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Janumet

The Janumet injury case attorneys at the Drug Law Center are currently evaluating injury cases where patients have suffered harm after taking the antidiabetic medication.

Introduction

Janumet Drug RecallJanumet is a popular oral prescription drug that helps to lower blood sugar levels in adults suffering with type II diabetes. It is highly effective when used adjunct of lay with exercise and healthy diet. The popular medication is a combination of both metformin and sitagliptin, where the first ingredient decreases sugar (glucose) production in the liver while the decreases glucose absorbed in the intestines. Sitagliptin is an anti-hyperglycemic dipeptidyl peptidase-4 inhibitor class medication.

While the drug has been proven to be highly effective, clinical trials have revealed the product can cause serious side effects including headaches, respiratory tract infections, elevated liver enzymes and kidney problems.

The History of Janumet

Janumet (metformin/sitagliptin) received approval by the Food and Drug Administration (FDA) in October 2006 for the treatment of controlling glycemic levels in individual suffering with type II diabetes mellitus. The medication is manufactured, marketed, and sold by Merck & Company, Inc. who initially synthesized the phosphate salt sitagliptin to be combined with metformin. Since its release and the medical marketplace, the FDA has issued numerous warnings after the potential risks of developing pancreatic cancer and pancreatitis was first discovered in patients taking the DPP-4 inhibitors.

Who Should Avoid Taking Janumet?

Because of the serious side effects any medication can produce, there is a certain number of individuals should avoid taking Janumet (metformin/sitagliptin) or any of the components used to make the medication. This includes individual suffering with diabetic ketoacidosis, chronic or acute metabolic acidosis and those with a history of hypersensitivity reaction to metformin and sitagliptin that are used to formulate Janumet. This includes individuals that have angioedema and anaphylaxis reactions.

Every patient should have a discussion with their doctor before taking Janumet if they have any of the following conditions are problems:

  • Liver issue
  • Heart attack
  • Decreased adrenal gland function
  • Sepsis syndrome
  • Severe diarrhea or vomiting
  • Habitual alcohol consumption
  • Acute pancreatic inflammation
  • Suddenly serious heart failure symptoms
  • Pituitary hormone deficiency
  • Insufficient vitamin B12 levels
  • Recent operation
  • Extreme body water loss
  • Weakening condition
  • Kidney impairment
  • Alcohol Intoxication
  • Low blood sugar
  • Infection
  • Injury

Any individual with a history of severe renal impairment or those who are highly sensitive to Metformin hydrochloride should avoid taking Janumet or any formulated medicine containing metformin or sitagliptin.

Janumet Side Effects

All OTC (over-the-counter) drugs and prescription medications have some form of mild to severe side effects, including Janumet (metformin/sitagliptin). The most common mild Janumet side effects include:

  • Diarrhea
  • Vomiting and nausea
  • Headaches
  • Weakness
  • Indigestion, upset stomach, and/or gas
  • Hypoglycemia (low blood sugar levels) especially when Janumet is used with insulin or sulfonylurea
  • Upper respiratory infection
  • Sore throat, running/stuffy nose

The more serious Janumet side effects that can occur in individuals taking the antidiabetic medication include:

  • Lactic acidosis
  • Loss of consciousness
  • Unexpected weakness or tiredness
  • Cloudy thinking
  • Fast heart rate
  • Depression
  • Confusion
  • Cold sweats
  • Blurry vision
  • Slurred speech
  • Stomach or abdominal discomfort
  • Cramping or muscle pain
  • Shallow, fast breathing
  • Decreased appetite
  • Sleepiness
  • Severe skin reaction
  • Less than normal urination
  • Pancreatitis that often involves fast heart rate, vomiting, nausea, and severe pain that reaches to the back from the upper stomach

This is only a partial list of all known side effects and adverse reactions. Patients taking the medication who have any unusual symptoms or sensation should seek out immediate medical advice.

Janumet and the FDA

  • August 2016 – The FDA (Food and Drug Administration) issued a warning involving Type II diabetes drugs that contained sitagliptin, alogliptin, linagliptin, and saxagliptin, including Janumet. The FDA announced that these medications may cause disabling and severe joint pain. The federal agency recommends that all patients taking the DPP-4 (dipeptidyl peptidase-4 inhibitor) medication discontinue taking the drug immediately at the first sign of any persistent severe joint pain.
  • August 2015 – A warning by the FDA is issued to consumers claiming that Janumet might produce debilitating, severe joint pain.
  • August 2013 – More than 50 Janumet injury lawsuits are consolidated into a single multidistrict litigation case in the US District Court for the Southern District of California. Many of the plaintiffs involved and filed a wrongful death or personal injury case after they are loved one suffered life-threatening pancreatic cancer.
  • September 2009 – The Food and Drug Administration revised prescribing data on Janumet (metformin/sitagliptin) to ensure the warning label included necessary information of the correlation of patients taking the drug and the development of acute pancreatitis. Between October 2006 and February 2009, the federal agency received 88 reports of individuals using sitagliptin and the development of hemorrhagic (hemorrhaging) or necrotizing (tissue cell death) pancreatitis. Because of that, the FDA issued a warning to the manufacturers of the medication to revise the data provided on their warning labels to include:
    • Reports of acute pancreatitis including the severe forms, hemorrhagic and necrotizing pancreatitis.
    • Recommendations that doctors monitor their patients carefully “for the development of pancreatitis after initiation or dosage increases of sitagliptin or sitagliptin/metformin, and to discontinue [these drugs] when pancreatitis is suspected while using these products.”
    • Warn consumers that sitagliptin has not been studied in patients with a history of pancreatitis [… and] these patients are at an increased risk of developing pancreatitis while using” these drugs…

    Even with the strict warning by the FDA told the consumer to stop the drug immediately, the agency also said, “Do not stop or change medicines that have been prescribed without first talking with the knowledgeable health care professional.”

The Food and Drug Administration believes that there may be an association between taking these drugs and the development of serious side effects. The agency also noted that “because acute pancreatitis is associated with considerable morbidity [acquiring the condition] and mortality [death], and early recognition is important in reducing adverse health outcomes, FDA is recommending revisions to the prescribing information to alert healthcare professionals to this potentially serious adverse drug event.”

Janumet Recall Information

The popular antidiabetic medication Janumet has assisted many patients and managing the chronic conditions associated with their Type II diabetes health problems. However, there have been significant problems with many patients who have suffered serious side effects. Even so, the FDA has not issued of mandatory recall, nor have the drug manufacturers voluntarily recalled the medication from the medical marketplace, even though there has been a linked association of taking the drug in the increased potential risk of developing a variety of conditions including kidney failure, pancreatic cancer, thyroid cancer, and acute, hemorrhagic, and necrotizing pancreatitis.

Lawsuits

Many patients have suffered serious side effects of taking Janumet, and have been diagnosed with pancreatitis her pancreatic cancer typically have legal opportunities to seek financial recompense from Merck & Co., makers of the antidiabetic medication. In 2013, federal judges decided to consolidate numerous cases filed in federal court into a single multidistrict litigation case to save money and time and provide easy access to common resources for plaintiffs and defendants participating in similar types of lawsuits.

In addition, consolidation helps to ensure that rulings remain consistent and provides the opportunity for attorneys on both sides of the case to understand how similar juries will react when hearing evidence shared by all parties in dozens of cases. By the following year (2014) more than 300 cases were pending against pharmaceutical companies that made and sold Janumet and other products containing metformin and sitagliptin.

Janumet Lawsuits

  • Janumet Wrongful Death Lawsuit Filed by Kentucky Woman’s FamilyAugust 2014 – Merck & Company is facing another Janumet wrongful death lawsuit, this time filed by the surviving family members of a Kentucky woman who died of cancer after allegedly taking the popular drug to treat her Type II diabetes. Wrongful death lawsuit documents reveals that the woman was prescribed Janumet in 2010 dealt regulate her blood sugar levels. The following year her doctors diagnosed her with pancreatic cancer. She succumbed to the disease in 2012.

    Lawyers working on behalf of the plaintiffs in the case are alleging the patient could not make an informed decision because Merck & Co. concealed the correlation between taking the medication and the development of pancreatic cancer. The lawsuit is based on the drug manufacturers your responsibility and their failure to warn the patient, or doctor in the medical community of the potentially dangerous side effects of Janumet. The surviving family members are seeking compensation claiming that Merck & Co. was negligent, concealed information, falsely advertised the product, and misrepresented its side effects.

  • Janumet Pancreatic Cancer Lawsuit Filed by a California CoupleJuly 2014 – Another Janumet lawsuit has been filed, this time by a California couple after the husband was diagnosed with terminal cancer allegedly from using the diabetic medication. The lawsuit document reveals that doctors prescribe Janumet to the San Raphael California plaintiff in April 2010 to control his blood sugar levels associated with Type II diabetes. The plaintiff took the medication according to instructions by his doctor and directions by Merck & Co., manufacturers of Janumet, until September 2010, on the day his doctors diagnosed with pancreatic cancer.

    Attorneys working on the California couple’s behalf has built a compensation claim on allegations that the husband had no potential risk of ever developing pancreatic cancer. It was only after he began taking Janumet that cancer began developing. His lawyers state that he was unaware of the associated risks of taking Janumet and that Merck failed to warn him through the product’s warning labels.

    The plaintiff states that had he known he would have chosen another method of treatment. He and his wife are seeking compensation from Merck & Co. through allegations of a failure to warn, breach of warranty, strict liability, negligence, loss of consortium, and punitive damages.

Can I Receive Compensation for Janumet-Associated Injuries?

The defective medication and product liability litigation attorneys working at the Drug Law Center represent plaintiffs who have suffered serious injuries including pancreatic cancer after taking Janumet. We are currently handling class action litigation cases and individual lawsuits to ensure our clients receive the highest level of financial compensation available.

If you suffered injury, or lost a loved one, after they took Janumet and suffered serious injuries including pancreatitis or pancreatic cancer, contact us today. You are more than likely entitled to receive monetary compensation. Let us begin the process of filing and handling every aspect of your case. To minimize the financial burden on you and your family, our legal team is currently accepting Janumet injury lawsuits through contingency fee agreements. This means we will postpone payment of all our legal services until after we have successfully negotiated your settlement or won your case at trial. If we do not get you money, you oh was nothing.

To discuss the merits of your case, contact us today to speak with one of our attorneys during a no obligation, free case evaluation. The personal details and private case information you share with us will remain confidential.

Sources:

http://jamanetwork.com/journals/jama/article-abstract/2612613

https://www.fda.gov/downloads/drugs/drugsafety/ucm204268.pdf

https://my.clevelandclinic.org/health/articles/oral-diabetes-medications

https://www.fda.gov/downloads/drugs/drugsafety/ucm204268.pdf