Saxenda Dose Contains Twice As Much Liraglutide As Diabetes Medicine Victoza, Also Linked To Malignancy In Pancreas
In 2014, the FDA approved Saxenda (liraglutide) for the treatment of obesity. Novo Nordisk is the responsible pharmaceutical company.
Liraglutide, the active ingredient for Saxenda, is a glucagonlike peptide-1 (GLP-1) receptor agonist. More generally, Saxenda is in the incretin mimetic class of drugs.
Four years earlier, the FDA approved another liraglutide-containing medicine, Victoza, which is a popular Type-2 diabetes drug.
Like Victoza, Saxenda has been associated with an increased risk of pancreatic cancer, or pancreas cancer, in patients using this still relatively new obesity, or weight-loss, drug.
However, the alarming difference between Saxenda and Victoza is that the standard dose of Saxenda for obesity contains 3.0 mg of liraglutide, while the standard doses of Victoza for diabetes are 1.2 mg or 1.8 mg of liraglutide. So the patient using Saxenda is getting about two-times more liraglutide than the patient using Victoza.
While the current Prescribing Information, or drug label, for Saxenda (accessed 1/30/18) has a so-called "Black-Box Warning" for the risk of thyroid C-cell tumors, a type of thyroid cancer, and pancreatitis is mentioned in the Warnings and Precautions section, there is nothing about an increased risk of pancreatic cancer.
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In this April 2015 news article, "After 13 years of wariness, FDA approves five potentially harmful new diet drugs", by medical reporters John Fauber, Coulter Jones and Kristina Fiore, the pancreatic cancer side effect of Saxenda and Victoza was examined:
Consider liraglutide, an injectable drug that works in part by helping the pancreas produce more insulin. The drug also suppresses appetite by fooling the brain into thinking the stomach is full.
Liraglutide is the generic name for Saxenda, which was approved for obesity in December. It is merely a higher dose of Victoza, a drug that has been marketed since 2010 for type 2 diabetes.
As a diabetes drug, Victoza was the primary suspect in 348 deaths and more than 3,100 hospitalizations through June 2014, according to the most recently available FDA data. At least 100 of those reported deaths were linked to pancreatic cancer....
With the approval of higher-dose Saxenda, the FDA doubled down on its confidence in the drug's safety. It has a 3-mg daily dose, compared with 1.2 mg or 1.8 mg for Victoza.
The labels for both drugs also warn patients to stop using the drugs promptly if pancreatitis is suspected.
That's what Tom LaRosa did last August when a blood test showed possible inflammation of his pancreas, said his wife, Sandy. The test was done because he had been having stomach problems, which can be a warning sign of pancreatic cancer.
LaRosa, 72, had been using the 1.8 mg dose of Victoza since 2010 to control his blood sugar with the hope it would also help him lose weight....
Despite stopping the use of Victoza in August, LaRosa's stomach problems got worse.
On Thanksgiving Day, the stomach pain was so severe that he went to the hospital. After a CT scan, he was diagnosed with pancreatic cancer.
He died in January.
Sandy LaRosa said her husband was never told that Victoza might increase his risk of pancreatic cancer. His doctor, Bradley Javorsky, MD, said he did tell LaRosa about the risks of pancreatitis and pancreatic cancer risk.
"I have that discussion with everybody," said Javorsky, an endocrinology and diabetes specialist and assistant professor with the Medical College of Wisconsin.
As stated above, today there is nothing about an increased risk of pancreatic cancer in the drug label for Saxenda, nor is there any such warning in the current Prescribing Information for Victoza (accessed 1/30/18).
While Dr. Javorsky may have talked with his patients about the pancreatic cancer risk of liraglutide back then, since there is no warning about pancreas cancer in either the current Saxenda or Victoza drug labels, it is unlikely that many doctors are having this discussion with their patients even today.
We are currently investigating pancreatic cancer cases involving Saxenda -- as well as Victoza and other incretin mimetic diabetes drugs such as Byetta, Bydureon, Januvia, and Janumet -- as drug injury lawsuits filed against the responsible pharmaceutical company based on this failure to warn about the increased risk of pancreatic cancer.
DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects (All website content by attorney Tom Lamb)
Drug Injury Case Evaluation - Free. Confidential. No Obligation. (Case review done by attorney Tom Lamb)