Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density

Sunday (9/13) - FDA has shown an issue that may be useful specifically for endocrinologist, nursing, and family practice. The organization has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures, and added new information about decreased bone mineral density. To address these safety concerns, FDA added a new WARNING AND PRECAUTION and revised the ADVERSE REACTIONS section of the Invokana and Invokamet drug labels.

FDA is continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapagliflozin (Farxiga, Xigduo XR) and empaglifozin (Jardiance, Glyxambi, Synjardy), to determine if additional label changes or studies are needed. Health care professionals and patients are urged to report side effects involving canagliflozin or other SGLT2 inhibitors to the FDA MedWatch program.

Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet. Bone mineral density relates to the strength of a person’s bones. 

Health care professionals should consider factors that contribute to fracture risk prior to starting patients on canagliflozin. Patients should talk to their health care professionals about factors that may increase their risk for bone fracture. Patients should not stop or change their diabetes medicines without first talking to their health care professional. 

For more information, please click here is disini 

Source: Drugs.com , FDA Alerts (http://www.drugs.com/fda/invokana-invokamet-canagliflozin-safety-communication-new-bone-fracture-risk-decreased-bone-mineral-13763.html?utm_source=ddc&utm_medium=email&utm_campaign=FDA+Alert+-+Drug+Safety+Communication%3A+Invokana+and+Invokamet+%28canagliflozin%29+-+New+Information+on+Bone+Fracture+Risk+and+Decreased+Bone+Mineral+Density)

Telemedicine: Opportunities and Challenges

Sunday (9/13) - An Everbridge white paper shows. Physicians face an increasing array of non-clinical demands on their time — in some practices doctors spend as much time working on documentation and sorting through insurance denials as they do seeing their patients. With the expansion of both private healthcare insurance and Medicaid in many states under the provisions of the Patient Protection and Affordable Care Act (ACA), demand for healthcare services has increased while the amount of time doctors have to see new patients has been reduced. 

      

       Patients, too, face long wait times at their physicians’ offices, often for minor ailments or routine follow-ups. Because consultations can be difficult to schedule, patients often skip follow-up visits or turn to online medical services and websites that may not provide reliable information. This not only erodes the doctor-patient relationship, but also potentially puts the patients’ health at risk.

 

       Telemedicine solutions can help physicians provide more convenient, real-time interactions with their patients while simultaneusly relieving the scheduling pressure on the physician practice. Telemedicine (sometimes referred to as telehealth) is a suite of technology solutions that enable doctors to communicate with and treat patients via text, video, and remote monitoring, while also enabling improved communication with other physicians and staff. 

 

For more information, please click here is disini 

 

Source: whitepapers.himssmedia.com (http://whitepapers.himssmedia.com/sites/whitepapers.himssmedia.com/files/Telemedicine_Opportunities_and_Challenges.pdf?aliId=193879869)

Is it okay to eat fish every day?

Sunday (9/13) - Is it okay to eat fish everyday? A news from Harvard T.H. Chan School of Public Health shows. Government dietary guidelines recommend that people eat fish twice a week. And we know that fish are full of omega-3 fatty acids—which can benefit both heart and brain. But is it safe to eat fish every day? “For most individuals it’s fine to eat fish every day,” says Eric Rimm, professor of epidemiology and nutrition, in an August 30 article on Today.com, adding that “it’s certainly better to eat fish every day than to eat beef every day.”

While it might be safe to eat fish every day, Rimm says it’s still not clear if there is any added health benefits to that level of consumption. “Most of the science isn’t looking at daily consumption,” he explains. “But many, many studies have shown that those who have it a couple of times a week have a lower rate of fatal heart attacks compared to those who don’t eat any.”

There are some exceptions, Rimm cautions. For example, pregnant woman and children should avoid larger fish with longer lifespans—like swordfish and tuna—because those can have higher levels of toxins, such as mercury. There are also environmental considerations—including the risk of over-fishing certain species. “Even to get people eating fish two times a week we need to ramp up fish farming,” Rimm says, noting that some types of farmed fish can be more nutritious than those caught in the wild.

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Source: hsph.harvard.edu, News, In The News, September 2015 (http://www.hsph.harvard.edu/news/hsph-in-the-news/is-it-okay-to-eat-fish-every-day/?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Nutrition%20Source%20-%20September%202015%20%281%29&utm_content=)

Women of Digital Health

THURSDAY, 3rd September 2015 - I think news that covers about women who plays big role in this age of digital health is needed. Here's I share what Johns Hopkins University Global mHealth Initiative representative, Olivia Velez, interviewing Kirsten Gagnaire, the Global Director of the Mobile Alliance for Maternal Action (MAMA). Very fruitful interview .

For more information, please click here is disini

Source: jhumhealth.org ,Interviews, September 2015 (http://www.jhumhealth.org/#!interviews/c208q)

Could Common Diabetes Drugs Help Fight Leukemia?

WEDNESDAY Sept. 2, 2015, 2015 -- Common diabetes drugs might help eradicate drug-resistant cancer cells in a certain form of leukemia when added to standard treatment, a small new study suggests.

Researchers found that patients with chronic myeloid leukemia (CML) who received a glitazone -- a class of drug for type 2 diabetes -- along with the standard CML drug imatinib remained disease-free for up to nearly five years.

Imatinib, known commercially as Gleevec, boasts an impressive track record in controlling chronic myeloid leukemia and allowing patients to lead virtually normal lives. But despite its effectiveness, dormant, drug-resistant leukemic cells typically lay in wait in bone marrow. They can later transform into highly aggressive cells.

"Gleevec can control the disease but never get rid of the source of the disease," said Lee Greenberger, chief scientific officer for the Leukemia & Lymphoma Society, who wasn't involved in the new research.

"But adding in these glitazones, [the research] claims you can eliminate the disease entirely," said Greenberger. "These are still early days for this work, however."

Actos and Avandia are two well-known glitazones.

Chronic myeloid leukemia is a cancer that originates in the blood-forming cells of the bone marrow and invades the blood supply. More than 6,600 cases are expected to be diagnosed in the United States this year, and about 1,140 people will die from the condition, according to the American Cancer Society.

Seen mostly in adults, chronic myeloid leukemia tends to be slow-growing, but can transform into a rapidly growing form that can quickly kill.

Together with his team, study author Dr. Philippe Leboulch, a professor of medicine and cell biology at the University of Paris, temporarily administered pioglitazone in addition to imatinib to three patients with chronic myeloid leukemia. Both drugs are available in pill form. Pioglitazone is marketed as Actos.

Although imatinib and other so-called tyrosine kinase inhibitors have significantly improved outcomes for this type of blood cancer, leukemia stem cells can develop a resistance to this standard treatment because of the dormant malignant cells in bone marrow.

In the study -- published online Sept. 2 in the journal Nature -- Leboulch described the molecular pathway leading to "quiescence," or cell dormancy, in chronic myeloid leukemia. The study suggested that glitazones can block this pathway, and, when used with imatinib, render patients disease-free for months to years after glitazones are discontinued.

It's unclear how the dormant, drug-resistant leukemia cells were killed using this combination therapy. But an editorial accompanying the study said the cells are "probably either killed directly or driven to exit quiescence, which may lead to their eradication by [imatinib]."

Dr. Jeffrey Schriber, a hematologist with Arizona Oncology in Scottsdale, said larger trials of this combination treatment are in progress and should yield results within the next three to five years.

But since drugs such as imatinib already enable 94 percent of chronic myeloid leukemia patients to remain alive five years after diagnosis -- with only 2 percent dying of the disease in that time -- adding in glitazones is "unlikely to make a significant difference" compared to current results, he said.

"From a scientific standpoint, however, the principles are critical and go beyond the therapy of CML," added Schriber, who specializes in the field of stem cell transplantation. "This principle could also be potentially applied to other leukemias where the results are not nearly as promising," he said.

The major weakness in the new study is its small size, Schriber said, making it difficult to know if the results would hold up in a larger group. Greenberger said it would be ideal to run a randomized controlled trial directly comparing the effectiveness of combination therapy (imatinib and a glitazone) versus imatinib alone.

Patients can take glitazones for months without serious side effects, Greenberger said.

"It would be best to see over years if [the combination therapy] could molecularly remove this disease," he said.

For more information, please click here is disini

Source: Drugs.com Consumer News September 2015 (http://www.drugs.com/news/could-common-diabetes-help-fight-leukemia-58143.html?utm_source=ddc&utm_medium=email&utm_campaign=Today%27s+news+summary+-+September+2%2C+2015&utm_content=Could+Common+Diabetes+Drugs+Help+Fight+Leukemia%3F)

FDA Approves Pediatric Indication for Emend (aprepitant) Capsules in Combination with Other Antiemetic Agents

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Emend (aprepitant) capsules, a substance P/neurokinin 1 (NK1) receptor antagonist. With this expanded indication, Emend capsules are now approved for use in combination with other antiemetic agents in patients 12 years of age and older and patients less than 12 years who weigh at least 30 kg (approximately 66 pounds) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin, as well as for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Emend has not been studied for treatment of established nausea and vomiting. Chronic continuous administration of Emend is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.
With this approval, Emend is the first and only NK1 receptor antagonist to be approved for the prevention of acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV) in patients 12 to 17 years of age and patients less than 12 years who weigh at least 30 kg receiving HEC or MEC. The approval was supported by data from a pivotal Phase 3 study that showed adding Emend to a standard regimen for prevention of CINV in HEC or MEC regimens resulted in a reduction of emetic events.
Emend is contraindicated in patients with any known sensitivity to any component of this drug. Emend is also contraindicated for patients taking pimozide.
There is no commercially available dosage formulation of Emend appropriate for patients less than 12 years of age and weighing less than 30 kg. Therefore, Emend is indicated for the prevention of nausea and vomiting associated with HEC or MEC in patients 12 years of age and older and patients less than 12 years of age who weigh at least 30 kg.

For more information, please click here is disini

Source: Drugs.com New Drugs, Septemeber 2015 (http://www.drugs.com/newdrugs/fda-approves-pediatric-indication-emend-aprepitant-capsules-combination-other-antiemetic-agents-4255.html?utm_source=ddc&utm_medium=email&utm_campaign=Today%27s+news+summary+-+September+2%2C+2015&utm_content=FDA+Approves+Pediatric+Indication+for+Emend+%28aprepitant%29+Capsules+in+Combination+with+Other+Antiemetic+Agents)

The Health, Technology, and World Around

Hi,

First of all, I would like to thank you for all my followers on twitter (@yudhaism) who already follow, retweet, and favorite information I have share before. In this sides, I like to share about information regarding to health, technology, and may some information on business and humanitarian action. It's not originally from me. You can scroll down in my timeline if you would like to know more. Some of them might just a comment on a tweet. But I really hope the information could help to inspire you to do whatever positive things you wanna do. Alright, so let's get started!