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A new study reveals that antipsychotic medications, such as Risperdal (risperidone), which are being prescribed to a growing number of children, have been tied to serious side effects including increased risks for diabetes. The research from Vanderbilt University Medical Center was just published in JAMA Psychiatry and revealed that children and teenagers face a three-fold risk for developing Type 2 diabetes in the first year of Risperdal treatment. These recent findings are the result of a retrospective cohort study of the Tennessee Medicaid program, which included data on more than 40,000 patients and focused on patients who were recently diagnosed with diabetes after taking the atypical antipsychotic. The study involved people between the ages of six and 24; 29,000 were prescribed medications for attention, behavioral, and mood disorders.
Meanwhile, a probe had been initiated by the Office of the Inspector General (OIG) at the Department of Health and Human Services (DHHS) over the increased use of drugs such as Risperdal being prescribed to children. There are growing concerns over potential overuse of the medication to treat behavioral issues, especially in pediatric patients. INVOKANA™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Janssen also will offer a dedicated INVOKANA™ CarePath support program to patients and caregivers. The new drug application for INVOKANA™ was based on a comprehensive global Phase 3 clinical program, which enrolled 10,285 patients in nine studies and is one of the largest clinical programs in type 2 diabetes submitted to health authorities to date. Results from this program showed that the 100 mg and the 300 mg doses of INVOKANA™ improved glycemic control and, in prespecified secondary endpoints, were associated with significant reductions in body weight and systolic blood pressure. The Phase 3 studies for INVOKANA™ were presented at the American Diabetes Association (ADA) Annual Scientific Sessions in June 2012, at the European Association for the Study of Diabetes (EASD) Annual Meeting in October 2012, and at the World Congress on Controversies to Consensus in Diabetes, Obesity, and Hypertension (CODHy) in November 2012.
Janssen and its affiliates have rights to INVOKANA™ through a license agreement with Mitsubishi Tanabe Pharma Corporation. Approximately 60 percent of patients with type 2 diabetes in the United States are obese, while another 30 percent are overweight.
INVOKANA™ is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA™ is not for people with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA™ is safe and effective in children under 18 years of age.
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is one that is listed above.
If you take too much INVOKANA™, call your doctor or go to the nearest hospital emergency room right away. Your doctor may do certain blood tests before you start INVOKANA™ and during treatment as needed. Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Janssen Pharmaceuticals, Inc.
Our company provides medicines for an array of illnesses and disorders in several therapeutic areas.


This is not the first time that Risperdal side effects have been the focus of medical research, including ties between Risperdal and diabetes.
This group was compared to a group of more than 14,000 prescribed other psychiatric medications. Some antipsychotics have been approved for the treatment of children with behavioral issues, including bipolar disorder, and schizophrenia; others are prescribed off-label for non-approved uses.
Food and Drug Administration (FDA) advisory panel urged the FDA to monitor Risperdal side effects such as weight gain and metabolic disease risk in kids taking the medications, according to CBS News.
Concerns have also been raised over the risk of drugs, such as Risperdal, being used in young boys and the development of gynecomastia, a serious side effect in which boys develop breasts.
As glucose is filtered from the blood into the kidneys, it is reabsorbed back into the bloodstream.
INVOKANA™ has been studied as a single agent (monotherapy), in combination with metformin, and in combination with other glucose-lowering agents, including insulin, in patients who need further glucose control. The program provides important support and information regarding affordable access, adherence and education, thereby helping patients to start and appropriately manage their disease and therapy over time.
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with INVOKANA™ or any other antidiabetic medication. Centers for Disease Control and Prevention estimates that nearly 26 million Americans have diabetes, 90 to 95 percent of which is type 2 diabetes. In most people at risk for type 2 diabetes, obesity causes the body to resist the action of insulin, and if the pancreatic beta cell cannot produce enough insulin, hyperglycemia and type 2 diabetes ensue. INVOKANA™ can cause some people to have dehydration (the loss of body water and salt). Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis.
Low blood sugar can happen more often when INVOKANA™ is taken with certain other diabetes medicines. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Your doctor may change your dose of INVOKANA™ based on the results of your blood tests.
If you take INVOKANA™ with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA™ and call your doctor right away or go to the nearest hospital emergency room.
Aguilar was not associated with the INVOKANA™ clinical trials and was not compensated for any media work.
National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011.
The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988–2010.
The study reviewed both atypical and older generation antipsychotics and revealed that the risk did not differ. The psychological ramifications of gynecomastia are significant, and the disorder may involve double mastectomy to surgically remove the breasts.


Food and Drug Administration (FDA) has approved INVOKANA™ (canagliflozin) for the treatment of adults with type 2 diabetes. An important carrier responsible for this reabsorption is called sodium glucose co-transporter 2 (SGLT2).
A1C is the percent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months. Additional data are being collected to further characterize the cardiovascular profile of INVOKANA™.
Type 2 diabetes is a chronic condition that affects the body's ability to metabolize sugar, or glucose, and is characterized by the inability of pancreatic beta cell function to keep up with the body's demand for insulin1. Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension).
Talk to your doctor right away if you use an over-the-counter antifungal medication and your symptoms do not go away.
If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant. Talk with your doctor about the best way to feed your baby if you are taking INVOKANA™.
Tell your doctor right away if you have any of these conditions and follow your doctor's instructions.
The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKANA™. Driven by our commitment to patients, healthcare professionals, and caregivers, we strive to develop sustainable and integrated healthcare solutions by working in partnership with all stakeholders on the basis of trust and transparency. INVOKANA™ is the first in a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors to be approved in the United States.
INVOKANA™ selectively inhibits SGLT2, and as a result promotes the loss of glucose in the urine, lowering blood glucose levels in adults with type 2 diabetes. The most common adverse events with INVOKANA™ are genital mycotic (fungal) infections, urinary tract infections, and increased urination. In the two studies, the overall incidence of adverse events was similar with INVOKANA™ and the comparators.
Our daily work is guided by meeting goals of excellence in quality, innovation, safety, and efficacy in order to advance patient care. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc. It is also the only oral, once-daily medication available in the United States offering improved glycemic control while also showing reduced body weight and systolic blood pressure in clinical trials. These specific adverse events were generally mild to moderate in intensity and infrequently led to discontinuation in Phase 3 studies.



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