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The U.S. Food and Drug Administration (FDA) first approved the drug Janumet® (sitagliptin/metformin) in 2007. Approved to treat diabetes patients, the drug is a combination of Januvia® (sitagliptin) and metformin.

Both drugs have been linked to an increased risk of acute pancreatitis and hemorrhagic or necrotizing pancreatitis. In fact, the FDA notified healthcare providers and patients of the potential injuries, and updated the prescribing information to include warnings of pancreatitis side effects among users.

If you or someone you love has suffered acute pancreatitis or hemorrhagic pancreatitis after using Januvia® or Janumet®, you may be eligible to seek and recover compensation for your injuries, pain and suffering. For more information, or to speak with an experienced attorney about your specific circumstances, contact our Januvia®/ Janumet® lawyers today.

Januvia® and Janumet® Diabetes Medication

Januvia® and Janumet® are oral drugs to treat Type 2 diabetes. People with Type 2 diabetes do not produce enough insulin to properly control the levels of sugar in their blood. Sitagliptin (the generic of Januvia®) is the first drug to be made in a new class of medications known as selective dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors).

DPP-4 inhibitors work by regulating the levels of insulin that the body produces. Insulin is a hormone that controls the levels of sugar in the blood. Too little insulin allows a rise in the levels of blood sugar.

Difference Between Januvia® and Janumet®

Janumet® is a combination medication that contains two active ingredients, sitagliptin and metformin. Januvia® only contains sitagliptin. Januvia® and Janumet® help the body control its insulin levels and therefore the blood sugar of diabetics, especially after eating, when blood sugar is high, or between meals. The drugs are not for controlling Type 1 diabetes.

Potential Health Risks: FDA Warning

The FDA posted an announcement in September 2009 about Januvia® and Janumet® for healthcare professionals and patients. The announcement said that the FDA was revising the prescribing information of Januvia® and Janumet®, adding information that acute pancreatitis (inflammation of the pancreas) occurred in 88 patients using the medications. These 88 cases appeared after the medication was on the market (as opposed to occurring in clinical trials).

The FDA said it is working with Merck, the manufacturer of the drugs, to change the prescribing information and recommendations to reflect the new findings. These were:

• The occurrence of acute pancreatitis including the more severe forms of the disease — hemorrhagic or necrotizing pancreatitis
• Recommendations that healthcare professionals closely follow patients who either were just introduced to the drugs or whose doses were being increased
• Information noting that research has not been done on whether patients with a history of pancreatitis were at an increased risk of developing the condition while taking sitagliptin or sitagliptin/metformin
• In patients with a known history of pancreatitis, doctors need to prescribe these drugs cautiously
• The FDA plans to update the information thus far provided when it becomes available
• Doctors are asked to report any unexpected or adverse reactions in patients taking these medications
• If the doctor suspects the occurrence of pancreatitis, the drugs sitagliptin or sitagliptin/metformin should be stopped
• Patients should be told of the possibility of the occurrence of acute pancreatitis, its signs and symptoms, so they can report these to their doctors

Patients who have kidney disease or are on dialysis may need special changes in their doses and certain tests to assure they are safe when taking Januvia® and Janumet®.

You May Qualify to Seek Compensation

If you feel that you’ve been harmed by one of these diabetes medications, you may be able to seek compensation for your injuries and losses. Find out how, by speaking with one of our experienced drug attorneys in a free and confidential consultation. Contact a Januvia defect attorney today.