Januvia Warnings

Januvia Side Effects, Warnings And Precautions

It is very rare that patents taking Januvia will experience severe side effects. In case any patient experiences severe side effects, the patient must immediately stop using the drug and consult the doctor. Some of the severe side effects that can be experienced include: Pancreatitis that causes severe pain in upper stomach and back. Other symptoms of pancreatitis include vomiting, nausea and loss of appetite. Low blood sugar with symptoms including weakness, headache, fast heart rate, dizziness, hunger, etc. Severe skin reaction with symptoms like swelling of the face, lips, tongue and throat. Pain in skin followed by a red or purple skin rash that spreads and causes blistering and peeling. Patients using Januvia must be aware of certain warnings and precautions related with the drug in order to safely and effectively use the drug. One should be aware of potential allergic reactions the drug may cause and the potential risk for the patients suffering kidney problems. Januvia is not recommended to individuals, who are allergic to Sitagliptin or any other ingredients of the drug. One should avoid Januvia on experiencing symptoms of pancreatitis or kidney problem. Pregnant women should take Januvia only after the recommendation of their doctor. The effects of Januvia are not known on an unborn baby. Patients suffering from type 1 diabetes should not use Januvia. Januvia is also not recommended for the people with diabetic ketoacidosis. Patients suffering from any of the following diseases should cautiously use Januvia and must consult the doctor prior taking Januvia: Had inflammation or infection of the pancreas Continue reading >>

Fda Adds Heart Failure Warning To Januvia And Janumet

Despite neutral heart outcome study results, the FDA added a warning for those at risk of heart failure Januvia, a once-daily pill for type 2 diabetes (a DPP-4 inhibitor), has a new warning label for increased risk of heart failure. Though a recent outcome study showed clearly that Januvia is no riskier for the heart, the FDA seems to be taking a conservative approach based on other studies of similar drugs. The heart outcomes trial in question was called TECOS, which compared people taking Januvia, Janumet, or Janumet XR (sitagliptin) to people taking placebo. The study reported a neutral finding – the drugs in the Januvia family neither increased nor decreased instances of hospitalization for heart failure. In contrast, Onglyza, another DPP-4 inhibitor with the same heart failure warning as Januvia now has, was associated with a 27% increase in heart failure hospitalizations in the SAVOR-TIMI heart outcome trial. The FDA has also included heart failure warnings for Nesina and Tradjenta, the other two FDA-approved DPP-4 inhibitors. The warning added to the Januvia label appears to be a “just-in-case” decision by the FDA, based on the studies of DPP-4 inhibitors other than Januvia. It should be noted that the FDA warning label for Januvia and Janumet (which combines Januvia and metformin) cautions against prescribing these medications for people at risk for heart failure. What that means is for people without risk for heart failure, Januvia is considered a viable treatment option. (Major risk factors for heart failure include a history of heart attack, coronary artery disease, or high blood pressure.) Januvia and other DPP-4 inhibitors are typically used early in the course of type 2 diabetes, as they bring low risk of hypoglycemia and few side effects. Whether yo Continue reading >>

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: Indications, Side Effects, Warnings - Drugs.com

Generic Name: Sitagliptin (sit a GLIP tin) It is used to lower blood sugar in patients with high blood sugar (diabetes). What do I need to tell my doctor BEFORE I take Januvia? If you have an allergy to sitagliptin or any other part of Januvia (sitagliptin). If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives ; itching; shortness of breath; wheezing ; cough; swelling of face, lips, tongue, or throat; or any other signs. If you have any of these health problems: Acidic blood problem or type 1 diabetes . This is not a list of all drugs or health problems that interact with Januvia (sitagliptin). Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins ) and health problems. You must check to make sure that it is safe for you to take Januvia (sitagliptin) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. What are some things I need to know or do while I take Januvia? Tell all of your health care providers that you take Januvia (sitagliptin). This includes your doctors, nurses, pharmacists, and dentists. Do not drive if your blood sugar has been low. There is a greater chance of you having a crash. Check your blood sugar as you have been told by your doctor. Have blood work checked as you have been told by the doctor. Talk with the doctor. Talk with your doctor before you drink alcohol. Follow the diet and workout plan that your doctor told you about. It may be harder to control your blood sugar during times of stress like when you have a fever , an infection, an injury, or surgery . A change in level of physical activity or exercis Continue reading >>

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 >>

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 >>

Januvia Warnings And Precautions

Diabetes Home > Januvia Warnings and Precautions Some Januvia warnings and precautions to be aware of are related to potential allergic reactions the drug may cause, while others concern the danger of taking the medication when you have kidney problems. Before taking Januvia, notify your healthcare provider about any kidney problems or allergies you may have. It's possible that Januvia could interact with other drugs, so tell your healthcare provider about any other medicines you are taking. Januvia: What Should I Tell My Healthcare Provider? You should talk with your healthcare provider prior to taking Januvia ( sitagliptin ) if you have: Kidney problems, including kidney failure (renal failure) Had pancreatitis (inflammation or infection of the pancreas ) in the past Any allergies , including allergies to foods, dyes, or preservatives. Also, let your healthcare provider know if you are: Pregnant or thinking of becoming pregnant Tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some Januvia warnings and precautions to be aware of include the following: Very preliminary data suggests incretin mimetics, such as Januvia, may increase the risk of precancerous cellular changes (called pancreatic duct metaplasia) in people with type 2 diabetes . Researchers are continuing to study the possibility that incretin mimetics might increase the risk of pancreatic cancer , although at this time there is not enough information to know for sure if there is any increased risk. There have been some reports of pancreatitis in people taking Januvia. This is probably most likely to occur shortly after the drug is first started or when the dosage is increased. Be sure to let your healt Continue reading >>

Fda Warns Of Heart-failure Risk With Two Diabetes Drugs

FDA Warns of Heart-Failure Risk With Two Diabetes Drugs (updated April 6) The US Food and Drug Administration (FDA) has issued a new alert about the potential for increased risk for heart failure in patients taking the type 2 diabetes drugs saxagliptin (Onglyza, AstraZeneca) and alogliptin (Nesina, Takeda). The FDA announced that new warnings will be added to the labels of the two dipeptidyl peptidase4 (DPP-4) inhibitor drugs, cautioning that they may increase the risk for heart failure, particularly in patients who already have cardiovascular or kidney disease. "Healthcare professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control," an FDA statement notes. "If a patient's blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required." Combination products containing the two agents are also affected, including saxagliptin and metformin extended release (Kombiglyze XR, AstraZeneca ), alogliptin and metformin (Kazano, Takeda), and alogliptin and pioglitazone (Oseni, Takeda). The move follows an FDA internal safety review of two large cardiovascular-outcomes trials of patients with cardiovascular disease and a recommendation for the label revision by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee during an April 2015 hearing. At that meeting, the panel expressed greater concern about heart failure for saxagliptin than for alogliptin, but because the mechanism is not clear and the two belong to the same class, the majority opted to recommend the warning on both labels. However, in the interim, a third large cardiovascular-outcomes trial with another DPP-4 inhibitor, sitagliptin (Januvia, Merck), the T Continue reading >>

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 >>

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 >>

Januvia Side Effects Center

Januvia (sitagliptin) is an oral diabetes medicine for people with type 2 diabetes (non-insulin-dependent) diabetes. Januvia is sometimes used in combination with other diabetes medications, but is not for treating type 1 diabetes. Many people using Januvia do not have serious side effects. Side effects that may occur with Januvia include: headache, joint or muscle pain, nausea, stomach pain, diarrhea, or constipation. Although Januvia by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if Januvia is prescribed with other anti-diabetic medications. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. Tell your doctor if you have serious side effects of Januvia including pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, fast heart rate), urinating less than usual or not at all, swelling, weight gain, shortness of breath, or severe skin reaction (fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads [especially in the face or upper body] and causes blistering and peeling). The recommended dose of Januvia is 100 mg once daily. Januvia may interact with digoxin, probenecid, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), or beta-blockers. Tell your doctor all prescription and over-the-counter medications you use. During pregnancy Januvia should be used only when prescribed. Pregnancy may cause or worsen diabetes. Your doctor may change your diabetes treatment during pregnancy. It is unknown if this drug passes into breast milk. Cons Continue reading >>

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 >>

Fda Drug Safety Communication: Fda Warns That Dpp-4 Inhibitors For Type 2 Diabetes May Cause Severe Joint Pain

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. 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. 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 (see Table 1 below). In a search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature,1-4 we identified cases of severe joint pain associated with the use of DPP-4 inhibitors. Patients started having symptoms from 1 day to years after they started taking a DPP-4 inhibitor. 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. We urge health care professionals and patients to report side effects involving DPP-4 inhibitors to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page. Table 1. List Continue reading >>

Januvia Gets New Warnings Over Fatal Skin Reactions

Home / Resources / Articles / Januvia Gets New Warnings Over Fatal Skin Reactions Januvia Gets New Warnings Over Fatal Skin Reactions Merck & Co. added warnings to its diabetes pill Januvia after some patients developed allergic conditions, including a rare, severe skin disorder. Among the illnesses reported by Januvia users was a sometimes fatal skin ailment called Stevens-Johnson syndrome, Merck said today in a statement. Merck said there wasnt enough data to conclude whether the drug was the cause. Merck said some patients also suffered anaphylaxis, a severe whole-body allergic reaction that can cause a person to go into shock, and angioedema, a swelling of the skin that leads to welts. The findings are included in the drugs prescribing information. Januvia is one of Mercks most important new products with $144 million in sales in the second quarter. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure, according to the prescribing information. There were no reports of Stevens-Johnson syndrome in Mercks own studies involving 6,000 patients who have taken Januvia, said John Amatruda, vice president of clinical research at Merck, in an interview today. The number of reactions reported to Merck, based in Whitehouse Station, New Jersey, and U.S. regulators was greater than what would be expected in the general population, Amatruda said. Adverse events are reported voluntarily, sometimes with little information, making it difficult to confirm them or determine whether the cause, he said. Merck today also said it received expanded approval to market Januvia in combination with the diabetes drug metformin as a first-line tre Continue reading >>

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 >>