Widespread FDA Diabetes Drug Recalls and Warnings

Diabetes Drug Warnings

Over the past decade, federal regulators have issued a steady stream of FDA warnings and recalls for diabetes drugs such as Invokana, Victoza, Actos, and Avandia. Danger after danger has been discovered, all through post-market adverse event reporting – that is, through the experiences of innocent patients who have developed severe and unexpected side effects.

More than 30 million Americans suffer from diabetes and require medications to help their body maintain safe glucose levels. Ranging from Invokana limb amputation and Fourier's gangrene to Victoza pancreatic cancer, diabetes drug problems are dangerous and threatening. This page contains a thorough overview of the many recalls and FDA diabetes drug safety warnings issued this decade.

FDA Invokana Warnings

The number and variety of FDA Invokana warnings are enough to scare any patient away, and safety experts have questioned whether the benefits of Invokana still outweigh its multitude of severe and life-threatening risks. Invokana currently has a Black Box Warning for amputation of the lower extremities (leg, foot, and toe) and for lactic acidosis, a life-threatening condition. Black Box warnings are the most severe warning issued by the FDA. Invokana also puts patients at risk of developing the severe genital infection known commonly as Fournier's gangrene.

FDA Invokana Limb Amputation Warning

In 2016, FDA announced a new Black Box warning for limb amputation from Invokana. Clinical research revealed that Invokana doubles the likelihood of limb amputation. Invokana limb amputation affects the lower extremities including the toes, feet, and legs:

Amputations mainly involve removal of the toe or part of the foot; however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body.

Medical researchers believe Invokana limb amputation is caused by the dehydrating nature of Invokana, which balances the blood sugar by releasing excess sugar through increased urination. Dehydration combined with an inactive lifestyle lead to inadequate blood supply to the legs. Though in the U.S. there is only an FDA Invokana limb amputation warning, several other diabetes drugs in the same class (known as SGLTs inhibitors), including Farxiga and Jardiance, were also found to heighten the risk for limb amputations, according to a European Medicines Agency warning.

FDA Invokana Infection Warning

Thirteen different diabetes drugs have been connected with a risk for severe genital infections, including Invokana, according to an FDA diabetes infection warning issued in August of 2018. The diabetes drug infection, which is commonly known as Fournier's gangrene, is an extremely rare, flesh-eating genital infection that destroys any tissues it comes into contact with. Infecting the tissues in and around the genital area, Fournier's gangrene from diabetes drugs can cause permanent damage:

Fournier's gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. The bacteria usually get into the body through a cut or break in the skin, where they quickly spread and destroy the tissue they infect…. Fournier's gangrene developed within several months of the patients starting an SGLT2 inhibitor and the drug was stopped in most cases. All 12 patients were hospitalized and required surgery. Some patients required multiple disfiguring surgeries, some developed complications, and one patient died.

The FDA diabetes drug infection warning applies to canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin, including Invokana, Invokamet, Invokamet XR, Farxiga, Xigduo XR, Qtern, Jardiance, Glyxambi, Synjardy, Synjardy XR, Steglatro, Segluromet, and Stelujan.

FDA Victoza Pancreatic Cancer Warning

The FDA Victoza pancreatic cancer warning was issued in 2013 after Victoza had already been on the market for three years, but safety experts questioned the wisdom of using Victoza from the very beginning. Victoza is an incretin mimetic, a type of diabetes drug that control blood sugar levels by stimulating the pancreas. FDA advisors cautioned that the drug could result in pancreas problems, and the drug was ultimately only approved with a requirement that Victoza pancreas cancer and other pancreas problems be more fully investigated.

A 2013 study published in JAMA which confirmed a link between Victoza and pancreas precancerous cell growth, triggered the FDA Victoza pancreatic cancer warning. But despite this warning, many consumers remained unaware of the connection between Victoza and pancreatic cancer. This problem is related to a 2017 DOJ lawsuit, in which Novo Nordisk was fined more than $58 million for violating federal law, using illegal marketing tactics to downplay Victoza dangers and promote the drug to doctors. All too often, fines for illegal marketing are seen as the cost of doing business. For Victoza, a $58 million dollar fine to obscure the FDA Victoza warning was a small tradeoff for annual sales of $2 billion. To date, the term “pancreatic cancer” is not included on the drug's warning label.

Previous FDA Diabetes Drug Recalls and Warnings

FDA Diabetes Drug Warnings for Bladder Cancer: Two subsequent FDA Actos bladder cancer warnings were issued, in 2010 and 2011 and resulted in major litigation against Takeda Pharmaceuticals.

FDA Diabetes Drug Warnings for Heart Attack and Cardiovascular Problems: The threat of heart attack and other cardiovascular problems earned the popular diabetes drug Avandia an FDA Warning in the form of a Black Box Warning in 2007. Black Box warnings are the most severe level of FDA drug warning. In 2010, the FDA released a major study on heart attack from diabetes drugs. The patent for Avandia expired in 2012.

FDA Ketoacidosis Warnings for Diabetes Drugs: Two diabetes drug warning were issued in 2015, linking Invokana to an increased risk for kidney problems and ketoacidosis. This class of drugs removes excess blood sugar through the urine stream, taxing the kidneys. The European health agency extended this warning to other similar drugs such as Victoza, Farxiga, Xigduo.

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