It acts by binding to the same receptors as does the endogenous metabolic hormone GLP-1 that stimulates insulin secretion. It mimics the GLP-1 (glucagon-like peptide-1) hormone and controls the blood glucose level when given along with diet and exercise, in adult patients with Type 2 diabetes mellitus. The injectable form works by stimulating insulin production.
Victoza is a plain colorless solution and one ml of it comprises 6 mg liraglutide along with inactive ingredients like propylene glycol, disodium phosphate dehydrates, phenol, and water. A pre-filled pen comes along with a 3 ml Victoza solution which accounts for 18 mg of liraglutide.
This injectable prescription helps decrease the risk of chronic diseases like heart attack, stroke, and type 2 diabetes. Victoza is not ideal for people with type 1 diabetes. There are still no known facts established which say that Victoza is effective in lowering blood sugar for children below 10 years of age.
Before getting Victoza prescribed, the patient must give health care providers useful information like whether they are suffering or have suffered from pancreas, kidneys, or liver problems. Other information like severe problems with the stomach or whether the patient is breastfeeding or is pregnant or planning to become pregnant should also be shared with the prescriber. Also remember that insulin and Victoza should never be taken together in the same injection. Also, the injection of Victoza and injection of insulin should not be given next to each other on the body part, however, it may be injected on the same body area. The important thing to note is that Victoza should be stopped if a patient starts experiencing severe pain in the abdomen, also if Victoza is used with other medication like sulfonylurea, the risk of hypoglycemia development will increase tremendously.
Victoza is a plain colorless solution and one ml of this drug comprises 6 mg liraglutide along with inactive ingredients like propylene glycol, disodium phosphate dehydrates, phenol, and water. A pre-filled pen comes along with a 3 ml Victoza solution which accounts for 18 mg of liraglutide.
This injectable prescription helps decrease the risk of chronic diseases like heart attack, stroke, and type 2 diabetes. Victoza is not ideal for people with type 1 diabetes. There are still no known facts established which say that Victoza is effective in lowering blood sugar for children below 10 years of age.
Before getting Victoza prescribed, the patient must give health care providers useful information like whether they are suffering or have suffered from pancreas, kidneys, or liver problems. Other information like severe problems with the stomach or whether the patient is breastfeeding or is pregnant or planning to become pregnant should also be shared with the prescriber. Also remember, that insulin and Victoza should never be taken together in the same injection. Also, the injection of Victoza and injection of insulin should not be given next to each other on the body part, however, it may be injected on the same body area. The important thing to note is that Victoza should be stopped if a patient starts experiencing severe pain in the abdomen, also if Victoza is used with other medication like sulfonylurea, the risk of hypoglycemia development will increase tremendously.
In May 2013, the U.S. Food and Drug Administration (FDA) released important statements indicating that incretin mimetics drugs like Victoza, Januvia, Janumet, and Byetta can lead to serious complications which can be a pancreatic disease. The agency also alerted the consumer that it is studying the drug's association with pancreatic cancer.
Lawsuits have been filed by the people who have suffered injuries from side effects of Victoza. Novo Nordisk is the manufacturer of Victoza who has been accused of not testing their product properly and failed to warn about the risk associated with consumers.
In August 2013, 53 cases against Novo Nordisk got transferred by the Judicial Panel on Multidistrict Litigation to MDL No. 2452. The cases originated from state courts in Arizona, Colorado, Oklahoma Missouri, Kansas, and Pennsylvania.
The lawsuits filed by plaintiffs have an allegation that Victoza led to pancreatic cancer and pancreatitis. By centralizing the cases in a single MDL, the proceedings for cases will be more efficiently handled and it would also ease the process and save time.
The lawsuits filed by plaintiffs have accused the manufacturer of faulty formulation of Victoza that has increased the risk of pancreatic cancer. Manufacturers of these incretin mimetics drugs also did not attempt to inquire about the safety aspect of their product and completely failed to monitor side effects before selling the drug. Also, the warning label on the drug did not mention 'pancreatic cancer' and presented the consumer with an inadequate warning.
A survey conducted in the year 2011 proved that more than half of physicians were unaware of Victoza's risks. Novo Nordisk ran a deceptive marketing campaign to falsely misled the consumer.
In September 2017, Victoza manufacturer made a settlement of $58.7 million with the Department of Justice. This included $12.5 million allocated for claim settlement brought against Novo Nordisk for violating the Food, Drug and Cosmetic Act, and the other $46.5 million was assigned for whistleblower claims settlement.
If the patient has been diagnosed with pancreatic cancer after 2005 due to Victoza or if anyone has lost their loved ones due to the side effects of this incretin mimetics drugs can file a lawsuit. The lawsuit can help recover lost earnings, pain and suffering, and medical bills.
Serious Alleged Injuries May Include:
- Hypoglycemia
- Kidney Failure
- Severe Allergic Reaction
- Pancreatitis
- Pancreatic Cancer
- Thyroid Cancer
FDA Safety Warnings:
On June 14, 2011, the warning had been issued by the FDA for Victoza about the risks of thyroid cancer and pancreatitis. The agency also highlighted the contraindication for liraglutide in patients with a personal or family history of medullary thyroid cancer or a personal history of multiple endocrine neoplasia syndrome type 2.
On April 9, 2012, the FDA approved updating the label regarding the superior blood glucose control when compared to Januvia.
In April 2013, warnings and precautions included acute pancreatitis, fatal and non-fatal hemorrhagic and necrotizing pancreatitis.
In March 2015, black box warning and precautions were modified, adding the risk of thyroid C- cell tumors, including medullary thyroid carcinoma (MTC).
Legal Updates:
Defendants: Merck Sharp & Dohme Corp., Eli Lilly & Co., Novo Nordisk Inc., and Amylin Pharmaceuticals LLC.
Defendant Law Firm: Kannon K. Shanmugam of Williams & Connolly LLP.
Allegations: Allegations include that the manufacturers failed to warn consumers about pancreas problems and other side effects from Type 2 diabetes drugs.
Plaintiff Steering Committee:
Lawsuit Status:
- 2013: Victoza side effects along with several diabetes medications (Byetta, Januvia, and Janumet) lawsuits were centralized in a multidistrict litigation MDL 2452 (In Re: Incretin Mimetics Products Liability Litigation) in the Southern District of California. Lawsuits filed alleged that though the manufacturers knew about the link of their product to cancer side effects in several studies, the details were not made public. Victoza thyroid lawsuits were filed across the nation, claiming that the drug caused patients to develop thyroid and pancreatic cancer.
- November 2015: Judge Battaglia, granted summary judgment in favor of the defendants, following a preemption protocol dismissing all the cases in the MDL.
- September 2016: Plaintiff attorneys filed an appeal to the Ninth Circuit U.S. Court of Appeals on behalf of the MDL stating that Judge Battaglia misinterpreted the U.S. Supreme Court preemption law.
- November 2017: The U.S. Court of Appeals for the Ninth Circuit reversed and vacated the Federal District Court Judge's ruling, thereby reinstating the dismissed federal lawsuits and sending them back to the Federal District Court in California for further proceedings.
News
Dec 14, 2017: 100's of Byetta, Victoza, Januvia & Janumet Cases Reinstated
At least 700 Byetta lawsuits, Januvia, Janumet, and Victoza lawsuits, belonging to MDL No. 2452 were reinstated through a federal court appeal made by plaintiffs who allege they developed pancreatic cancer following the use of the diabetes drugs made by these manufacturers.
In November 2015, Judge Battaglia granted a summary judgment in favor of the defendants following a preemption protocol, dismissing all the cases which were a part of MDL No. 2452. Following this, in September 2016, the plaintiff attorneys filed an appeal to the Federal Appeals Court stating that Judge Battaglia misinterpreted the U.S. Supreme Court preemption law, responding to which the court ruled in favor of the plaintiffs. The court also overturned a discovery decision that had denied the plaintiffs' requests for documents from the drug makers stating it was unduly burdensome and also allowed some of the previously denied testimony by one of the plaintiffs' expert witnesses.
The litigation will continue to be presided over by Judge Battaglia for further proceedings. The announcement of bellwether trials is expected soon.
Mar 29, 2018: Hundreds of Incretin Mimetics Lawsuits Reinstated
Nearly 700 lawsuits, all involving antidiabetic drugs Byetta, Victoza, Januvia, and Janumet, were reinstated by the U.S. Court of Appeals for the Ninth Circuit, wherein the previous ruling was overturned. The lawsuits were reinstated and remanded to Judge Battaglia for coordinated pretrial proceedings, which had been paused for about two years after the judge passed a motion for summary judgment filed by the drug makers in 2015, finding that the claims were preempted by federal law.
Allegations include that the drug makers knew that the use of this class of diabetes medications, known as incretin mimetics may result in the development of pancreatic cancer, yet they failed to warn consumers and the medical community.
MDL No. 2452 (In Re: Incretin Mimetics Products Liability Litigation) was created in 2013 in the Southern District of California before U.S. District Judge Anthony Battaglia.
The federal court recently adopted a new schedule as per the case management order (PDF) issued on March 21, wherein Judge Battaglia adopted a discovery schedule proposed by the drug makers for discovery and another round of pretrial motions on general causation and preemption issues before any individual cases will be allowed to go before a jury. Further, the court has set December 11, 2018, as the time limit within which the parties can file challenges to the admissibility of certain expert witnesses and another round of summary judgment motions, to be followed by a selection of a small group of bellwether trials by December 14. According to this new schedule, the first bellwether trial may begin in January 2020.
Nov 9, 2018: California Court Restores Pancreatic Cancer Lawsuits
In an opinion filed on November 6, a California Court of Appeal, 2nd District reinstated product liability cases against a group of drugmakers sued for providing an inadequate warning about the risk of developing pancreatic cancer linked to type-2 diabetes drugs.
The defendants who must face pancreatic cancer lawsuits are Merck Sharp & Dohme Corp, the maker of Janumet and Januvia; Novo Nordisk Inc, the manufacturer of Victoza; and AstraZeneca's Amylin Pharmaceuticals. In November 2015, Judge Battaglia granted a summary judgment in favor of the defendants following a preemption protocol, dismissing all the cases which were a part of MDL 2452. The plaintiff's attorney filed an appeal to the Federal Appeals Court that the Judge misinterpreted the U.S. Supreme Court preemption law, responding to which the court ruled in favor of the plaintiffs.
Januvia, Janumet, Byetta, and Victoza are popular type 2 diabetes drugs that have been reported to cause dangerous side effects like pancreatic cancer and pancreatitis. As of September 2018, 948 cases were pending in the federal MDL presided by Judge Battaglia.
Jan 3, 2019: 900+ lawsuits filed for Victoza, Byetta, Januvia and Janume
More than 900 Victoza, Byetta, Januvia, and Janumet lawsuits are filed in several state and federal courts. The litigation was centralized in 2013 in the Southern District of California for coordinated pretrial proceedings.
According to a December 26 ruling by the Illinois First District Appellate Court, the jury would determine whether the federal regulators would have allowed Merck to include pancreatic cancer warnings to Januvia's labels.
The ruling upholds a previous Cook County Judge's decision in denying summary judgment motion in two Januvia lawsuits which were filed by family members of four plaintiffs who died due to pancreatic cancer while under Januvia treatment. The lawsuits claimed Merck was aware of the risks linked to the diabetes drug and yet failed to send out sufficient warnings to patients and the medical community. Merck refused to take responsibility for failure-to-warn claims, stating that the FDA would not have allowed adding pancreatic cancer risks as a warning label on the drug label and sought summary judgment in 2013. U.S. District Judge Anthony Battaglia granted summary judgment in 2015 and tossed all the filed cases under MDL No. 2452, finding that the claims were preempted by federal law. However, those cases were reinstated last year by a California Court of Appeal, 2nd District. In its opinion, the Illinois Appeals Court told the issue needs to be put before a jury as part of a trial.
Evidence:
- Usage Of Victoza In Pharmacy Records
- Duration Of Victoza Usage
- Indications For Usage Of Victoza In Medical Records
- Complications And Their Treatment After Victoza Intake
Medical Record Review and claim validation of Victoza case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.
