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Januvia Fda Warning

Sitagliptin

Sitagliptin

Sitagliptin (INN; /sɪtəˈɡlɪptɪn/ ( listen), previously identified as MK-0431 and marketed as the phosphate salt under the trade name Januvia) is an oral antihyperglycemic (antidiabetic drug) of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. It was developed, and is marketed, by Merck & Co. This enzyme-inhibiting drug is used either alone or in combination with other oral antihyperglycemic agents (such as metformin or a thiazolidinedione) for treatment of diabetes mellitus type 2.[2] Adverse effects[edit] Side effects are as common with sitagliptin (whether used alone or with metformin or pioglitazone) as they were with placebo, except for rare nausea and common cold-like symptoms, including photosensitivity.[3] No significant difference exists in the occurrence of hypoglycemia between placebo and sitagliptin.[3][4][5] In those taking sulphonylureas, the risk of low blood sugar is increased.[6] The existence of rare case reports of renal failure and hypersensitivity reactions is noted in the United States prescribing information, but a causative role for sitagliptin has not been established.[7] Several postmarketing reports of pancreatitis (some fatal) have been made in people treated with sitagliptin and other DPP-4 inhibitors,[8] and the U.S. package insert carries a warning to this effect,[9] although the causal link between sitagliptin and pancreatitis has not yet been fully substantiated.[2] One study with lab rats published in 2009 concluded that some of the possible risks of pancreatitis or pancreatic cancer may be reduced when it is used with metformin. However, while DPP-4 inhibitors showed an increase in such risk factors, as of 2009, no increase in pancreatic cancer has been reported in individuals taking DPP-4 inhibitors.[10] The updated (August 20 Continue reading >>

Januvia Warning - Fda Warnings & Associated Risks To Diabetes Patients

Januvia Warning - Fda Warnings & Associated Risks To Diabetes Patients

Januvia, which is the brand name version of sitagliptin, is a once-a-day medication sold by Merck for the treatment of type-2 diabetes. Introduced in 2006, it has become one of the best selling diabetes drugs in the world, with use in over 80 countries. Unfortunately, the FDA, American Medical Association and researchers at UCLA have issued a Januvia warning in recent years linking the drug to increased risks of pancreatic cancer or thyroid cancer. Januvia can lower blood-sugar levels in people with diabetes by inhibiting the enzyme DPP-4, which is a natural barrier to insulin creation. This increases insulin production and the absorption of sugar from the blood. However, DPP-4 may also prevent the spread of cancerous cells, meaning Januvia may reduce the bodys natural protection against cancer. The FDA first issued a Januvia warning in 2009 after receiving more AERS adverse event reports than expected showing patients were developing pancreatitis while taking the drug. At that time, they forced Merck to add label warnings for pancreatitis. However, Merck has not issued a Januvia warning advising consumers of the risk of pancreatic cancer or thyroid cancer. Due to their failure to properly warn patients of these risks, they face liability for the damages. If you or a loved one have been diagnosed with pancreatic cancer or thyroid cancer after taking Januvia, it is important to speak with a lawyer about your legal rights as soon as possible. You may be entitled to substantial compensation. Contact us today. Records show that even after warnings from experts that Januvia may be associated with pancreatic or thyroid cancer, Merck has continued making billions each year selling the drug without proper warning, and has delayed important testing ordered by the FDA. In 2011, Continue reading >>

Heart Failure Warning Added To The Dpp-4 Inhibitor Class Of Drugs

Heart Failure Warning Added To The Dpp-4 Inhibitor Class Of Drugs

Increased cardio risk of Saxagliptin found during trial prompts FDA decision. Sitagliptin (Januvia) is a DPP-4 antidiabetic oral agent for treating type 2 diabetes. A new warning label regarding the risk of developing heart failure in patients with cardiovascular disease was issued to this drug by the FDA in September 2017. Other drugs within the same class, Nesina and Tradjenta, were also issued this warning, suggesting the associated risk to be a “class-effect” of the DPP-4 inhibitors. To date, no direct studies have linked this drug with increasing risk of cardiovascular events, including heart failure. Saxagliptin (Onglyza), another DPP-4 inhibitor, was found to increase the risk of hospitalization for heart failure and the risk of hypoglycemic events. This study found that more patients in the Saxagliptin group than in the placebo group were hospitalized for heart failure.(1) This study happened to be the evidence and reason behind the FDA’s decision to correct Sitagliptin’s package insert. It appears that the FDA issued such warning in a conservative way without a solid controlled trial supporting the cardiovascular risk. From 2008 until 2015, a major randomized, double-blind, placebo-controlled, event-driven trial was conducted by Duke Clinical Research Institute (DCRI) and the University of Oxford Diabetes Trials Unit (DTU). It evaluated a total of 14,735 patients with established cardiovascular disease. They compared the sitagliptin group vs placebo. The primary endpoint was the risk of developing major cardiovascular events such as nonfatal MI, nonfatal stroke, cardiovascular death, or unstable angina. Mean follow-up was 3 years and included patients from 38 different countries. Baseline characteristics were well balanced for both groups and all cardio Continue reading >>

New Fda Warning About Januvia Joint Pain Side Effect

New Fda Warning About Januvia Joint Pain Side Effect

On August 28, 2015, the FDA issued the following caution: “The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. We have added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors.” The agency specifies that patients should not stop their medication but should contact the prescriber immediately if “they experience severe and persistent joint pain.” The FDA wants health care professionals to understand that drugs in this class can cause serious joint pain and if that occurs they should recognize that it is not necessarily because a patient is “getting older” or developing sudden arthritis. The alert points out that symptoms can start within a day of beginning one of these drugs or come on gradually, after years of use without symptoms. The FDA states: “After the patients discontinued the DPP-4 inhibitor medicine, their symptoms were relieved, usually in less than a month. Some patients developed severe joint pain again when they restarted the same medicine or another DPP-4 inhibitor.” Januvia Joint Pain Side Effect: Over the last several years the FDA has approved a number of new medications to treat type 2 diabetes. They include Januvia (sitagliptin) and Janumet (sitagliptin + metformin), Nesina (alogliptin), Onglyza (saxagliptin), and Tradjenta (linagliptin). Januvia has been widely advertised and is one of the best-selling diabetes drugs, earning billions annually for its manufacturer. Januvia Television Commercials: Perhaps you have seen the Januvia TV commercials and didn’t even realize it. They promote the idea tha Continue reading >>

Fda Shoots Down Merck's Bid To Add Lack Of Heart Risks To Januvia's Label

Fda Shoots Down Merck's Bid To Add Lack Of Heart Risks To Januvia's Label

FDA shoots down Merck's bid to add lack of heart risks to Januvia's label Results of Merck's TECOS outcomes study showed Januvia, unlike some of its DPP-4 brethren, didn't hurt heart health. With diabetes rivals coming up with heart-helping outcomes data, Merck at least wants data on its label showing its Januvia doesnt hurt heart health.U.S. regulators, though, say not so fast. Friday, they hit the New Jersey drugmaker with a complete response letter rejecting Mercks sNDAs for Januvia and related combos Janumet and Janumet XR. The company had sought to add results from its TECOS outcomes triala heart study that turned up no red flagsto all three drugs. Merck is reviewing the letter and will discuss next steps with the FDA, it said in a statement. Like this story? Subscribe to FiercePharma! Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go. Continue reading >>

Sitagliptin (januvia) Linked To Increase In Heart Failure Hospitalizations

Sitagliptin (januvia) Linked To Increase In Heart Failure Hospitalizations

Sitagliptin (Januvia) Linked to Increase in Heart Failure Hospitalizations Study analyzes patients with diabetes and pre-existing HF For several years, the cardiovascular effects of drugs used for glucose control in patients with diabetes have been a subject of controversy. Now, a new observational study has evaluated the effects of the dipeptidyl peptidase (DPP)-4 inhibitor sitagliptin (Januvia, Merck) in patients with type-2 diabetes and heart failure (HF). The studys findings were published in the July 2014 issue of the Journal of the American College of Cardiology. Investigators in Canada analyzed data from a national commercially insured U.S. claims database. Patients with incident HF were identified from individuals with type-2 diabetes initially treated with metformin or sulfonylurea and followed over time. Subjects subsequently treated with sitagliptin were compared with those not treated with the drug in the 90 days before the composite primary outcome of all-cause hospital admission or death. HF-specific hospital admission or death also was assessed. A total of 7,620 patients with diabetes and incident HF met the studys inclusion criteria. The patients mean age was 54 years, and 58% were male. Overall, 887 patients (12%) were exposed to sitagliptin therapy (521 patient-years of exposure) after incident HF. The studys composite primary endpoint occurred in 4,137 patients (54%). After adjustment, sitagliptin users did not demonstrate an increased risk for the primary endpoint compared with non-users (7.1% vs. 9.2%, respectively; adjusted odds ratio [aOR]: 0.84) or for each component of the primary endpoint (i.e., hospital admission: 7.5% vs. 9.2%; aOR: 0.93; and death: 6.9% vs. 9.3%; aOR: 1.16). However, subjects using sitagliptin showed an increased risk for H Continue reading >>

Januvia

Januvia

are allergic to dapagliflozin or any of the ingredients in FARXIGA. Symptoms of a serious allergic reaction may include skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking FARXIGA and contact your healthcare provider or go to the nearest hospital emergency room right away have severe kidney problems or are on dialysis. Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with FARXIGA Dehydration (the loss of body water and salt), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you have low blood pressure; take medicines to lower your blood pressure, including water pills (diuretics); are 65 years of age or older; are on a low salt diet, or have kidney problems Ketoacidosis occurred in people with type 1 and type 2 diabetes during treatment with FARXIGA. Ketoacidosis is a serious condition which may require hospitalization and may lead to death. Symptoms may include nausea, tiredness, vomiting, trouble breathing, and abdominal pain. If you get any of these symptoms, stop taking FARXIGA and call your healthcare provider right away. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL Kidney problems. Sudden kidney injury occurred in people taking FARXIGA. Talk to your doctor right away if you reduce the amount you eat or drink, or if you lose liquids; for example, from vomiting, diarrhea, or excessive heat exposure Serious urinary tract infections (UTI), some that lead to hospitalization, occu Continue reading >>

Fda Turns Down Sitagliptin Heart Data For Drug Label

Fda Turns Down Sitagliptin Heart Data For Drug Label

FDA Turns Down Sitagliptin Heart Data for Drug Label TECOS results apparently not good enough to warrant new claim by Kristen Monaco, Contributing Writer, MedPage Today This article is a collaboration between MedPage Today and: WASHINGTON -- The FDA told Merck & Co. that it wouldn't approve the company's application to include cardiovascular safety data on the labels of its sitagliptin-containing type 2 diabetes drugs -- Januvia (sitagliptin), Janumet (sitagliptin and metformin HCl), and Janumet XR (sitagliptin and metformin HCl extended-release). The results of the TECOS Trial (Trial Evaluating Cardiovascular Outcomes with Sitagliptin), which were presented at the 2015 American Diabetes Association's annual meeting, reported no increase for adverse heart-related outcomes or hospitalization for heart failure in the nearly 15,000 participants with type 2 diabetes and a history of cardiovascular disease, when compared to placebo. However, Sanjay Kaul, MD, of Cedars-Sinai Medical Center in Los Angeles, said it appears the TECOS results did not meet the FDA's criteria for cardiovascular safety claims. The FDA does not publicly disclose its reasons for rejecting applications. Merck had little to say about the decision: in a press release issued Friday, it said only that the company was "reviewing the letter and will discuss next steps with the FDA." The DPP-4 inhibitor class of drugs, which Januvia belongs to, has been previously linked to increased heart failure rates. However, an FDA advisory committee previously voted that DPP-4 inhibitors have an acceptable amount of CV risk, therefore not warranting any additional label restrictions. This setback for Merck comes after Boehringer Ingelheim's empagliflozin (Jardiance) was granted FDA approval late last year for a claim o Continue reading >>

Januvia (sitagliptin) Fda Medwatch Alerts

Januvia (sitagliptin) Fda Medwatch Alerts

The FDA Alert(s) below may be specifically about Januvia or relate to a group or class of drugs which include Januvia (sitagliptin). MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here . DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain Audience: Patient, Endocrinology, Family Practice, Internal Medicine ISSUE: The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin , saxagliptin , linagliptin , and alogliptin may cause joint pain that can be severe and disabling. FDA has added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors. See the Drug Safety Communication for a complete list of all FDA-approved DPP-4 inhibitors. BACKGROUND: DPP-4 inhibitors are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. These medicines are available as single-ingredient products and in combination with other diabetes medicines such as metformin. RECOMMENDATION: Patients should not stop taking their DPP-4 inhibitor medicine, but should contact their health care professional right away if they experience severe and persistent joint pain. Health care professionals should consider DPP-4 inhibitors as a possible cause of severe joint pain and discontinue the drug if appropriate. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of Continue reading >>

New Fda Warning That Januvia, Onglyza, Tradjenta, And Nesina Are Associated With

New Fda Warning That Januvia, Onglyza, Tradjenta, And Nesina Are Associated With "joint Pain That Can Be Severe And Disabling"

Label Changes About Side Effects For These Type 2 Diabetes Medicines In The Drug Class Called Dipeptidyl Peptidase-4 (DPP-4) Inhibitors In August 2015 the FDA announced that it has found indications of a new side effect for a class of diabetes drugs -- dipeptidyl peptidase-4 (DPP-4) inhibitors -- that includes Januvia, Onglyza, Tradjenta, and Nesina. The FDA found drug adverse event reports of arthralgia, or severe pain in one or more joints, associated with the use of DPP-4 inhibitor diabetes drugs, with Januvia being the one implicated most often, followed by Onglyza. According to the FDA, patients started having symptoms of the new side effect from one day to years after they started taking Januvia, Onglyza, Tradjenta, Nesina or one of the "combination" DPP-4 inhibitors, e.g., Janumet (sitagliptin and metformin). In more detail, the FDA reported that after the DPP-4 inhibitor medicine was discontinued, the patients' symptoms were usually relieved within less than a month of stopping the subject drug. Furthermore, some patients developed severe joint pain again when they restarted the same medicine or another DPP-4 inhibitor. This last fact provides some substantiation for linking this severe joint pain side effect with Januvia, Onglyza, Tradjenta, Nesina, and the other drugs in this DPP-4 inhibitors class. ____________________________________________________ Januvia / Onglyza / Tradjenta / Nesina Free Case Evaluation Strictly Confidential, No Obligation. _____________________________________________________ We get the following more detailed information from the "FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain" document that was issued on August 28, 2015: In a search of the FDA Adverse Event Reporting Sys Continue reading >>

Januvia And Janumet

Januvia And Janumet

Januvia (sitagliptin) is an oral Type 2 diabetes medication manufactured by Merck & Co. The U.S. Food and Drug Administration (FDA) approved the drug in 2006, and it is one of the most popular Type 2 diabetes drugs on the market. In 2007, the FDA approved a variation of Januvia called Janumet, which is a combination of sitagliptin and metformin. Janumet also comes in an extended-release formula called Janumet XR. Januvia and Janumet are known as dipeptidyl peptidase 4 (DPP-4) inhibitors that work by helping the body produce more insulin. Both Januvia and Janumet belong to a class of drugs called dipeptidyl peptidase 4 (DPP-4) inhibitors that work by helping the body produce more insulin. Januvia was the first DPP-4 approved by the FDA and is the top-selling brand in its class. Two million prescriptions were written for Januvia in 2011. Januvia brought in about $6 billion in 2014. Merck stands to benefit from the patent on the drug until 2022. In clinical trials, Januvia proved effective in controlling blood-sugar levels. However, some studies reported rare and serious side effects, including acute pancreatitis, severe joint pain, pancreatic cancer and thyroid cancer. How Do Januvia and Janumet Work? Januvia is designed to work with other Type 2 diabetes medications, like Byetta, to increase their effectiveness. It helps lower blood sugar in two ways. It helps the body increase insulin to stabilize blood sugar and decrease sugars that are made in the liver. It is a part of the class of diabetes medications called DPP-4 inhibitors. DPP-4 is a protein made by the body that plays a role in glucose metabolism. The process works like this: After a person eats and blood sugar rises, intestinal cells release hormones called incretin hormones. Incretin stimulates pancreatic cell Continue reading >>

Januvia

Januvia

JANUVIA® (sitagliptin) Tablets DESCRIPTION JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5O•H3PO4•H2O and the molecular weight is 523.32. The structural formula is: Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide. For Consumers What are the possible side effects of sitagliptin (Januvia)? Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking sitagliptin and call your doctor at once if you have a serious side effect such as: pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, fast heart rate; or urinating less than usual Continue reading >>

Merck Receives Complete Response Letter From The U.s. Fda For Tecos Study With Sitagliptin

Merck Receives Complete Response Letter From The U.s. Fda For Tecos Study With Sitagliptin

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck’s Supplemental New Drug Applications for JANUVIA® (sitagliptin), JANUMET® (sitagliptin and metformin HCl) and JANUMET XR® (sitagliptin and metformin HCl extended-release). With these applications, Merck is seeking to include data from TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) in the prescribing information of sitagliptin-containing medicines. Merck is reviewing the letter and will discuss next steps with the FDA. Important Information about JANUVIA® (sitagliptin) 25 mg, 50 mg and 100 mg tablets JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUVIA. Selected Important Risk Information about JANUVIA® JANUVIA is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. There have been postmarketing reports of acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in patients taking JANUVIA. After initiating JANUVIA, observe patients carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue JANUVIA and initiate appropriate management. It is unknown whether patients with a history of pancreatitis ar Continue reading >>

Januvia Fda Warning Information

Januvia Fda Warning Information

There have been several warnings from the FDA regarding side effects of Januvia , including dozens of cases of pancreatitis (pancreas inflammation), hemorrhagic and necrotizing pancreatitis, and pre-cancerous growths that may indicate a risk of pancreatic cancer. The Schmidt Firm, PLLC is currently accepting Januvia induced injury cases in all 50 states. If you or somebody you know was diagnosed with pancreatic cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753. In August 2015, the FDA issued a Safety Communication to warn about the risk of severe, disabling joint pain from Januvia. Between October 2006 and December 2013, the agency received 28 reports of Januvia patients who were diagnosed with severe joint pain. Many of the patients experienced pain that was so severe they were disabled and/or had to be hospitalized. In most cases, symptoms appeared within 1 month of starting Januvia and resolved after the medication was discontinued. In March 2013, the FDA issued a Safety Communication and began investigating the risk of pancreatic cancer from Januvia. The agency was concerned about a study published in Diabetes linking Januvia with pre-cancerous pancreatic growths. Researchers autopsied eight pancreases, including 7 from patients who used Januvia for at least one year. On average, the pancreases were 40% larger than normal due to exocrine cell proliferation (95% of pancreatic cancers start in exocrine cells). Many of the cells were eccentrically shaped and three pancreases had pre-cancerous growths (microadenomas and a neuroendocrine tumor) that could become malignant. In March 2013, the FDA also warned about a Continue reading >>

Important Safety Information

Important Safety Information

WHAT IS JANUVIA®? JANUVIA (jah-NEW-vee-ah) is a once-daily prescription pill that, along with diet and exercise, helps lower blood sugar levels in adults with type 2 diabetes. JANUVIA should not be used in patients with type 1 diabetes or with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking JANUVIA. Serious side effects can happen in people who take JANUVIA, including pancreatitis, which may be severe and lead to death. Before you start taking JANUVIA, tell your doctor if you've ever had pancreatitis. Stop taking JANUVIA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis. Before you start taking JANUVIA, tell your doctor if you have ever had heart failure (your heart does not pump blood well enough) or have problems with your kidneys. Contact your doctor right away if you have increasing shortness of breath or trouble breathing (especially when you lie down); swelling or fluid retention (especially in the feet, ankles, or legs); an unusually fast increase in weight; or unusual tiredness. These may be symptoms of heart failure. Do not take JANUVIA if you are allergic to any of its ingredients, including sitagliptin. Symptoms of serious allergic reactions to JANUVIA, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, can occur. If you have any symptoms of a serious allergic reaction, stop taking JANUVIA and call your doctor right away. Kid Continue reading >>

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