Victoza Side Effects
Common side effects of the Type 2 diabetes drug Victoza include nausea, diarrhea and vomiting. Nausea was the most reported side effect in clinical trials and in postmarketing reports submitted to the U.S. Food and Drug Administration. Studies also link the drug to serious problems such as pancreatitis and gallbladder disease.
Victoza (liraglutide injection) is a once-a-day injectable medication for Type 2 diabetes. The most common side effects of the drug are gastrointestinal problems such as nausea, vomiting and diarrhea. In clinical trials, these reactions occurred in 5 percent or more of patients who took the drug.
- Decreased appetite
- Dyspepsia (digestive problems)
- Upper respiratory tract infection
- Back pain
- Injection site reactions
In addition to common side effects, Victoza’s medication label warns about a few serious side effects. People with existing kidney problems who take the medication may experience worsening of their condition. The drug may increase the risk of pancreatitis and gallbladder disease. It also carries a black box warning — the FDA’s most serious warning — for the risk of thyroid cancer.
According to the U.S. Food and Drug Administration’s Adverse Events Reporting System (FAERS), there were 25,613 reports of adverse events associated with the medication from 2010 to Sept. 30, 2018. This included 8,550 serious cases, and 747 of those were deaths.
FAERS data is postmarketing data which means it comes from real-world clinical practice as opposed to clinical trials, where researchers carefully select patients to receive a drug.
Because FAERS is voluntary reporting, researchers say side effects are underreported. But it also means there is no way to verify that a drug actually caused the side effect. In the case of Victoza, the most reported side effect in clinical trials — nausea — is also the most reported side effect in FAERS.
The medication may have one desirable side effect for Type 2 diabetes patients: weight loss. According to a January 2018 case report by Noe Quesada-Vasquez and colleagues, people take in fewer calories because the drug decreases appetite and this may lead to weight loss.
Risk of Pancreatitis
In March 2013, an FDA Drug Safety Communication warned that several Type 2 diabetes drugs including Victoza may increase the risk of pancreatitis. The FDA also flagged some data that may link the drug to pancreatic cancer.
Lawsuits over Victoza say the drug’s faulty formulation increased the chances of developing pancreatic cancer, and the drug’s manufacturer failed to adequately warn of the risk. The drug’s prescribing information does not include information on pancreatic cancer.
Though pancreatitis is a rare side effect of the medicine, the FDA still requires a warning on the drug’s medication insert. Some studies made a connection between pancreatitis and Victoza’s active ingredient, liraglutide. Researchers also described some individual cases.
A review published in June 2015 in Diabetes Care looked at clinical trial data and other studies on liraglutide and pancreatitis. Researchers found more people on liraglutide suffered pancreatitis than people who took other diabetes drugs. People who took liraglutide had 2.1 times the risk while people who took other diabetes drugs had 1.7 times the risk.
An earlier paper published in 2011 in the International Journal of Clinical Pharmacology reviewed eight clinical studies and found six cases of pancreatitis and five cases of cancer in patients who took liraglutide.
More recently, in the 2018 case report by Quesada-Vazquez and colleagues, researchers reported the case of a 44-year-old woman who had abdominal pain with nausea and vomiting. They examined her and determined she had pancreatitis from taking liraglutide.
Doctors admitted her to the hospital, discontinued the drug, and gave her intravenous fluids and painkillers. After four day
Victoza has a black box warning for the risk of thyroid c-cell tumors. These may lead to medullary thyroid carcinoma (MTC), a rare and difficult-to-treat type of thyroid cancer.
The drugmaker placed the warning on the medication based on animal studies that showed mice exposed to liraglutide developed tumors, and researchers don’t actually know how this will affect humans.
But from 2010 to Sept. 30, 2018, FAERS received close to 200 reports of Victoza users who developed various thyroid cancers, including 22 cases of MTC that included one death.
Dr. Michael A. Nauck and Nele Friedrich studied the connection between liraglutide and thyroid cancer and published their findings in Diabetes Care in August 2013. Some mice and rats given injections of liraglutide had increased c-cell abnormalities that led to tumors.
Researchers said human c-cells may not respond the same way. They looked at studies where humans received liraglutide for up to 52 weeks with doses ranging from 1.8 mg to 3 mg daily, and there was no indication that c-cells changed.
Still, authors could not say for sure whether liraglutide did not cause thyroid cancer. They urged caution in people with a higher risk for thyroid cancer.
“The one consequence to be drawn from these considerations is not to treat subjects at high risk for developing medullary thyroid carcinoma based on multiple endocrine neoplasia or familial medullary thyroid carcinoma with liraglutide (according the label), and it is advisable to practice caution with other incretin-based medications as well,” Nauck and Friedrich wrote.
Victoza’s drug label warns that clinical trials found some patients who took the drug suffered acute gallbladder disease. Most of these people required hospitalization and/or gallbladder removal.
According to the clinical trial data, 3.1 percent of the 4,666 patients who took Victoza suffered gallbladder disease compared to 1.9 percent of the 4,672 placebo-treated patients.
Researchers have theories about how the medication may affect the gallbladder. A 2018 study in Diabetes, Obesity and Metabolism showed liraglutide slowed the process of bile leaving the gallbladder. If the bile builds up in the gallbladder, it can cause inflammation and infection, a condition known as cholecystitis.
Another study in the same journal by Dr. Mark M. Smits and colleagues found liraglutide could increase gallstone production.
A 2017 RxFiles Trial Summary of the Liraglutide: Cardiovascular (CV) Outcomes and Mortality in Patients with Type 2 Diabetes (T2DM) (LEADER) trial found there will be one extra case of gallbladder disease for every 100 patients who use Victoza.
Authors Rebecca Stan and colleagues said the LEADER trial was the largest and longest trial for liraglutide to date, but that it had weaknesses and may have left out data. People who dropped out of the trial because of severe adverse events were “censored,” so trial researchers could have missed important side effects. Also, Novo Nordisk, Victoza’s manufacturer, funded the trial, and it only lasted 3.5 to 5 years.
Please seek the advice of a medical professional before making health care decisions.