Does Saxenda have a black box warning?

Like Victoza, Saxenda comes with a so-called “Black Box” warning label – the FDA's highest level warning. The label warns about the risk of thyroid cancer and a potential risk of acute pancreatitis. However, there is no specific mention of an increased risk of pancreatic cancer.

millerandzois.com - Saxenda Cancer Lawsuits | Liraglutide and Pancreatic Cancer

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This page is about the cancer risks of Saxenda (liraglutide). The concern with Saxenda is pancreatic cancer. Saxenda lawsuits were filed some years ago alleging the diet drug causes pancreatic cancer. This page was updated in January 2023.

Saxenda Cancer Risks

Saxenda (Liraglutide) is a new prescription weight loss drug for the treatment of clinical obesity. Saxenda is manufactured by Novo Nordisk. The active ingredient in Saxenda is Liraglutide. Liraglutide works by imitating the effects of glucagon-like peptide (“GLP-1”), a hormone produced in the intestines that signal to the brain when you are full. The drug essentially suppresses appetite by tricking the brain. It seems to work for some patients to combat obesity. Liraglutide has been approved since 2010 for use in the treatment of diabetes under the brand name Victoza. Victoza has already been tagged as a potential cause of pancreatic cancer. According to reports published by the FDA, Victoza was a suspected cause of more than 300 deaths and over 3,000 hospital visits between 2010 and 2014. Around one-third of those fatalities were the result of pancreatic cancer. Hundreds of Victoza lawsuits have already been filed. It makes sense Victoza would go first because it is an older drug. But, if you believe the science that plaintiffs’ lawyers tried to adopt, Saxenda could cause a greater cancer risk because it contains a much higher dose of Liraglutide than Victoza. This drove interest in Saxenda cancer lawsuits. But conclusive scientific proof did not follow.

Growing Concerns Regarding Saxenda and Other Incretin Drugs

The active ingredient in Saxenda and Victoza (Liraglutide) is part of the “incretin” family of drugs. Incretin drugs fall into 2 categories: (1) GLP-1 agonists such as Saxenda and Victoza; and (2) DPP-4 inhibitors like Januvia. What all incretin drugs have in common is that they manipulate GLP-1 hormone levels in the body. The underlying problem with incretin drugs is that they are known to cause abnormal cell growth in the pancreas. Since incretin drugs first came on the market there has been concern that the effect of these drugs on the pancreas may cause pancreatic cancer. But, as we discuss below, this link has not been scientifically established, at least not yet. Saxenda belongs to a class of medications called DPP-4 inhibitors. Exenatide and liraglutide belong to a class of medications referred to as GLP-1 receptor agonists. These two classes of medication, DPP-4 inhibitors, and GLP-1 receptor agonists are called incretin-based therapies because incretin hormones lower blood sugar by stimulating or sustaining the production of insulin The first incretin drugs were approved by the FDA in 2005 for the treatment of diabetes. By 2007 the FDA had received numerous reports that these drugs were causing pancreatitis (inflammation of the pancreas).

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This prompted the FDA to publish an alert warning that incretin drugs may increase the risk of acute pancreatitis. The FDA also required drug manufacturers to include this information in their product information and warnings. The next round of incretin drug approvals resulted in a similar wave of reports regarding pancreatitis. In 2009 a study of incretin drugs was conducted on animals. The results of the study indicated that increased GLP-1 levels were a probable cause of pancreatic and thyroid cancer in rodents. Researchers at UCLA Medical School later conducted a study that autopsied individuals who had been taking incretin drugs. The autopsy results showed cell abnormalities in the pancreases of ALL of the individuals who had been taking incretin drugs for one year or more. In addition to abnormal cell counts, small tumors were noted in the pancreases of the individuals taking incretin drugs. The cell abnormalities and tumors are indications that these individuals may have developed pancreatitis (an inflamed pancreas) or pancreatic cancer in the future. In 2011 a study was published in the Journal of Gastroenterology on the incretin drug Byetta. The study found that individuals on Byetta were 3 times more likely to get pancreatic cancer. In 2013 a study conducted by Johns Hopkins found that incretin drugs double the risk of acute pancreatitis and that individuals taking the drugs had a higher rate of pancreatic masses and precancerous tumors. A few months later a European study also concluded that there was an association between incretin drugs and pancreatic damage. In 2012 the FDA received (and later rejected) a Citizen Petition formally requesting that Saxenda’s sister drug, Victoza, be taken off the market based on evidence of an increased risk of pancreatic cancer. In response, the FDA issued a Drug Safety Communication in March 2013 regarding incretin drugs and pancreatic cancer risks. The FDA then investigated the association between pancreatic cancer and incretin drugs. In March 2014 the FDA announced that there was no conclusive evidence to show a causal link between Victoza and pancreatic cancer. A few months later the FDA reviewed safety concerns regarding Saxenda and reached the same conclusion. In 2017 the results of a new European study were presented to the European Cancer Organization. This study concluded that individuals taking incretin drugs for diabetes were at a significantly increased risk of developing pancreatic cancer. But this study has not been meaningfully replicated. This 2021 study again raises the concern of a link between Saxenda and pancreatic cancer. But the results are far from conclusive.

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But… this 2021 study suggests the exact opposite

Saxenda Litigation

Victoza has been around a few years longer, however, was the subject of numerous cancer injury lawsuits. Saxenda and Victoza contain the same active ingredient (Liraglutide) but Saxenda is a much higher dosage so it presumably presents the same if not greater safety risks. The Victoza lawsuits were based on failure to warn against allegations. Specifically, that Novo Nordisk failed to warn doctors and patients that Victoza increased the risk of pancreatic cancer. Like Victoza, Saxenda comes with a so-called “Black Box” warning label – the FDA’s highest level warning. The label warns about the risk of thyroid cancer and a potential risk of acute pancreatitis. However, there is no specific mention of an increased risk of pancreatic cancer.

Does Saxenda Cause Pancreatic Cancer?

No one knows if Saxenda causes pancreatic cancer. The FDA has said that “animal, observational, and clinical trial data” does not support a causal association between Saxenda and pancreatic cancer. So the FDA has specifically looked at it and determined there is no association. Is that conclusive on the issue of whether Saxenda can cause pancreatic cancer? It is not. The FDA has made mistakes on the relationship between drugs and diseases an estimated 10 zillion times. But Saxenda lawsuits will not go anywhere unless there is scientific proof that Saxenda causes pancreatic cancer. Ultimately, it is depressing what we do not know about the side effects of so many drugs, including Saxenda. It is not a stretch that Saxenda causes pancreatic cancer because we suspect it causes thyroid cancer and acute pancreatitis. But we do not even know that. All we know is that the drug causes thyroid cancer in animals. Does that translate to humans? We do not know if Saxenda causes any cancer, much less pancreatic cancer.

Our lawyers are not handling these claims.

millerandzois.com - Saxenda Cancer Lawsuits | Liraglutide and Pancreatic Cancer

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