-approval, (the company) has worked closely with regulatory authorities to monitor and examine emerging safety data, report reliable indications to the FDA, and advise healthcare providers and their patients about the risk-benefit profile. and worked closely. Invokana.’
But Johnson & Johnson has been forced Settle many of the nearly 1,200 Invokana lawsuits gathered in multi-district lawsuits in New Jersey federal court regarding drug, alleged fraud, negligence or failure to warn about the risk of diabetic ketoacidosis, amputation and other injuries .
According to Leslie, the company’s delay in advising regulators was an unintentional decision that made people like Ryan sick.
‘In my opinion, the company was not proactive enough in notifying regulators, and hundreds of people got sick. That’s a tragedy for me,’ he told Reuters.