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Invokana 112 articles

Invokana doubles risk of ketoacidosis

A class of type 2 diabetes medications called SGLT2 inhibitors doubles the risk of developing the life threatening condition ketoacidosis, according to a study published in the New England Journal of Medicine. The findings arose from the largest study to date investigating whether SGLT2 inhibitors, such as the widely prescribed Invokana, increase the risk of diabetic ketoacidosis, or DKA. It was conducted by researchers with the Brigham and Women’s Hospital in Boston, Massachusetts. Researchers put the risk of developing DKA at between 5 and 8 per 1,000 for new users of SGLT2 inhibitors. “We found a doubling in the risk ... Read More

Study confirms ketoacidosis risk with diabetes drugs

A new study published in the New England Journal of Medicine confirms that a class of type 2 diabetes drugs increases the risk of a serious blood condition called ketoacidosis and “essentially confirms what doctors had already suspected,” said Dr. Stanislaw Klek, an endocrinologist at NYU Winthrop Hospital in Mineola, New York. “It is important to be aware of this potential complication and monitor for symptoms of diabetic ketoacidosis, particularly during periods of illness,” he added. The drugs in question are in a class of type 2 diabetes medications known as SGLT2 inhibitors. Invokana was the first in the class ... Read More

Invokana warnings may hurt sales

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) were both prompted to investigate reports of amputation risk from clinical trial data involving canagliflozin, the active ingredient in the type 2 diabetes drugs Invokana and Invokamet. After the EMA’s review, the European agency opted to place increased amputation risk warnings on all drugs in the SGLT2 inhibitors class. The FDA, however, opted to put its strongest warning – a black box warning – only on the safety labels of Invokana and Invokamet. According to Seeking Alpha, there is no evidence that other drugs in the SGLT2 ... Read More

Amputations more likely in Invokana users

People with type 2 diabetes are at an increased risk of developing neuropathy causing weakness, numbness and pain in the extremities that can lead to the need for amputation. But diabetics who take Invokana or Invokamet, including Invokamet XR, may be twice as likely to need a foot or leg amputation compared to patients not taking the drugs, according to newly released clinical trial data. The study results prompted the Food and Drug Administration (FDA) to require Johnson & Johnson’s subsidiary Janssen Pharmaceuticals to put a black box warning on the drugs’ safety labels – the most serious type of warning ... Read More

Diabetes drug linked to amputations

EndocrineWeb, an ezine for people with endocrine disorders, cautioned readers about the latest warning added to the safety labels of the type 2 diabetes medications Invokana and Invokamet, which involves an increased risk for lower limb amputations. Both Invokana and Invokamet contain the active drug ingredient canagliflozin. Invokamet combines canagliflozin with metformin. The medications were approved in 2013 and 2014, respectively. They belong to a new class of type 2 diabetes medications called SGLT2 inhibitors. The May 16 warning was not unexpected, said J. Michael Gonzalez-Campoy, MD, PhD, FACE, who serves as medical director and CEO of the Minnesota Center ... Read More

Invokana warning should benefit rivals

The latest black box warning to land on packages of the type 2 diabetes drug Invokana (as well as its metformin combination drug Invokamet) may boost rival drug Jardiance’s sales even higher, according to Leerink Partners analyst Seamus Fernandez. He predicted the “immediate reaction” from prescribing physicians would be to switch patients taking Invokana to another drug in the same SGLT2 inhibitor class with fewer red flags, namely Eli Lilly and Boehringer Ingelheim’s Jardiance or AstraZeneca’s Farxiga. He compared the same-drug-class switch as being similar to that made years ago when the type 2 diabetes drugs Avandia was tied to ... Read More

Invokana cases progress amid new warnings

The federal multidistrict litigation (MDL) involving nearly 300 lawsuits alleging the type 2 diabetes drug Invokana caused ketoacidosis or kidney damage continues to move forward in the U.S. district Court of New Jersey, as new concerns over the medication come to light. Within the past three weeks, the court has established an initial discovery plan that also covers how the selection of bellwether cases will be conducted, a well as scheduling and trial dates. The first bellwether is expected to begin in September 2018. The lawsuits name Invokana manufacturer Johnson & Johnson and its subsidiary Janssen Pharmaceuticals. The companies are ... Read More

Invokana linked to amputation risk

People taking the type 2 diabetes drug canagliflozin, the active ingredient in the brand name drugs Invokana, Invokamet and Invokamet XR, are at an increased risk of leg and foot amputations, the Food and Drug Administration (FDA) warned based on a safety review of two large clinical trials. As a result, the safety labels of the drug will also be updated to include the agency’s most prominent warning, called a Boxed Warning, regarding this risk. “Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcer, or infections in your ... Read More

Invokana sales slump as lawsuits mount

U.S. sales of the top selling type 2 diabetes drug Invokana, made by Johnson & Johnson subsidiary Janssen Pharmaceuticals, dropped by $50 million during the first quarter of 2017, as lawsuits against the drug makers continue to mount over Invokana side effects. Johnson & Johnson and Janssen face more than 230 Invokana lawsuits centralized in federal multidistrict litigation in the U.S. District Court in New Jersey. All pending cases were filed by individuals who claim to have developed kidney damage or ketoacidosis after using the drug. Ketoacidosis is a dangerous condition in which too much acid builds up in the ... Read More

Class of type 2 diabetes drug may offer heart benefits, but patients must weigh other risks

Data presented at the American College of Cardiology Scientific Session suggested that patients taking a class of type 2 diabetes drugs called SGLT2 inhibitors were at lower risk of being hospitalized for heart failure. But that benefit may come at a cost. People with type 2 diabetes are already at risk for various cardiovascular complications. Heart failure is one of the most common, said Mikhail Kosiborod, MD, professor of medicine at the University of Missouri School of Medicine in Kansas City in an interview with Cardiology Today. “Not only that, but it’s arguably the most morbid of (heart related) complications ... Read More