FDA Approves OxyContin For Children As Young As Eleven - http://clapway.com/2015/08/14/fda-approves-oxycontin-for-children-as-young-as-eleven123/

The Food and Drug Administration (FDA) has recently announced that they have approved the usage of OxyContin, a notoriously potent painkiller, for patients younger than ever before. Now, children aged between 11-16 will be able to have OxyContin prescribed to them by a doctor. It is a move that is sure to gain a far amount of controversy for the FDA. OxyContin, though an effective painkiller, is infamous for being highly addictive as a form of oxycodone. However, both the manufacturers of OxyContin and the FDA have gone out of their way to ensure people that steps have been taken to make this as safe a usage as  possible for children taking an opioid.

How The Decision Was Made To Allow Children OxyContin Prescriptions

This was not a decision that the FDA came to lightly. The FDA had Purdue Pharma, the manufacturers of OxyContin, conduct a study centered on the effects of opioid use on children. Opioids have not been a drug that has been commonly prescribed by pediatricians, but the study found that pediatric patients being treated for pain are capable of responding to OxyContin much in the same way adults can. Even with that in mind, though, the FDA will still require that doctors examine how the patient responds to, at minimum, a 20 milligram dose of opioid medication for five days.

The FDA is also reassuring concerned parents that the OxyContin prescriptions for children aged 11 through to 16 will be quite limited. OxyContin tends to be prescribed for a pain severity or frequency more common in adults than in children. As such, the examples thrown out as reasons to prescribe OxyContin for pediatric patients were extremes such as trauma, spinal surgery, or surgery to correct birth defects. And even then, OxyContin remains more of a possible option than a first choice.

Purdue Has Also Worked to Make OxyContin Safer

In the past few years, Purdue Pharma has made strides in working to combat addictive use of OxyContin. For example, in 2010 OxyContin was reformulated so that it could no longer be injected or crushed and snorted. With OxyContin becoming harder to abuse, intense studies being done, and regulations being set, the FDA decided that it was officially safe to allow for children with severe pain.

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FDA Approves OxyContin For Children As Young As Eleven

FDA Approves Cholesterol-Lowering Drug - http://clapway.com/2015/07/25/fda-approves-cholesterol-lowering-drug765/

Patients with uncontrollably high cholesterol can now receive proper medication, thanks to a cholesterol-lowering drug that could potentially have great benefits to cardiovascular care. The US Food and Drug Administration (FDA) recommended the approval of the drug in June, and finally gave the product the go-ahead on Friday.

THE FDA APPROVED THE PRALUENT INJECTION IN JUNE

The U.S. Food and Drug Administration has approved Praluent injection, which is the first cholesterol-lowering treatment approved in a “new class of drugs known as a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.”

THIS cholesterol-lowering drug CAN COST AROUND $1,200 FOR A MONTH’S SUPPLY

Sanofi and Regeneron announced the availability of the new medication to adult patients next week. The drug will come in two doses in a pre-filled pen, and patients can then administer it on their own, once every two weeks. A month’s supply of this medication will cost roughly $1,200. This cost will definitely depend upon the patients insurance plan.

The cholesterol-lowering drug was described by the American Heart Association president Dr. Elliot Antman as a powerful new way of lowering the bad form of cholesterol. He also added the importance of Praluent in having profound implications on the vascular diseases. This drug also helps the liver more efficiently rid the body of LDL cholesterol. LDL cholesterol, or low density lipoprotein, is considered to be the bad cholesterol because it contributes to the thick hard plaque-like deposit that can clog arteries and make them less flexible. This results in the condition known as atherosclerosis, that if a clot forms, can result in a heart attack or stroke.

THIS IS FOR PATIENTS WITH HEFH, WHICH RESULTS IN HIGH LDL CHOLESTEROL

This medication was approved by the FDA for patients who have heterozygous familial hypercholesterolemia, also known as HeFh. Hefh is an inherited condition that usually results in high levels of LDL cholesterol. It was also approved for patients who have had a stroke or a heart attack.

Researchers who tested Praluent in the Phase 3 ODDYSSEY program, and resulted in consistent results compared with statins and placebo. This program evaluated 150 mg of the drug every two weeks and found a 58 percent reduction of the LDL cholesterol levels in patients around the 24th week. Around 75 mg, Praluent resulted in a 44 percent of LDL cholesterol levels by the 24th week.

Another new cholesterol-lowering drug that serves the same purpose as Praluent, called Repatha, was also approved recommended to the FDA by the same committee. Europe has already approved the drug last week, but is still being considered for approval in the United States by the FDA.

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FDA Approves Cholesterol-Lowering Drug

House of Reps Passes New 21st Century Cures Act - http://clapway.com/2015/07/10/house-of-reps-passes-new-21st-century-cures-act569/

New Drug Regulations in House of Reps

On Friday, the US House of Representatives passed a bill, called the 21st Century Cures Act, that may speed up the process for drugs to make it to the market.

As reported by Reuters, this decision – coming at a vote of 344 to 77 – “will allow for new drugs to make it to the public market much quicker than the current regulations allow.” This will be done as per the Act’s requirements, specifying that the FDA to make their journey to the market occur smoothly, while opening the possibility of more inclusive regulations. Some guidelines that the Act includes are flexible clinical trials to test the safety and vitality of each drug, and the utilizing of patient experience in the final approval. The FDA’s current framework would be completely overhauled and recreated to fit the implementations of drug approval.

The 21st Century Cures Act was developed by the House Energy and Commerce Committee. A similar bill is expected to be voted on by the Senate later this year, and the success of the 21st Century Cures Act leaves open the possibility for its passing as well.

So, What Are the Regulations?

The House bill does come with specific regulations and guidelines for the FDA to follow in its new overhaul of drug approval methods. There would be an increase in funding for the National Institutes of Health by almost $9 billion over a five-year time period, while also increasing funding for the Food and Drug Administration. An upside to this would be the increased incentives for major pharmaceutical companies to create drugs that focus on specific and not-so-common diseases. There would also be a speedier timeframe for antibiotics to be approved, as it will have fewer testing trials to undergo.

21st Century Cures Act’s Effect on Healthcare Regulations

In short, this bill has the potential to shift how drug companies and the healthcare field interact with each other and their patients. And while many will be watching carefully to examine just how the 21st Century Cures Act will be utilized to best address patient concerns, there is still the hope that the passing of this bill, along with others, will allow for a better examination of solution addresses within the healthcare field.

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House of Reps Passes New 21st Century Cures Act

BrainPort Device Lets Blind People ‘See’ With Tongue, Gets FDA Approval - http://clapway.com/2015/06/20/brainport-v100-lets-blind-people-see-with-tongue-gets-fda-approval987/

A device that helps blind people ‘see’ with their tongues has recently earned FDA approval. The BrainPort V100, which had already been available in Europe since 2013, converts video imagery to electrotactile signals that paint a sort of picture of the world around the user. It took 15 years of research to develop the revolutionary device, and blind people in the United States can now benefit from it thanks to this recent development.

How does the BrainPort device work?

The BrainPort V100, created by Wisconsin company Wicab, uses a video camera to gather visual data. That visual data then gets translated into moderate electrical stimuli for the tongue. The device features a 400-electrode sensor array, allowing the electrical stimuli to paint a sort of feel-based image on the tongue. The electrodes as sort of like pixels, and can show locations of objects as well as their direction and speed. After some practice with the device, a blind user can use it to “see.”

69 percent of study sample population could identify objects thanks to the BrainPort device.

FDA testing showed that after a year of practice with the BrainPort V100, 69 percent of the 74 people in the study could “see” with their tongues based on an object recognition test. Word identification tests were also concluded. The only side effect of the device seems to be a slight amount of discomfort, according to the study. Some users reported a burning or stinging sensation, as well as a metallic taste from the device. Either way, the Brainport device poses no real risks to health, and a very valuable potential benefit to blind people all over the world.

 Where did the idea for the BrainPort V100 originate?

The idea behind this important new device came from Paul Bach-y-Rita, an American neuroscientist who championed the idea of using neuroplasticity to treat patients with disabilities. Neuroplasticity is the changing of neural pathways and synapses due to changes in thinking, emotions, environment, behavior, as well as those resulting from injury. Bach-y-Rita developed a chair in the 1960s that would translate visual images into tactile patterns on a patient’s back. He then came up with the technology for a new idea, a brain-tongue connection, thus paving the way for the BrainPort device to help blind people today.

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BrainPort Device Lets Blind People ‘See’ With Tongue, Gets FDA Approval