Victoza (liraglutide) is a diabetes drug that stimulates the pancreas to secrete extra insulin. One potential side effect of this medication is kidney failure.
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Victoza (liraglutide) is a treatment for complications of Type-2 diabetes. It was invented by the Danish pharmaceutical company Novo Nordisk, and it was approved by the U.S. FDA in early 2010. Victoza has quickly become one of the most popular anti-diabetes drugs, with almost 2 million prescriptions.
FDA Experts Recommend Against Approving Victoza
When Victoza was approved, three safety experts (two pharmacologists and one safety reviewer) employed by the FDA to review Victoza recommended against approving this drug. One experts, Dr. Karen Mahoney, wrote:
“The clinical safety reviewer does not recommend approval of liraglutide at this time … In the United States, there are already 11 classes of drugs approved for glycemic control in type 2 diabetes … The need for new therapies for Type-2 diabetes is not so urgent that one must tolerate a significant degree of uncertainty regarding serious risk concerns.”
The “significant degree of uncertainty” likely refers to the fact that Victoza is a relatively new drug with a short safety history. It often takes several years for major safety problems to emerge. People must take the drug, develop the disease, report their disease to the FDA, and researchers must review this information and decide whether to issue a safety warning or update the label on the drug. When there is uncertainty, it can take many years before large post-marketing studies are completed.
Victoza and Kidney Failure
Since Victoza was approved, more and more people have reported severe side effects, including Victoza kidney failure. In response, the FDA forced Novo Nordisk to update the warning information on Victoza to warn of the risk of kidney failure (also known as “renal failure”). The new labels inform patients about the risk of “acute renal failure and worsening of chronic renal failure.”
The drug information also reads:
“Victoza® may cause nausea, vomiting, or diarrhea leading to dehydration, which may cause kidney failure. This can happen in people who have never had kidney problems before.”
What is kidney failure? Also referred to as “renal failure” or “renal insufficiency,” this serious, life-threatening medical condition occurs when the kidneys are unable to remove toxins, waste products, salts, and excess fluid from the blood. This failure to cleanse the blood causes these substances to accumulate to dangerously high levels over several hours or days. In severe cases, people with kidney failure may need dialysis, which is a machine that takes a person’s blood, filters it, and replaces the blood in the patient’s body.
Advocacy Group Calls for Victoza to be Banned Immediately
April 19, 2012: The watchdog consumer advocacy organization Public Citizen is calling for an immediate ban of Victoza in the U.S. The group cites numerous safety concerns with the drug, including:
- Patients taking Victoza may develop kidney failure
- Early studies of Victoza showed a 3.7-fold increased risk of acute pancreatitis
Symptoms of Victoza Kidney Failure
Victoza kidney failure symptoms may appear suddenly (acute kidney failure) or gradually worsen over time (chronic kidney failure). Symptoms may include:
- Decreased output of urine, which may be intermittent
- Retaining fluid (swelling of the feet, ankles, or legs)
- Changes in consciousness (drowsiness, dizziness, fainting, comatose)
- Shortness of breath
- Changes in cognition (confusion)
- Chest pain, pressure, discomfort
Do I have a Victoza Kidney Failure Lawsuit?
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