diabetestalk.net

Januvia Patient Reviews

Sitagliptin | Nature Reviews Drug Discovery

Sitagliptin | Nature Reviews Drug Discovery

Sitagliptin phosphate (Januvia; Merck) was approved by the US FDA for the treatment of type 2 diabetes mellitus in October 2006. It is the first in a new class of drugs that inhibit the proteolytic activity of dipeptidyl peptidase-4, thereby potentiating the action of endogenous glucoregulatory peptides, known as incretins. Subscribe to Nature Reviews Drug Discovery for full access: Therapeutic strategies based on glucagon-like peptide-1 Enhanced insulin secretion and improved glucose tolerance in mice lacking CD26 . Proc. Natl Acad. Sci. USA 97, 68746879 (2000). Inhibition of dipeptidyl peptidase IV improves metabolic control over a 4-week study period in type 2 diabetes (2R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine: a potent, orally active dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial Daniel Drucker is at the Banting and Best Diabetes Centre, Samuel Lunenfeld Research Institute, Mount Sinai Hos Continue reading >>

Januvia Pancreatic Cancer, Januvia Thyroid Cancer

Januvia Pancreatic Cancer, Januvia Thyroid Cancer

Januvia is a drug prescribed to help treat adults with type-2 diabetes. In September 25, 2009 the FDA issued a revision to the warning label of the drug Januvia or Janumet--a combination drug comprised of Januvia and Metformin--regarding Januvia side effects, including Januvia pancreatic cancer and Januvia thyroid cancer. If you have taken the Januvia diabetes drug and are concerned about Januvia and cancer and/or Januvia and pancreatitis, you should speak with an attorney about a possible Januvia lawsuit. Januvia is a type 2 diabetes that is also available in a combination pill (known as Janumet) that contains the drug metformin. (Janumet 50/500 is 500mg of Metformin plus 50mg of Januvia.) Januvia (sitagliptin) and Janumet (sitagliptin/metformin) are the first in a new class of oral diabetes medications, called dipeptidyl peptidase-4 (DPP-4) inhibitors that improve blood sugar control in patients with type 2 diabetes. Januvia - which works by affecting different cells in the pancreas - first came on the market in late 2006. However, after that release, the FDA received dozens of reports of pancreatitis from patients who were using Januvia. For many, their symptoms were later resolved once they stopped taking the drug. Sorry, no compatible source and playback technology were found for this video. Try using another browser like Chrome or download the latest Adobe Flash Player. Januvia was approved by the FDA in October 2006. Between October 16, 2006 and February 9, 2009, the agency received 88 post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis. Sixty-six of those patients required hospitalization, and four of the patients were transferred to the intensive care unit. The FDA review of these 88 patients found that 19 Continue reading >>

Sitagliptin (januvia) For The Treatment Of Patients With Type 2 Diabetes

Sitagliptin (januvia) For The Treatment Of Patients With Type 2 Diabetes

SAFETY Two large trials have assessed the effectiveness and safety of sitagliptin alone or in combination with metformin in adult patients with type 2 diabetes. Hypoglycemia rates in patients receiving sitagliptin were similar to those in patients receiving placebo or metformin alone, with no incidents of severe hypoglycemia1–3; however, it is unknown whether sitagliptin will increase hypoglycemic events when combined with sulfonyl-ureas or insulin. Hepatic insufficiency appears to have minimal effect on sitagliptin concentrations and requires no dosage adjustment. Patients with moderate renal insufficiency (creatinine clearance of 30 to 50 mL per minute [0.50 to 0.83 mL per second]) should reduce daily dosages to 50 mg, and patients with severe kidney dysfunction (creatinine clearance of less than 30 mL per minute [0.50 mL per second]) should take 25 mg daily.4,5 Sitagliptin is U.S. Food and Drug Administration pregnancy category B.5 TOLERABILITY Overall, reports of side effects with sitagliptin are similar to those reported with placebo. Respiratory symptoms (e.g., nasopharyngitis, respiratory tract infection, cough) occur more often with sitagliptin than with placebo or other oral hypoglycemics; however, those rates are still low. Gastrointestinal side effects are uncommon, and weight gain does not occur.1–3,5 None of these side effects resulted in discontinuation of treatment.1,2 EFFECTIVENESS Only three clinical trials evaluating the effectiveness of sitagliptin have been published, with a total enrollment of fewer than 2,000 patients.1–3 The trials showed that after six months of monotherapy with sitagliptin, A1C levels decreased by an average of 0.8 percent in patients with a baseline A1C of 8.1 percent.1,4 In patients with moderately uncontrolled diabetes Continue reading >>

Januvia

Januvia

I'm maxed out on metformin (850 mg 3x/day) and glyburide (5mg 4x/day). Januvia, even without the other 2 meds, had my readings in the desired ranges in a day. It's only been 5 days, but so far VERY GOOD! Thanks! Started Januvia 100 mg once a day with in days I had joint pain so bad I did not want to get out of bed and the join pain has not went away its not as bad but still there. Chronic heart pain my heart beat so hard and fast I worried I was having a heart attack. My chest was/is sore I have congestion, I still have a fast heart beat off and on "This worries me". Shortness of breath. I was dizzy, chest colds, Very bad headache, Both hands were numb this was worse at night I would wake with my hands hurting I still have some numbness it is off and on and and mostly in my fingers now. I was so hoping Januvia would work for me. I do not think this drug was not tested well enough before the public was allowed to use it. I hope my side effects are not long term and no damage was caused and with time will go away. I was on another medication for type 2 diabetes and it didnot work for me. My doctor didn't want to take me off of it because he said it work for most people. Well, I change Doctors and the new Doctor stated me on Januvia 50 mg in the AM and 50 in the PM and it started to work at the end of the week, no side effects, my number was very close to normal and I feel GREAT . I even lost weight while on this medication. My husband is on 50 mg a day and doing great with no side effects. Family member had a rash with this medicine, and a friend said there was a new warning posted about a deadly disease called Stevens-Johnson syndrome associated with Januvia. I didn't find it in WebMd though. Is it true? Januvia (with metformin) has worked very well for me so far (3 mont Continue reading >>

Januvia Reviews | Everyday Health

Januvia Reviews | Everyday Health

Only rate drugs or treatments you've tried. In your description, mention the brand, dose, and period of time that you used the drug or treatment. Please share your positive and negative experiences with the drug, and compare it with other treatments you have used. Do not include any personal information or links in your review. Would you recommend this drug? (required) How effective was this drug in treating your condition? (required) How easy was it to take this drug? (required) Did you experience side effects while using this drug? (required) Share your experience with Januvia (required) I have read and agreed to the EverydayHealth.com Terms of Service and Privacy Policy . I was on Glipizide for a period of two years. Metformin prior to that. I have been on Januvia for 45 days. I feel better and I have lost about 16 pounds. It has really lowered my blood sugar levels. There were no side effects noted. Drugs A-Z provides drug information from Everyday Health and our partners, as well as ratings from our members, all in one place. Cerner Multum provides the data within some of the Basics, Side Effects, Interactions, and Dosage tabs. The information within the Reviews and FAQ tabs is proprietary to Everyday Health. You can browse Drugs A-Z for a specific prescription or over-the-counter drug or look up drugs based on your specific condition. This information is for educational purposes only, and not meant to provide medical advice, treatment, or diagnosis. Remember to always consult your physician or health care provider before starting, stopping, or altering a treatment or health care regimen. Every effort has been made to ensure that the information provided by on this page is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug informatio Continue reading >>

New Concerns Over Byetta And Januvia Underscore The Value Of Older And Cheaper Diabetes Drugs

New Concerns Over Byetta And Januvia Underscore The Value Of Older And Cheaper Diabetes Drugs

New concerns over Byetta and Januvia underscore the value of older and cheaper diabetes drugs Consumer Reports News: March 05, 2013 09:13 AM If you take Byetta or Januvia to control your blood sugar levels, you might have a small, but increased risk for a condition marked by stomach pain and nausea. Not only are the drugs more expensive and no more effective than our Best Buy Drug picks for diabetes , they're associated with an increased risk for pancreatitis, or an inflamed pancreas, according to a new study in JAMA Internal Medicine. We recommend asking your doctor if you shouldn't be taking another drug in the first place. Researchers at Johns Hopkins in Baltimore analyzed the medical records of 1,269 people with type 2 diabetes who filled at least one prescription for any diabetes drug over a three-year period. The researchers found 87 of the patients who developed pancreatitis were taking Byetta or Januvia, while 58 of the people who developed pancreatitis were taking some other diabetes drug. Tens of millions of people take these drugs, though our experts say other drugs--metformin (Glucophage and generic) and a sulfonylurea (glipizide or glimepride)--are better first choices for most people. "In my opinion, Byetta and Januvia are third-line medications for type 2 diabetes, behind metformin and sulfonylureas" says Marvin M. Lipman, M.D., an endocrinologist and Consumer Reports' chief medical adviser. "And patients who take them should be warned about the early signs of pancreatitis." Also talk with your doctor about lifestyle changes, such as weight loss and dietary changes, that can help you control the disease. Those measures can be as effective medication, especially in the early stages of diabetes. 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 >>

Januvia Study Shows What's Wrong With U.s. Health Care

Januvia Study Shows What's Wrong With U.s. Health Care

Does the story adequately discuss the costs of the intervention? There was no discussion of costs in this story. Cost information is available. It costs about $350 for 30 tablets of 100 mg each. Does the story adequately quantify the benefits of the treatment/test/product/procedure? The focus of the story is on the drugs risk profile, but we think the story should have provided at least some information about whether this drug has been shown to be more efficacious than other therapies. The story missed what was in our view one of the most important points of the study: the practically nonexistent benefit in reducing blood sugar compared with existing therapy. And, while the drug did not increase rates of cardiovascular disease, it also did not reduce them. Also, the study followup was relatively short; median follow up of 3 years. That could have been mentioned somewhere. Does the story adequately explain/quantify the harms of the intervention? The story is focused on the potential harms of the drug and it does a fairly good job explaining the differences between the risks for different bad outcomes from the drug and from a placebo. We give very high marks to the story for providing both comparisons using percentages but also using absolute numbers throughout. So, for example, the story said,There were 228 such hospitalizations for Januvia and 229 in the placebo group, according to data also published in the New England Journal of Medicine. It also does a nice job of explaining, at least in one instance, that some of the comparisons between the drug and placebo are not statistically significant. For example, the story said that, There was also no significant difference between Januvia and placebo in infections, cancer, kidney failure or severe hypoglycemia, which is da Continue reading >>

Review Of Sitagliptin Phosphate: A Novel Treatment For Type 2 Diabetes

Review Of Sitagliptin Phosphate: A Novel Treatment For Type 2 Diabetes

Review of sitagliptin phosphate: a novel treatment for type 2 diabetes Dept. Medicine IV, Eberhard Karls University, Tuebingen, Germany Correspondence: Baptist Gallwitz Dept. Medicine IV, Eberhard Karls University, Otfried Mueller Str. 10, 72076 Tuebingen, Germany Tel + 49 7071 298 2093 Fax + 49 7071 29 5004 Email [email protected] Copyright 2007 Dove Medical Press Limited. All rights reserved This article has been cited by other articles in PMC. Sitagliptin (Januvia, Merck Pharmaceuticals) is a dipeptidyl-peptidase inhibitor (DPP-4 inhibitor) that has recently been approved for the therapy of type 2 diabetes. Like other DPP-4 inhibitors its action is mediated by increasing levels of the incretin hormones glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP). Sitagliptin is effective in lowering HbA1c, and fasting as well as postprandial glucose in monotherapy and in combination with other oral antidiabetic agents. It stimulates insulin secretion when hyperglycemia is present and inhibits glucagon secretion. In clinical studies it is weight neutral. This article gives an overview of the mechanism of action, the pharmacology, and the clinical efficacy and safety of sitagliptin in type 2 diabetes therapy. Keywords: incretins, type 2 diabetes, diabetes therapy, DPP-4 inhibitors, sitagliptin Utilizing the therapeutic potential of GLP-1 in type 2 diabetes Since glucagon-like peptide-1 (GLP-1) itself is not feasible for type 2 diabetes therapy due to its very short biological half-life, two major strategies have been developed to utilize the beneficial effects of GLP-1 ( Drucker 2006 ). On the one hand, long-acting, dipeptidyl-peptidase ihibitor (DPP-4 inhibitor)-resistant peptides with a high similarity to the native GLP-1 can be used Continue reading >>

Januvia Patient-centered Health, Reviews And Testimonials

Januvia Patient-centered Health, Reviews And Testimonials

Acid Reflux & Heartburn Acne Addison's des Alcoholism Allergic Reaction Allergies Alopecia Areata Altitude Sickness / Mountain Sickness Alzheimer's Amblyopia Anemia Anesthetic Reversal Anesthetics Angina (Chest Pain) Angioedema Ankylosing Spondylitis Anti-Aging & Cell Health Anti-Inflammatory Antioxidant Anxiety Apotic Dermatitis Arrhythmia (Irregular Heartbeat) Arteriosclerosis Arthritis Asthma & Breathing Difficulty Astigmatism Atherosclerosis & Arterial Disease Attention Deficit Disorder (ADHD) Autism Autoimmune Urticaria Bacterial Infection Bacterial Infections Barratt osophergous Benign Tumors / Cysts Bipolar Disorder / Manic-Depression Birth Control Bladder Disorder Bleeding disorder Brain Trauma Breast Cancer Bronchitis Burn Injury Cancer Celiac Disease Chronic Fatigue Syndrome Chronic Kidney Disease Chronic Obstructive Pulmonary Disease (COPD) Circulation Cirrhosis of the liver Cold Cold Constipation Crohn's Disease Cushing's Syndrome Cystic Fibrosis Depression Dermatomyositis Detoxification Diabetes Type 1 Diabetes Type 2 Diarrhea & Bowel Disorder Digestive Aids Displasia Drug Addiction Ear Infection Eating Disorder Eczema Edema Enlarged Prostate (BHP) Epilepsy Epilepsy, Seizure & Spasm Erectile Dysfunction (ED) Eye & Vision Problem Fever Fibromyalgia Flu Fungal Infection Gastrius Gastrointestinal & Stomach Problem Gastroparesis Gingivitis Glaucoma Gliomas Gout Hair Loss / Thinning Harth pain Hashimoto's Hypothyroidism Hay Fever Headache Heart Attack Heart Disease Hemorrhage (Blood Loss) Hemorrhoids Hepatitis B Hepatitis C Herpes High blood pressure High Blood Pressure (Hypertension) High Cholesterol HIV / AIDS Hormone Imbalance Hperkemia Hughes syndrome Human Papillomavirus (HPV) Huntington's Disease Hyperparathyroid hypercalcemia Hyperthyroidism Hypothyroidi Continue reading >>

Sitagliptin: A Review Of Its Use In Patients With Type 2 Diabetes Mellitus.

Sitagliptin: A Review Of Its Use In Patients With Type 2 Diabetes Mellitus.

Sitagliptin: a review of its use in patients with type 2 diabetes mellitus. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand, [email protected]. Drugs. 2014 Feb;74(2):223-42. doi: 10.1007/s40265-013-0169-1. Sitagliptin (Januvia(), Xelevia, Glactiv(), Tesavel()) is an orally administered, potent and highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4) and was the first agent of its class to be approved for use in the management of adults with type 2 diabetes. Numerous randomized placebo- or active comparator-controlled trials have demonstrated the efficacy of sitagliptin in terms of improving glycaemic control in patients with type 2 diabetes, including its use as monotherapy, initial combination therapy (usually with fixed-dose combinations of sitagliptin/metformin), or add-on therapy to metformin or to other antihyperglycaemic drugs, with or without metformin. The primary endpoint of the clinical trials was the reduction from baseline in glycosylated haemoglobin (HbA1c), although sitagliptin also showed beneficial effects for other endpoints, such as the proportion of patients who achieved target HbA1c, and reductions from baseline in fasting plasma glucose (FPG) levels and 2-h postprandial glucose (PPG) levels. Sitagliptin was generally well tolerated in clinical trials, had a low risk of hypoglycaemia (although this depends on background therapy) and had a neutral effect on body weight. Despite concerns regarding a possible increased risk of rare pancreatic adverse events (e.g. pancreatitis) with glucagon-like peptide-1 (GLP-1)-based therapies, such as GLP-1 receptor agonists and DPP-4 inhibitors, no causal association has been found; regulators in Europe recently conducted a review of available data, conc 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 >>

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 >>

Januvia Smackdown

Januvia Smackdown

Get your ringside seats, Folks! A while back I posted about the Merck's new Type 2 oral drug Januvia (What It Doesn't Do), explaining how it apparently trumps competitors in terms of patient "tolerability." No other post has ever generated such ongoing reader energy, both positive and negative. Nearly every day, several new commentors weigh in, duking it out over the relative merits of Januvia. Most everyone seems to agree that Januvia reduces appetite, which is a good thing. But then again, Byetta is known for that effect as well. The key is question whether Januvia fulfills its core function of lowering blood glucose (BG) levels, and lives up to its no-side-effects promise. As of today, the score stands pretty much tied, as such: Total comments = 50 Positive = 10 Negative = 13 Mixed = 16 (liked some aspects of the drug but not others) Neutral = 11 (those asking or responding to questions only) Among the most vocal of the Pro Team: "I take Januvia and have for 6 months. I have no side effects. I have experienced a decrease in appetite. I have had no headaches or respiratory problems. My BG has gone down. It is a great drug." -- Mike "Januvia has been a positive thing for me. My sugar levels dropped from 240+ to 110 +/- 10 after fasting. I have taken 100 mg once per day for a month... I am not as hungry as before usage." -- Jim K. L. "I've been on Januvia for a little over three months and have lost over 15 pounds which I had put on with Actos. I've experienced no side effects, other than I am not hungry all of the time. For me it has been very effective..." -- Bill "I am substantially less hungry then I have felt in years ... and my BG hovers around 100 - 120 between meals/fasting, and 120 - 160 for a few hours after a heavy carb meal. The usual BG spikes of 180 - 200+ Continue reading >>

Confab Reviews Safety Of Diabetes Drugs Like Merck's Januvia, Novo's Victoza

Confab Reviews Safety Of Diabetes Drugs Like Merck's Januvia, Novo's Victoza

Confab reviews safety of diabetes drugs like Merck's Januvia, Novo's Victoza Pressure is building to take a deeper dive into the cancer risks of incretin mimetics, a group of drugs for Type 2 diabetes that includes blockbusters like Merck's ($MRK) Januvia and Novo Nordisk's ($NVO) Victoza. A study of insurance records in March raised the specter of higher pancreatic cancer risks, and the FDA has been taking a closer look at the data. Drugmakers are meeting this week with officials of the FDA and the National Institutes of Health to present safety data for their drugs and to discuss what further study may be needed. FDA spokeswoman Morgan Liscinsky told Bloomberg that one possibility is a large clinical trial designed to show patterns of adverse events. Robert Ratner, chief scientific and medical officer of the American Diabetes Association, said: "We need some calm heads and to look at the data and try and make some reasonable judgments out of this." Potential risks for incretin mimetics, which help regulate blood sugar by stimulating insulin production, were identified years ago, not long after Byetta from Bristol-Myers Squibb ($BMY) hit the market. Their labels already carry warnings for risks of pancreatitis, added after Byetta was tied to 6 patient deaths. But in February a study published in JAMA Internal Medicine found that patients hospitalized with pancreatitis were twice as likely to be using Januvia or Byetta compared to diabetics who didn't have pancreatitis. And pancreatitis is linked to pancreatic cancer. That prompted the FDA to look again. Liscinsky told Bloomberg in an email that FDA researchers have not found a direct link between the use of incretin mimetics and pancreatitis, pancreatic cancer or thyroid cancer. "There have been several hypothesis gen Continue reading >>

More in diabetic diet