The National Institute of Mental Health (NIMH) and the American Psychiatric Association (APA), which publishes the DSM, issued a clarifying statement Tuesday saying that they were working together to ensure that people with mental disorders would have better diagnostic resources available to them. However, while they emphasized that the new version, dubbed the “DSM-5,” will have the most up-to-date information for clinical diagnoses of mental disorders, the NIMH did not waver from its initial ruling that it would no longer use diagnoses listed in the DSM for its’ funded studies.
NIMH director Thomas Insel wrote in a statement earlier in May that the NIMH felt the proposed definitions for psychiatric disorders were too broad and ignore smaller disorders that were lumped in with a larger diagnosis.

Read more: CBS News

The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013.

Xofigo is being approved more than three months ahead of the product’s prescription drug user fee goal date of Aug. 14, 2013, the date the agency was scheduled to complete review of the drug application. The FDA reviewed Xofigo under the agency’s priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.

“Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer.”

In August 2012, the FDA approved Xtandi to treat men with metastatic castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Xtandi is approved for patients who have previously been treated the chemotherapy drug docetaxel.

Xofigo’s safety and effectiveness were evaluated in a single clinical trial of 809 men with symptomatic castration-resistant prostate cancer that spread to bones but not to other organs. Patients were randomly assigned to receive Xofigo or a placebo plus best standard of care.

The study was designed to measure overall survival. Results from a pre-planned interim analysis showed men receiving Xofigo lived a median of 14 months compared to a median of 11.2 months for men receiving placebo. An exploratory updated analysis conducted later in the trial confirmed Xofigo’s ability to extend overall survival.

The most common side effects reported during clinical trials in men receiving Xofigo were nausea, diarrhea, vomiting and swelling of the leg, ankle or foot. The most common abnormalities detected during blood testing included low levels of red blood cells (anemia), lymphocytes (lymphocytopenia), white blood cells (leukopenia), platelets (thrombocytopenia) and infection-fighting white blood cells (neutropenia).

Xofigo is marketed by Wayne, N.J.-based Bayer Pharmaceuticals. Xtandi is co-marketed by Astellas Pharma U.S., Inc. of Northbrook, Ill., and Medivation, Inc. of San Francisco, Calif.

Source: FDA

Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses. Previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), Simponi is now approved to treat adults with moderate to severe ulcerative colitis that is resistant (refractory) to prior treatment or requires continuous steroid therapy.

Ulcerative colitis is a chronic disease that affects about 620,000 Americans. It causes inflammation and ulcers in the inner lining of the large intestine and is one of two main forms of chronic inflammatory bowel disease. The inflammation can lead to abdominal discomfort, gastrointestinal bleeding, production of pus and diarrhea.

“Simponi is an important new treatment option for patients with moderate to severe ulcerative colitis,” said Andrew E. Mulberg, M.D., deputy director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “It is critical that patients suffering from the serious and painful symptoms of ulcerative colitis have additional treatment options since patients experience the effects of the disease and respond to treatments differently.”

The safety and effectiveness of Simponi for ulcerative colitis were established in two clinical studies. Evaluations of patients included measures of stool frequency, rectal bleeding, endoscopic findings and a physician’s overall assessment.

In the first study, 513 patients with moderate to severe ulcerative colitis who could not tolerate or failed to respond to other therapies were randomly assigned to receive Simponi or a placebo. Results showed that a greater proportion of Simponi-treated patients achieved clinical response, clinical remission and, as seen during endoscopy, had improved appearance of the colon after six weeks compared with the placebo group.

In the second study, 310 patients with moderate to severe ulcerative colitis who were responders to Simponi were randomly assigned to receive Simponi or placebo. A greater proportion of Simponi-treated patients maintained clinical response through week 54 and had clinical remission at both weeks 30 and 54.

The most common side effects in patients treated with Simponi are upper respiratory infection and redness at the site of injection. Patients treated with Simponi are at increased risk of developing serious infections, invasive fungal infections, reactivation of Hepatitis B infection, lymphoma, heart failure, nervous system disorders and allergic reactions.

Simponi is marketed by Horsham, Penn.-based Janssen Biotech, Inc.

“Prospective mothers should take common sense preventive measures, such as getting flu shots prior to and in the early stages of pregnancy and avoiding contact with people who are symptomatic,” said Alan Brown, M.D., M.P.H, of Columbia University and New York State Psychiatric Institute, a grantee of the NIH’s National Institute of Mental Health (NIMH). “In spite of public health recommendations, only a relatively small fraction of such women get immunized. The weight of evidence now suggests that benefits of the vaccine likely outweigh any possible risk to the mother or newborn.”

Brown and colleagues reported their findings online May 8, 2013 in JAMA Psychiatry.

Although there have been hints of a maternal influenza/bipolar disorder connection, the new study is the first to prospectively follow families in the same HMO, using physician-based diagnoses and structured standardized psychiatric measures. Access to unique Kaiser-Permanente, county and Child Health and Development Study External Web Site Policy databases made it possible to include more cases with detailed maternal flu exposure information than in previous studies.

Among nearly a third of all children born in a northern California county during 1959-1966, researchers followed 92 who developed bipolar disorder, comparing rates of maternal flu diagnoses during pregnancy with 722 matched controls.

The nearly fourfold increased risk implicated influenza infection at any time during pregnancy, but there was evidence suggesting slightly higher risk if the flu occurred during the second or third trimesters. Moreover, the researchers linked flu exposure to a nearly sixfold increase in a subtype of bipolar disorder with psychotic features.

A previous study, by Brown and colleagues, in a related northern California sample, found a threefold increased risk for schizophrenia associated with maternal influenza during the first half of pregnancy. Autism has similarly been linked to first trimester maternal viral infections and to possibly related increases in inflammatory molecules.

This colorized transmission electron micrograph shows H1N1 influenza virus particles. Surface proteins on the virus particles are shown in black. Source: NIAID.

“Future research might investigate whether this same environmental risk factor might give rise to different disorders, depending on how the timing of the prenatal insult affects the developing fetal brain,” suggested Brown.

Bipolar disorder shares with schizophrenia a number of other suspected causes and illness features, the researchers note. For example, both share onset of symptoms in early adulthood, susceptibility genes, run in the same families, affect nearly one percent of the population, show psychotic behaviors and respond to antipsychotic medications.

Increasing evidence of such overlap between traditional diagnostic categories has led to the NIMH Research Domain Criteria (RDoC) project, which is laying the foundation for a new mental disorders classification system based on brain circuits and dimensional mechanisms that cut across traditional diagnostic categories.

The research was also funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Source: National Institutes of Health (NIH)

Researchers asked men and women to let their minds wander, then played a recording of white noise interspersed with the sounds of an infant crying. Brain scans showed that, in the women, patterns of brain activity abruptly switched to an attentive mode when they heard the infant cries, whereas the men’s brains remained in the resting state.

“Previous studies have shown that, on an emotional level, men and women respond differently to the sound of an infant crying,” said study co-author Marc H. Bornstein, Ph.D., head of the Child and Family Research Section of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the institute that conducted the study. “Our findings indicate that men and women show marked differences in terms of attention as well.”

The earlier studies showed that women are more likely than men to feel sympathy when they hear an infant cry, and are more likely to want to care for the infant.

Dr. Bornstein collaborated with Nicola De Pisapia, Ph.D., Paola Rigo, Simona DeFalco, Ph.D., and Paola Venuti, Ph.D., all of the Observation, Diagnosis and Education Lab at the University of Trento, Italy, and Gianluca Esposito, Ph.D., of RIKEN Brain Science Institute, Japan.

Their findings appear in NeuroReport.

Dr. Bornstein says this research not only helps understand the specific wiring of the brain, but helps understand how the brain has developed. (MP3 – 00:01:12, 1,140 KB)

Transcript – Dr. Bornstein says this research not only helps understand the specific wiring of the brain, but helps understand how the brain has developed.

Previous studies have shown differences in patterns of brain activity between when an individual’s attention is focused and when the mind wanders. The pattern of unfocused activity is referred to as default mode, Dr. Bornstein explained. When individuals focus on something in particular, their brains disengage from the default mode and activate other brain networks.

For about 15 minutes, participants listened to white noise interspersed with short periods of silence and with the sounds of a hungry infant crying. The patterns of their brain activity were recorded by a technique known as functional magnetic resonance imaging.

The researchers analyzed brain images from 18 adults, parents and nonparents. The researchers found that when participants listened to the typical infant cries, the brain activity of men and women differed. When hearing a hungry infant cry, women’s brains were more likely to disengage from the default mode, indicating that they focused their attention on the crying. In contrast, the men’s brains tended to remain in default mode during the infant crying sounds. The brain patterns did not vary between parents and nonparents.

Infants cry because they are distressed, hungry, or in need of physical closeness. To determine if adults respond differently to different types of cries, the researchers also played the cries of infants who were later diagnosed with autism. An earlier study of Dr. Bornstein and the same Italian group found that the cries of infants who develop ASD tend to be higher pitched than those of other infants and that the pauses between cries are shorter. In this other study, both men and women tended to interrupt their mind wandering when they heard these cries.

“Adults have many-layered responses to the things infants do,” said Dr. Bornstein. “Determining whether these responses differ between men and women, by age, and by parental status, helps us understand instincts for caring for the very young.”

In an earlier study, Dr. Bornstein and his colleagues found that patterns of brain activity in men and women also changed when they viewed an image of an infant face and that the patterns were indicative of a predisposition to relate to and care for the infant.

Such studies documenting the brain activity patterns of adults represent first stages of research in neuroscience understanding how adults relate to and care for infants, Dr. Bornstein explained. It is possible that not all adults exhibit the brain patterns seen in these studies.

Source: National Institutes of Health (NIH)

After volunteers consent online to participate in Type 1 Diabetes TrialNet — a study aimed at discovering ways to delay or prevent type 1 diabetes – they receive a screening kit in the mail, as shown, and will be directed to a local lab for a blood test at no cost to the volunteer. Courtesy of University of South Florida.

The screening, consisting of a questionnaire and blood test, is for Type 1 Diabetes TrialNet, a National Institutes of Health-funded long-term international collaboration. The collaboration is aimed at discovering ways to delay or prevent type 1diabetes in people at increased risk. TrialNet must screen more than 20,000 relatives of people with type 1 diabetes each year to perform studies to reach its research goals.

Previously, relatives needed to visit a study site or attend a screening event. But now, after answering a few questions online, eligible volunteers will receive a kit and be directed to a local lab for screening at no cost to the volunteer.

People who have antibodies associated with the development of type 1 diabetes will be contacted by a TrialNet center to review the results. They may be invited to have more blood tests at a study center, and may be invited to join a study aimed at preventing or delaying the disease. Children under 18 years old who do not have the antibodies can be retested annually to see if their risk has changed. Of every 100 people tested, typically only 3 or 4 will have antibodies showing an increased risk for type 1 diabetes.

“By ensuring the safety of people’s personal information while also making it easier to participate in clinical trials, we hope to find more people who are at risk and want to help find ways to delay or prevent type 1 diabetes,” said TrialNet Program Director Ellen Leschek, M.D., of the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which oversees the trial.

Type 1 diabetes, once called juvenile diabetes, develops when the body’s immune system mistakenly destroys the insulin-producing beta cells of the pancreas. Insulin, a hormone, is needed to convert glucose (sugar) into energy. People with type 1 diabetes need insulin by daily injections or a pump to survive. However, replacing insulin is not a cure, and the disease may eventually damage the eyes, nerves, kidneys, and blood vessels. In adults, type 1 diabetes accounts for about 5 percent of the approximately 19 million people diagnosed with diabetes. Type 1 diabetes is not associated with obesity.

TrialNet studies have already helped. People at risk for type 1 diabetes who participated in TrialNet’s Pathway to Prevention Study were more likely to be diagnosed early.

“For people with type 1 diabetes, the importance of early diagnosis cannot be overstated,” said NIDDK Director Griffin P. Rodgers, M.D. “Early diagnosis means people are less likely to develop diabetic ketoacidosis, a life-threatening condition. Early diagnosis also means people can often control their diabetes more quickly, which may slow the loss of insulin-producing cells and may delay complications.”

Launched in 2001, TrialNet has also demonstrated that two drugs, Rituximab and Abatacept, slow the loss of insulin production in people with new-onset type 1 diabetes. This finding could improve diabetes control and delay complications. TrialNet has also contributed to research showing that anti-CD3, an immunosuppressive drug, can slow loss of insulin production. Three prevention studies are ongoing.

TrialNet is a network of 18 clinical centers working in cooperation with more than 200 sites throughout the United States, Canada, Finland, Britain, Italy, Germany, Australia and New Zealand. TrialNet is funded by NIDDK and other NIH components, including the National Institute of Allergy and Infectious Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, as well as the Juvenile Diabetes Research Foundation and American Diabetes Association.

The FDA does not require food facilities to implement food defense plans, but many facilities have voluntarily put such plans into place to safeguard their products.

“The FDA is committed to providing best practices and resources to support industry as we pursue our shared goal of protecting our food supply,” said FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor. “We strongly encourage companies to take full advantage of the Food Defense Plan Builder.”

Cases of intentional contamination are infrequent but can entail serious adverse public health consequences. For example, in 2009, more than 40 people in Kansas became ill after disgruntled restaurant employees intentionally contaminated salsa with a pesticide. In 1996, 12 lab workers at a Texas medical facility became ill after eating pastries that were intentionally contaminated with a virulent strain of Shigellabacteria.

The Food Defense Plan Builder is FDA’s latest effort to help owners and operators of food facilities take appropriate action to defend the food supply. In the years following the September 11, 2001 attacks, the FDA released a number of food defense tools and resources to aid the U.S. food industry, federal partners, state and local regulators, and the international community in protecting the food supply against biological, chemical and radiological attack.

The Food Defense Plan Builder guides users through a series of substantive questions about the user’s food facility and the food manufactured, processed, packed or held there to develop a comprehensive food defense plan for the facility, which includes a vulnerability assessment, broad and focused mitigation strategies, and an action plan.

The content in the tool is based on the FDA’s food defense guidance documents and as such, the Food Defense Plan Builder is consistent with the FDA’s current thinking on food defense preparedness. In addition to providing new functionality for food defense planning and implementation, the Food Defense Plan Builder harnesses existing FDA tools and resources into a single application. These tools and resources include the FDA’s food defense guidance documents, Vulnerability Assessment Software Tool, and Mitigation Strategies Database.

Learn more about the FDA’s Food Defense Plan Builder.

Source: FDA

A man is shown thinking about pictures of Michael Jackson and Marilyn Monroe in a conceptual rendering of the experiments in the study.

A recent study, published in Nature found that when research subjects had their brains connected to a computer displaying two merged images, they could force the computer to display one of the images and discard the other. The signals transmitted from each subject’s brain to the computer were derived from just a handful of brain cells.

“The subjects were able to use their thoughts to override the images they saw on the computer screen,” said the study’s lead author, Itzhak Fried, M.D., Ph.D., a professor of neurosurgery at the University of California, Los Angeles.

The study reflects progress in the development of brain-computer interfaces (BCIs), devices that allow people to control computers or other devices with their thoughts. BCIs hold promise for helping paralyzed individuals to communicate or control prosthetic limbs. But in this study, BCI technology was used mostly as a tool to understand how the brain processes information, and especially to understand how thoughts and decisions are shaped by the collective activity of single brain cells.

“This is a novel and elegant use of a brain-computer interface to explore how the brain directs attention and makes choices,” said Debra Babcock, M.D., Ph.D., a program director at NINDS.
Subjects Mentally Told a Computer to Focus on Michael or Marilyn.

A conceptual rendering of the experiments in the study by Cerf et al. in Nature. A man is shown thinking about pictures of Michael Jackson and Marilyn Monroe.

The study involved 12 people with epilepsy who had fine wires implanted in their brains to record seizure activity. Recordings like these are routinely used to locate areas of the brain that are responsible for seizures. In this study, the wires were inserted in the medial temporal lobe, a brain region important for memory and the ability to recognize complex images, including faces.

While the recordings from their brains were transmitted to a computer, the research subjects viewed two pictures superimposed on a computer screen, each picture showing a familiar object, place, animal or person. They were told to select one image as a target and to focus their thoughts on it until that image was fully visible and the other image faded away. The monitor was updated every one-tenth of one second based on the input from the brain recordings.

As a group, the subjects attempted this game nearly 900 times in total, and were able to force the monitor to display the target image in 70 percent of these attempts. Subjects tended to learn the task very quickly, and often were successful on the first try.

The brain recordings and the input to the computer were based on the activity of just four cells in the temporal lobe. Prior research has shown that individual cells in this part of the brain respond preferentially — firing impulses at a higher rate — to specific images. For instance, one cell in the temporal lobe might respond to seeing a picture of Marilyn Monroe, while another might respond to Michael Jackson. Both were among the celebrity faces used in the study.

Dr. Fried’s team first identified four brain cells with preferences for celebrities or familiar objects, animals or landmarks, and then targeted the recording electrodes to those cells. The team found that when subjects played the image-switching game, their success appeared to depend on their ability to power up cells that preferred the target image and suppress cells that preferred the non-target image.

“The remarkable aspects of this study are that we can concentrate our attention to make a choice by modulating so few brain cells and that we can learn to control those cells very quickly,”” said Dr. Babcock.

Prior studies on BCIs have shown that it is possible to perform other tasks, such as controlling a computer cursor, with just a few brain cells. However, the task here was more complex and might have been expected to involve legions of cells in diverse brain areas needed for vision, attention, memory and decision-making.

The study was funded in part by the National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH), both part of NIH.

Source: National Institutes of Health (NIH); “On-line, voluntary control of human temporal lobe neurons,” (Cerf M et al. ) in Nature, October 28, 2010

“Bundle Up or You’ll Catch Your Death”

Contrary to what your mother told you, and what you may have told your own kids, chilling and dampness have nothing to do with susceptibility to the common cold. Back in the 1950′s, at the Common Cold Research Unit in England, then-director Christopher Andrewes, M.D., made volunteers stand nearly naked in frigid meat lockers and drafty gyms wearing little but wet socks for hours on end, and in no experiment did those who got chilled catch more colds, or worse colds, than people who spent the same amount of time happily ensconced in warm cozy rooms.

The contemporary twist on the “chill” myth is that people who live in centrally air-conditioned homes or work in modern office buildings often blame their colds on over-active air-conditioners. The problem is not the air’s low temperature, Dr. Cooper says, but rather it’s low relative humidity. Air conditioning dries air, often to the point where it may dehydrate the protective mucus in the nasopharynx and allow cold viruses to do their worst.

Don’t Kiss Me. I Have a Cold

Dr. Dick infected one member of 16 couples with a cold virus, and had them to plant an extended kiss on their partners’ mouths. Only one partner (6 percent) caught the cold. During colds, the virus generally stays in the nose and throat. The mouth remains remarkably virus-free. Then Dick infected one member of 24 married couples and tracked them as they lived their daily lives together for more than a week. Only nine of the spouses (38 percent) caught the cold, and risk was unrelated to their kissing or lovemaking. The only risk factor was the total amount of time they spent together. There’s no reason to refrain from kissing cold sufferers, especially if the kiss is a peck on the cheek. “Just don’t rub noses with them,” Dick advises, “or you risk passing the cold by nose-to-nose transmission.”

“Feed a Fever, Starve a Cold.”

Or is it: “Starve a fever, stuff a cold”? You hear it both ways, but don’t starve or stuff either one. Drown colds in plenty of fluids, Dr. Simons says. As for feeding and starving, colds often suppress appetite, and some people say that eating lightly or drinking only vegetable juices speeds their recovery. Listen to your body. Eat well if you feel hungry. Refrain if you don’t.

I have a Cold, Doc. I need an Antibiotic

Not so fast. Antibiotics treat only bacteria. They are powerless against viruses, including the viruses that cause colds. Antibiotics can help only when you have a bacterial infection, for example, sinusitis, on top of your cold. Such secondary bacterial infections occur in only about 10 percent of colds, according to a study by Ralph Gonzalez, M.D., of the University of Colorado Health Sciences Center in Denver. Doctors know this, but come under pressure for antibiotics from their patients—and wind up writing some 12 million antibiotic prescriptions a year for colds and other viral infections. These unnecessary prescription add to health care costs and contribute the development of antibiotic-resistant micro-organisms.

The U.S. Food and Drug Administration (FDA) today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.

About 20 million people in the United States have type 2 diabetes, and they often have high cholesterol levels as well. These conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness, among other chronic conditions, particularly if left untreated or poorly treated.

Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body’s own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Simvastatin is an HMG-CoA reductase inhibitor, or statin, approved for use with diet and exercise to reduce the amount of “bad cholesterol” (low-density lipoprotein cholesterol or LDL-C) in the blood.

“This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet,” said Mary H. Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “However, to ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients. Dose selection should factor in what other drugs the patient is taking.”

This FDC is based on substantial experience with both sitagliptin and simvastatin, and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately. Juvisync is a convenience combination and should only be prescribed when it is appropriate for a patient to be placed on both of these drugs.

Juvisync was approved in dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. The company has committed to develop FDC tablets with the sitagliptin 50 mg dose, as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg. Pending availability of the FDC tablets containing 50 mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet. There is no plan to develop FDCs with the sitagliptin 25 mg dose as use of this dose is quite low.

Simvastatin is currently marketed in dosage strengths of 5, 10, 20, 40, and 80 mg. Due to recent restrictions placed on the use of the 80 mg dose because of a higher risk of muscle toxicity, there will not be a FDC using this dose. There is also no plan to develop FDCs with the simvastatin 5 mg dose as use of this dose is quite low as well.

The FDA has recently become aware of the potential for statins to increase blood sugar levels in patients with type 2 diabetes. This risk appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes. However, the prescribing information for Juvisync will inform doctors of this possible side effect. The company will also be required to conduct a post-marketing clinical trial comparing the glucose lowering ability of sitagliptin alone compared to sitagliptin given with simvastatin.

Juvisync is approved with a Medication Guide that provides important information to patients. The most common side effects of Juvisync include upper respiratory infection; stuffy or runny nose and sore throat; headache; muscle and stomach pain; constipation; and nausea.

Juvisync is manufactured by MSD International GmbH Clonmel, Co. in Tipperary, Ireland.

Source: FDA