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FDA Orders Black Box Warning for Invokana

FDA Orders Black Box Warning Label on InvokanaThe Food and Drug Administration has added a black box warning for type-2 diabetes drug Invokana due to the risk of users suffering foot and leg amputations.

“Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations,” the agency said in its Drug Safety Communication released on May 16, 2017.

Issuance of a black box warning is the strongest warning the FDA provides and is a signal to doctors and patients that the drug may lead to serious health problems.

Invokana belongs to a class of drugs known as SGLT2 inhibitor Type 2 diabetes medications and include Johnson & Johnson’s Invokana, AstraZeneca’s Farxiga (dapagliflozin) and Boehringer Ingelheim and Lilly’s Jardiance (empagliflozin).

SGLT2 inhibitors work by stopping the kidneys from reabsorbing glucose into the blood and passing it out in urine.  The FDA has received reports potentially linking these drugs to a form of acute pancreatitis, which occurs when the pancreas, the organ responsible for creating insulin, swells and suddenly becomes inflamed.  Acute pancreatitis is painful, and about 10 percent of cases are fatal. Common symptoms include nausea and vomiting, rapid pulse, swollen abdomen and fever. Treatment usually involves hospitalization, antibiotics and a liquid diet.  The most common causes of acute pancreatitis are gallbladder stones or heavy alcohol consumption. But some medications can also cause it. The FDA previously warned about acute pancreatitis in the DPP-4 class of Type 2 diabetes drugs, and is now investigating adverse event reports for SGLT2 inhibitors.

According to the FDA, “Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.

Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur.

Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment.

Invokana is the best-selling drug in this class and has had a checkered history.  After the drug’s approval in 2013, the FDA found certain safety issues concerning the drug including diabetic ketoacidosis (DKA), kidney injury and urinary tract infections that may lead to blood infections.

If you or a loved one have taken Invokana or a similar drug and have suffered kidney injury, please contact Attorney Joe Saunders for a free initial consultation.

New Study Finds More than 30% of FDA Approved Drugs Have Safety Issues

A research study conducted by Yale University researchers has determined that 32% of FDA approved drugs have safety issues.  The study has been published in the May issue of The Journal of the American Medical Association. While many of the safety issues found do not warrant removal from the marketplace, the researchers noted that theirContinue Reading

New Mexico Judge Orders Zimmer Inc to Pay Millions

After a two week trial in Albuquerque, New Mexico, a judge cited “unreasonably dangerous design,” and ordered medical device manufacturer Zimmer Inc. to pay more than $2 million to a New Mexico man for a defective Zimmer Kinectiv hip implant. In the verdict, Judge Nan G. Nash highlighted that Zimmer was liable for manufacturing andContinue Reading

Multi-Million Dollar Verdict in Ethicon Vaginal Mesh Lawsuit

Johnson & Johnson has again been ordered to pay out millions to a woman who suffered serious injuries after being implanted with one of their vaginal mesh devices. In Philadelphia, A jury found for a plaintiff and awarded a $20 million verdict against Johnson & Johnson’s Ethicon division, over complications with the Ethicon TVT-Secur transvaginalContinue Reading

As Xarelto Trial Begins, Manufacturers Deny Drug’s Risks

As the first Xarelto bellwether trial began last week in New Orleans, drug manufacturers Johnson & Johnson and Bayer were on the defensive attempting to deny allegations that they didn’t reveal the serious dangers caused by the blood thinner. While Xarelto has been a blockbuster drug for its manufacturers, thanks in large part to televisionContinue Reading

Clinical Trials – On the Front Lines of Medicine

We don’t often think about where lifesaving drugs and medical treatments come from; in fact, we don’t tend to think of them at all until we’re beyond the point of needing them. When we’re injured or fall ill enough to be hospitalized, medical professionals spring to—seemingly—automatic action in order to implement a series of triedContinue Reading

New Reports Show Link Between Breast Implants and Rare Blood Cancer

In March the U.S. Food and Drug Administration reported that a rare blood cancer first linked to breast implants in 2011 had also been associated with 9 deaths. More alarm was raised yesterday when an Australian report confirmed five more cases of blood cancer linked to breast implants, bringing the total to 51 women inContinue Reading

Target Recalls More than Half Million Easter Toys Due to Ingestion Hazard

The Consumer Product Safety Commission has announced that Target has recalled 560,000 of its water-absorbing Easter and Dino toys.  If the small toy is ingested, it can expand inside a child’s body and cause intestinal obstructions, resulting in severe discomfort, vomiting, dehydration and could be life threatening. Surgery is required to remove the toy fromContinue Reading

Takata Pleads Guilty to Criminal Wire Fraud

Even though in February Takata plead guilty to criminal wire fraud for covering up engineering defects that have led to at least 17 deaths worldwide. Consumers shouldn’t get complacent. That guilty plea accompanies the biggest recall in automotive history. With it Takata agreed to a $1 billion settlement, including $850 million to compensate automakers for repairs,Continue Reading

Mylan EpiPens Recalled Over Potential Defect

Meridian Technologies has recalled 13 lots of Mylan Labs EpiPens and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured byContinue Reading



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