Young Girls Are Not Allowed on Tanning Beds because of FDA - http://clapway.com/2015/12/19/young-girls-are-not-allowed-on-tanning-beds-because-of-fda/

The FDA is officially fed up with the rise of skin cancer. They have proposed an official ban on anyone under the age of 18 using tanning beds. Not only this, but they also proposed for anybody who wants to use a tanning bed to sing a legal document. This document would spell out the risks of using tanning beds.

FDA BANS ANYONE UNDER 18 FROM USING TANNING BEDS

There have been many warnings in the past that have been issued by public health groups. However, the FDA is not warning, they are demanding. This proposal could come into effect as early as a couple of months. So, anyone under the age of 18 better get their fill soon because they might not be able to for a while.

THE FDA TO INCLUDE MANDATORY SIGNING OF A DOCUMENT

The FDA did not stop at just proposing a ban to stop anyone under the age of 18 to use a tanning bed. They are also including a document that must be signed by users partaking in this activity. This document will acknowledge all of the fatal risks that could occur when using tanning beds. All users will be required to sign this document before their first session. Then, after that, they will be required to re-sign the document every six months. This will ensure that tanning bed locations can not be held responsible if something was to happen to the person using them.

THE RISK OF TANNING BEDS

According to The American Academy of Dermatology, the risk of developing a tumor associated with skin cancer is drastically increased with tanning beds. They say that people who have been exposed to ultraviolet radiation see their chances of gaining skin cancer increased by 59 percent. Not only that but with each additional use your chances are even greater to develop skin cancer. Also, the FDA mentions how teens under 18 already have a greater risk of skin cancer when using tanning beds. These are eye-popping numbers and they prove that if you want a tan, just go out and lay in the sun!

FDA ALSO PROPOSES SAFETY FEATURE

The last item on the agenda for the FDA was to propose the implementation of panic buttons in all tanning beds. They said they want these implemented so if there is an emergency, they can be shut down immediately. The FDA has full intentions of making the world safer for not only teens but for anybody using tanning beds.

Young Girls Are Not Allowed on Tanning Beds because of FDA

FDA is Worried About Food Security - http://clapway.com/2015/12/05/fda-is-worried-about-food-security123/

The FDA has become increasingly concerned with the effect of climate change on food safety. A report from the COP21 climate talks in Paris has revealed that food safety in general is seeing declines in quality and security.

Food Safety Report Published by the US Global Change Research Program

According to the results, warmer temperatures have been altering rainfall. This makes food production on farms perilous. This also threatens the transportation systems used for food, storage, and general food security. Increasing greenhouse gas emissions is very obviously disturbing food production. These levels need to see an immediate decrease.

Food security entails the capability of people to get enough safe and healthy food. This is affected not only by climate change, but also by technological advances, increases in population levels, wealth distribution and nutritional trends. The research shows that climate change has a particularly negative effect in food production in tropical and subtropical regions like Africa and southern Asia.

Climate Change Could Also Bring Productivity Increase

Other regions in with temperate climates could see productivity increases. Changing climates can bring increased rainfall. But this won’t last very long. If gas emission levels aren’t reduced, this increased rainfall will become a negative instead of a plus. Worse comes to worse, the rate of undernourishment in the world will raise by 178 million by 2080. The current figure stands around 805 million.

The level of undernourishment finally saw a decline from 1 billion in 1990, but if climate change isn’t halted, it’s possible that we may see the figures return to over a billion once again. Changes in climate as well as society are pivotal for food security. Given these figures, bodies like the FDA will immediately want to get to work on collaborating with bringing down greenhouse gas emissions.

A Growing Process

The FDA, despite being a US authority, doesn’t have the power to act alone. Politics are at the core of this problem. If the Senate and the White House work together to cut back on gas emissions, food safety may not see such a downfall after all.

FDA is Worried About Food Security

FDA Approves New Drug to Treat Skin Cancer - http://clapway.com/2015/11/12/fda-approves-new-drug-to-treat-skin-cancer123/

The U.S. Food and Drug Administration has approved a new therapy treatment for skin cancer, specifically metastatic melanoma. The drug combination, which was partly developed at UCLA, has shown promise in treating this kind of skin cancer or melanoma without causing a secondary skin cancer.

This combination of drugs has a very high success rate particularly for patients with a BRAF mutated melanoma with lower risk of adverse side effects. The drugs have been tested at UCLA and in 135 other sites around the US, Europe, Australia and Russia.

Skin Cancer Treatments Are Scarce

The drug vemurafenib, also known as Zelboraf, was combined with cobimetinib, or Cotellic, and given to 495 patients with BRAF V600, a mutation-positive advanced skin cancer or melanoma. Patients saw such a tremendous improvement that the study was continued, and the FDA granted it Priority Review status, which led to the drug being approved.

These New Treatment Prevents Secondary Skin Cancer From Forming

Currently, 70,000 Americans are diagnosed with skin cancer or melanoma per year, and 8,000 of these people die from the disease. Half of the Americans diagnosed have a mutated proten called a BRAF mutation, which is treated with vemurafenib. By combining it with cobimentinib, not only does the drug therapy block the signal for the melanoma to grow as a cancer, but it can also prevent any other skin cancers from forming.

FDA Approves New Drug to Treat Skin Cancer

New Vaccine Lowers Bad Cholesterol - You Can Eat Fats - http://clapway.com/2015/11/12/new-vaccine-lowers-bad-cholesterol123/

A new vaccine that uses the protein PCSK9 has proven to lower bad cholesterol and even treat heart disease. When in combination to statins, the vaccine was proven to bring bad cholesterol to an even deeper drop.

According to the drug’s UPI report, the treatment was administered to both macaque monkeys and mice. The treatment is still in experimental change and an upgrade to human testing is not yet scheduled, but these promising developments could change the lives of millions of people who suffer of increased bad cholesterol.

The FDA recently approved two drugs recently that target this protein, but this is for patients with a very specific high bad cholesterol condition that is tied to genetics. These drugs are also extremely expensive, ranging between $7,000-$12,000 annually. The new vaccine has a stark difference in price. The results of these vaccines are striking and can bring a new treatment to people with high bad cholesterol with minimized side effects.

This new set of medications could target a large group of people of varying ages and could even help treat those with predisposition to high bad cholesterol, and hopefully human testing will bring good results and this drug can be on the market soon.

 

New Vaccine Lowers Bad Cholesterol - You Can Eat Fats

Gilead Sciences Moves for Japanese Market - http://clapway.com/2015/11/02/gilead-sciences-moves-for-japanese-market-123/

Despite its latest FDA scandal, Gilead Sciences filed a New Drug Application to Japan’s Ministry of Health, Labour and Welfare, who approved the company’s once daily oral tablet hepatitis C treatment.

Harvoni, the name of the mediation, along with Gilead’s other hepatitis C treatment regiment Sovaldi, represent about 60% of the company’s revenue, and they hope to see an increase in their stocks as this project moves forward.

The company expects a 9.3% increase in stocks, and analysts are speculating that this move may just be what puts Gilead back on the market. Harvoni and Sovaldi have always been Gilead’s saving graces, and being top of the line in class regimens, it was only to be expected that these two medications would be what saved them from the inevitable plummet caused by their most recent run-in with the US FDA.

 

Gilead Sciences Moves for Japanese Market

On Thursday, the #FDA approved #Repatha, the second drug in a large class of powerful #cholesterol lowering medicines - http://clapway.com/2015/08/29/new-fda-approved-cholesterol-drug-099/

On Thursday, the Food and Drug Administration approved Repatha, the second drug in a large class of powerful cholesterol lowering medicines. Repatha is made by Amgen, and is indicated to only be used by those with heart disease and cannot lower their cholesterol levels with statins and other therapies. This new drug, Repatha, will cost those who use it $14,100 a year.

HIGH PRICE OF REPATHA CHOLESTORAL INHIBITOR CAUSED COMMOTION AMONG DRUG COMPANIES

This high price tag has caused quite a commotion among some of the other drug companies in the industry. Express Scripts Holding Co., one of the country’s largest manager of prescription drug benefits, say that up to 10 million people are affected by extremely high levels of cholesterol. According to them, this new class of drugs to treat them has the potential to grow over the next few years to become the costliest drug therapies that the country has ever seen.

INDUSTRY ANALYSTS PREDICT THAT THE PRICE OF REPATHA WILL DROP

Industry analysts expect that with the price of Repatha will drop once rebates and other discounts are taken into account. Amgen, the company that manufactures Repatha, acknowledged the concerns about the drug’s cost. They said that they will work with the payers to provide innovative pricing programs that will make it easier to get Repatha.

This is because Amgen and Regeneron have made it clear that their intentions are to work with the people who need these drugs to manage the costs. There are currently about 11 million Americans who could benefit from this new class of drugs being approved by the Food and Drug Administration.

As of now, health insurers and other pharmacy-benefit managers will probably require both doctors and patients to exhaust other options first or get additional lab tests before getting a prescription for Repatha. Repatha is an injectable drug that is administered every two weeks. Repatha works by blocking a protein that interferes with the liver’s ability to remove LDL cholesterol from the blood. In July, the FDA approved another drug called Praulent, which is another injectable drug in the same class of medication as Repatha.

REPATHA AND PRAULENT ARE A PART OF THE PDCK9 CHOLESTORAL INHIBITOR CLASS

The new drugs in this class are called PDCK9 inhibitors have lowered the levels of LDL, the more dangerous form of cholesterol, by anywhere between 54 to 77 percent. These levels have lowered in people who are already taking other cholesterol lowering drugs. Some of the patients in the clinical trials have even seen their LDL levels drop into the single digits.

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New FDA Approved Cholesterol Drug Has $14k Price Tag

%99% of #contactlens users ignore hygiene rules, adopting behaviors that could lead them even to #blindness.% - http://clapway.com/2015/08/21/contact-lens-users-risking-blindness-101/

​In an effort to promote contact lens and eye health, Centers for Disease Control and Prevention (CDC) did a report based on a nationwide survey of 1,000 contact wearers. CDC discovered that 99 percent of them ignore hygiene rules adopting behaviors that could lead them even to blindness.

CONTACT LENS RISKS IN NUMBERS

Almost 85% of contact lens wearers say that they have showered with their lenses in while 61% have gone swimming wearing them. Health officials have always been suggesting that lenses should not come in contact with water and that even swim goggles are not a healthy solution.

Users’ cleaning habits are not better with 55% of them sometimes “topping off” their lens case with a more disinfecting solution. The official recommendation says that all contact lens users have to empty the case and then clean in before filling with fresh solution.

RELATED POST: SCIENTISTS DISCOVERED HOW OBESITY WORKS TO TREAT IT

Almost two-thirds of the surveyed sample had rinsed their contact lenses using tap water, which is a potentially risky move. As the report says, household tap water may be safe for drinking, but it is not sterile and the microorganisms contained in it can cause eye infections:

“Household tap water, although treated to be safe for drinking, is not sterile and contains microorganisms that can contaminate lens cases and contact lenses and cause eye infections,” the report says.

Over half said that they had slept overnight with their lenses in and more than 87% admitted they had fallen asleep in their contacts at some point, making napping the most common offense. While certain contact lenses are FDA approved for overnight wear, the CDC says that “sleeping in any type of lens can increase the risk of eye infections.”

Jennifer Cope, the lead author of the study, CDC medical epidemiologist said in a statement that healthy contact lens wear and care is extremely important and that many users do not have a clear idea about their proper use:

“Good vision contributes to overall well-being and independence for people of all ages, so it’s important not to cut corners on healthy contact lens wear and care. We are finding that many wearers are unclear about how to properly wear and care for contact lenses.”

THE RIGHT USE OF CONTACT LENS

The report of CDC comes with tips, to help reduce the risk of eye irritation or infections:

– Users should never sleep with their contact lenses in unless an eye care provider advises them to do so.

– All water must be kept away from contact lenses. Do not shower while wearing them and remove them before swimming or using a hot tub. Never wash or store your contact lenses in water.

– Contact lenses must be replaced as often as recommended by your eye care provider.

– Before putting their contact lenses in the case, users should clean it using fresh solution and never water.

– Store contact lens case upside down with the caps off after each use.

– The contact lens must be replaced, at leas, once every 3 months.

– Visit an eye care provider as often as recommended by your primary health care provider.

– If experiencing eye pain, blurred vision, redness or discomfort, remove the contact lenses immediately and call an eye care provider.

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Survey: Contact Lens Users Risking Blindness

%A veritable litany of research and legal disputes by the #NABCA’s make the existence of powdered #alcohol as familiar as an old (rowdy) #drinking buddy.% - http://clapway.com/2015/08/16/banning-powdered-alcohol-101/

%A veritable litany of research and legal disputes by the #NABCA’s make the existence of powdered #alcohol as familiar as an old (rowdy) #drinking buddy.%
Banning Powdered Alcohol

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

Inconsistent Standards for FDA Approval of High-Risk Medical Devices - http://clapway.com/2015/08/11/inconsistent-standards-for-fda-approval-of-high-risk-medical-devices123/

A study examining the clinical studies backing the FDA approval of high-risk medical devices revealed a large variation in their number and quality, raising valid concerns about the approval process.

WHAT ARE HIGH-RISK MEDICAL DEVICES?

A medical device is an apparatus that diagnoses, cures, lessens, treats, or prevents disease by affecting the structure and function of the human body. It differs from a drug in that it achieves its intended effect without any chemical action on the body. The FDA stratifies medical devices into different categories based on the risks they pose. The high-risk category of medical devices are defined by the FDA as those that usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of such devices include pacemakers, implanted weight-loss devices, medical imaging analyzers and cochlear implants. These devices face the toughest regulatory controls for approval from the FDA, which employs a Premarket Approval (PMA) pathway to establish the safety and effectiveness of the device.

In the study conducted, clinical studies of 28 such high-risk medical devices that received approval via the PMA pathway between 2010-2011 were tracked throughout the product lifecycle. This means studies beginning at the pre-market level required for approval, to the post-market studies that monitored the long-term outcomes of approved devices. The authors identified 286 clinical studies for the 28 devices, with 82 pre-market and 204 post-market studies, with obvious asymmetry in the number of pre-market clinical studies. The FDA used roughly one pre-market study per device to grant approval. A majority of the post-market studies too were initiated by the manufacturer (60%) and not mandated by the FDA (11.5 %). Only 6 of the 33 FDA-mandated post-market studies were reported completed. No post-market studies were uncovered for 5 of the devices, and three or fewer for 13 devices. Half the studies did not compare the device’s performance to an existing one.

What emerges from an analysis like this is the realization that there is a marked shift in the burden of proof required at the pre-market level to post-market surveillance. The risk to benefit ratio for high-risk devices are often understandably higher than others and might require an approach tailored to each specific device. While it is important to monitor the long term population based effects of high-risk medical devices, lowering the bar for their approval seems hardly the right way to go.

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Inconsistent Standards for FDA Approval of High-Risk Medical Devices 

Hacking the Hospira Pump is Real, FDA says - http://clapway.com/2015/08/01/hacking-the-hospira-pump-is-real-fda-says456/

Catching Up With Some Small talk

Medical care has always been a serious topic and an area of concern. Many court cases arise from the lack of professional courtesy, or due to operations that were unnecessary. With that being said, we cannot argue that the advancements in the medical field are astounding and ingenious at times, especially when thinking back to a century when penicillin, a heart monitor, or even the Hospira Pump didn’t exist.

The surprise announcement about hacking the hospira pump

It is very surprising to hear that the US Department of Homeland Security issued a warning to the public, revealing that Hospira’s Symbiq medication pumps, or computerized pumps used to deliver drugs, can be hacked remotely. The concerning news was discovered by a white hat (or ethical) hacker while checking the system out. According to the Food and Drug Administration, this is the first instance it has warned health care providers and caregivers to stop using a product due to a cybersecurity risk.

Inevitable Results

But what exactly is the main concern regarding the Hospira hack? The biggest worry is that the security breach gives someone the opportunity to manipulate the system. Because the device can be potentially remotely controlled, an intruder essentially has the power to change the amount of medication a patient receives. Although, newer pumps have additional protection against these potential hacks, the FDA suggests that health care providers disconnect them and update drug libraries manually. However, this method also has its drawbacks, as it is prone to human errors. The process is also much more labor intensive and may not be entirely feasible.

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Hacking the Hospira Pump is Real, FDA says

FDA Approves New Nutrition Label to Highlight Sugar - http://clapway.com/2015/07/25/fda-approves-new-nutrition-label-to-highlight-sugar678/

There have been several attempts by health professionals to prove exactly how much sugar we are consuming on a daily basis. Jamie Oliver, a famous chef, is an advocate for informing families, and often speaks out about the issues we overlook in our diets. We are being increasingly aware of what we put into our bodies, and as this movement is happening, companies are realizing that they need to be more honest in their labeling if they want consumers to still buy their products. The Food and Drug Administration (FDA) has approved a new nutrition label that will inform consumers better of how much sugar they are actually consuming.

The New Nutrition Label

This new label will highlight the amount of sugar in a product, specifically showcasing the amount of added sugars separate from the amount of total sugars. Companies are not only to be more forthcoming with this information, but they are also now required to show the amount of sugars in a percent daily value, as the rest of the label does. Susan Mayne, Director of the Center for Food Safety and Applied Nutrition, puts this into perspective for us on the FDA’s website, telling us that, “a consumer who drinks a 20-ounce sugared beverage may be surprised to know it contains about 66 grams of added sugar, which would be listed on the label as 132 percent of the Daily Value.” When you first see the 66, you don’t think it’s that much, but when it’s compared to your daily intake at 132 percent, that’s much more than you originally thought.

Ideal Consumption Percentages

Each nutrition label separates the ingredients of a product in a percentage known as your daily caloric intake. Heath officials recommend a normal person should be living off of a 2,000-calorie-a-day diet. Based on that number, 55 grams of sugar should the maximum amount of sugar a person has in a day. If you’re curious to see a visual aid on how much sugar you are consuming with your daily soda and pop tart breakfast, Sugar Stacks has you covered.

The Effects of Too Much Sugar

We all know at the extreme end of the spectrum, an over consumption of sugar can lead to diabetes and obesity, but how else is it harmful? Given that diabetes and obesity both directly affect the heart, we can conclude that sugar leads to the damage of that muscle. However, a 2013 study in the Journal of the American Heart Association showed that sugar actually affects the pumping mechanism of the heart. A 2008 study also showed us that excess sugar consumption was linked to leptin resistance. Leptin is a natural hormone that is released when we are full to let us know it’s time to stop eating, but when a person suffers from leptin resistance, their body simply does not produce this chemical and therefore has no signal to let them know they are full.

There are also natural sugars that occur in your fruits and vegetables, and people don’t necessarily take those into account either. Sugar can be okay in moderation, but it’s hard to monitor if we don’t know exactly how much sugar we are consuming from these products. This new nutrition label will help consumers to better understand just how much sugar they are putting into their body when they drink that soda, or eat that candy bar or bag of chips.

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FDA Approves New Nutrition Label to Highlight Sugar

FDA Approves New Skin Cancer Drug - http://clapway.com/2015/07/25/fda-approves-new-skin-cancer-drug567/

Some Basic Info about skin cancer

It seems that every day there are some advancements being made in medicine, and more and more of them seem to be related to treating or curing cancer.

Today, more specifically, skin cancer and the drug that was approved today by the FDA have been making headlines. Currently, the Skin Cancer Foundation said that melanoma kills nearly 10,000 people every year and almost fifteen times that much are diagnosed every year as well.

Skin cancer is not incurable, but if caught late it can spread throughout the body. Then, the disease may reach a place where it becomes inoperable.

The skin cancer drug’s fda announcement

The press release was made available yesterday afternoon by Novartis, mostly known for their new drug for heart disease recently approved by the FDA. The new skin cancer drug is called Odomzo, and it is now available for public consumption.
Novartis is a healthcare company based in Switzerland that focuses part of its efforts on pharmaceuticals. The new skin cancer drug is the newest pharmaceutical released by their company.

the drug comes with a small catch, though

The new skin cancer drug is, according to the FDA a sonidegib, which will help treat patients with melanoma that have come back after treatment and those not approved for surgery or therapy. The thing is that the drug will be used for the basal cell carcinoma in the advance part of the illness.

But the benefit is that when taken daily, the new skin cancer drug should help stop the spreading of the disease quite a bit for patients. Trials showed that the small group of testers had tumors that grew smaller and smaller when taking the new skin cancer drug, and some even went away completely.

Keep in mind, some of the side effects are not great – you will still lose hair and such, but one major concern is that there may be some muscle tissue problems that form as a result of the new skin cancer drug. So you should decide for yourself if you want to chance taking the new drug with the side effects.

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FDA Approves New Skin Cancer Drug

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

Cost of Cancer Drugs Adversely Affecting Cancer Patients - http://clapway.com/2015/07/24/cost-of-cancer-drugs-adversely-affecting-cancer-patients654/

The Journal of Economic Perspectives published a study that found the costs associated with cancer drugs have increased by $8,500 a year over the last 15 years.

Americans have a 1 in 3 chance of developing cancer within their lifetimes

A study produced by the Duke Clinical Research Institute attempted to understand the impact of health care related expenses on the treatment and well-being of insured cancer patients who requested copayment assistance.

They found that among 254 participants 42% suffered from significant financial burdens that required them to cut back on spending in categories including leisure, food, and clothing. 46% of those surveyed used savings to cover some of the out-of-pocket expenses. In an attempt to minimize the costs associated with drugs used during cancer treatment 20% took less than the amount they were prescribed.

The high price of cancer drugs creates different outcomes based on economic status.

Recommendations from Experts on Pharmaceutical Reform

Dr. Ayalew Tefferi, a hematologist at Mayo Clinic says, “High cancer-drug prices are affecting the care of patients with cancer and our health care system.”

Tefferi and 117 of his colleagues agreed on seven recommendations to address the unfair costs associated with cancer drugs. The Mayo Clinic Proceedings published these recommendations.

One of those recommendations is to allow cancer drugs to be imported across the border for personal use. Prices in Canada are about half the prices in the U.S.

Additional recommendations include allowing Medicare to negotiate drug prices, passing legislation to inhibit drug companies from delaying access to generic drugs, and creating a post-U.S. FDA drug approval review mechanism to offer fair pricing for new treatments based on value to patients. A comprehensive list of all the recommendations may be found here.

Calling for Action

Tefferi and his colleagues are in support of a petitionon change.org that calls on the President, the Secretary of Health and Human Services (HHS), and Members of the United States Congress to implement their suggestions. The petition accurately states that exorbitant prices of cancer drugs are decreasing the life span of patients who cannot afford treatment.

The petition has a goal of 15,000 signatures and has, as of now, collected just under 14,000 signatures.

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Cost of Cancer Drugs Adversely Affecting Cancer Patients

No Calorie Info on Menus, Yet - http://clapway.com/2015/07/11/no-calorie-info-on-menus-yet-235/

Not knowing what prepared food contains is an issue that can affect people’s health. This is the reason why all prepared food should, ideally, be at least accompanied by calorie info. People are entitled to know what they eat in order to make proper choices.

According to the Food and Drug administration, all restaurants and other establishments that sell prepared food and have more than 20 locations are required to make the calories of the food they offer, public.

This mean that people will see exactly how many calories all products have, since all the information will be posted on the menus or other displays.

WHAT WILL PEOPLE SEE ON THE MENUS?

This law is not only for restaurants, but also for all the stores that sell prepared food, as well as bakeries, and even coffee shops. Furthermore, when going in amusement parks, people will have the chance to choose meals, according to the number of calories they have.

In addition, to making calorie info in each meal public, restaurants must offer other information, in the customers request it. Therefore, whoever is interested in information like sodium, sugar or fat, is entitled to receive it.

WHEN WILL CALORIE info BE ON THE MENU?

But, unfortunately, people must wait a while until restaurants will have the menus updated, with all the calorie info added, as the Food and Drug Administration recently announced.

So, until December 1st, 2016, none of the above will be available. People have to wait more than one year until restaurants comply with federal menu labeling rules, even if the original deadline was much earlier.

The reason why FDA extended the deadline is that a large number of retailers ask for more time, in order to manage installing new menus, as well as creating software and other technology, that will aid the process of displaying calories and other information about the food served.

Food industry welcomes delays

While many health militants consider this delay a win for the restaurant lobbyists, the food industry welcomed it, not only because of the lack of time, but also because of the costs this new rule seems to involve.

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No Calorie Info on Menus, Yet

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

FDA Warning: Pain Relievers May Not Be Your Friend - http://clapway.com/2015/07/10/pain-relievers-may-not-be-your-friend654/

FDA warns public about pain relievers

Everyone loves pain relievers for one thing, their ability to take away all the sores and pain from whatever ails at the moment. However, the FDA is strengthening its warning about pain relievers and how they increase the risk for heart attack and stroke from the ingredient known as NSAID, or Non-Steroidal Anti-Inflammatory Drug.

NSAID, for those who don’t know, is one of the more common pain relief meds one can get and is used to treat a variety of pain symptoms. But also it is used to lower swelling and fever.

The Risks of Pain Relievers

Although there is already a written warning on all boxes of pain meds warning of the risk of heart attacks and strokes, the FDA is increasing the seriousness of the warning. Researchers are not sure exactly what is causing the attacks to occur, but the unfortunate side effects can occur in the first few weeks after taking a pain reliever.

It is important to remember that if you are continuing to use NSAIDs, then the risk of having those attacks increases. Also, it is noted that although aspirin contains NSAID, the risk warning does not apply to the medication.

Further warnings

Naturally in prescriptions there may be times when your doctor or physician prescribes more than one medication for you for pain management or other reasons. In these cases, considering the topic of discussion, you should avoid taking multiple meds that contain NSAID.

The reason being that other prescription medications contain NSAID. So if you were to take more of the same ingredient, naturally your risk of attack goes up exponentially.

Right now, the FDA is calling for manufacturers to update the information that is printed on medication both prescription and over the counter. The updated information with medication containing NSAID will be more specific in its risks of heart attacks and strokes. The FDA is also requesting that the manufacturers update their facts page about the pain reliever ingredient, NSAID.

Unfortunately, if you have already suffered a heart attack or stroke and you take pain relievers with NSAID, then the risk for you goes up as well. This means millions of Americans that suffer from heart disease and heart attacks are at an increased risk of having another attack in taking the medication. Even dying in their vulnerable state, which is why the FDA is issuing out the increased warnings about the NSAID ingredient to the public for their awareness.

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FDA Warning: Pain Relievers May Not Be Your Friend

New Heart Failure Pill Entresto Approved by FDA - http://clapway.com/2015/07/08/new-heart-failure-pill-entresto-approved-by-fda789/

Helping to Prevent Heart Failure

Many diseases or health complications are tough to deal with, but a healthy heart is essential to any human being’s long-term survival. That is why yesterday, the FDA approved a new medicinal pill called Entresto from Norvartis for treating heart failure. The announcement of the approval was released by both the FDA and Novartis yesterday, showing both parties’ eagerness in helping to reduce the threat of heart failure and the often ensuing death from heart complications.

A brief overview of heart failure

For those unfamiliar with heart failure and its history, heart complications happen when the heart is not pumping blood as well as it should, and there are not enough nutrients and oxygen reaching parts of your body. According to the CDC, every year in the U.S. alone, citizens die of heart disease complications often- every 1 in 4 deaths. In the news release by the FDA, the number of people stated to be affected by heart failure is a whopping 5.1 million people in the U.S. There is no cure for this complication, but you can live with it. This is where our drug, Entresto, comes into play.

What is Entresto?

Entresto is said to be a neprilysin inhibitor and angiotensin II receptor blocker that will help to reduce of the risk of dying from heart failure, and also allow for fewer trips to the hospital. The pills are to be taken twice a day along with other heart failure meds you may be prescribed, but it is advised against taking the drug when you have had Angiodema. It is also advised not to take Entresto if you start suffering from this allergic reaction while taking the drug, because breathing becomes difficult as a result.

But this is not the only side effect of taking Entresto; there are other complications that arise when taking the pill. Some of the side effects include hypertension, kidney problems, etc.

Good Intentions from Entresto

The reduction rate of death and hospitalization when using the drug is around twenty percent. With the approval of the new medication, the 5.1 million afflicted with heart failure, as reported by the FDA, now have hope of living better as a result. Now that it is approved in the U.S., the drug is now being reviewed in other countries for approval. Then, subsequent distribution is expected to follow after approval.

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New Heart Failure Pill Entresto Approved by FDA

New Drug for Cystic Fibrosis Approved by FDA - http://clapway.com/2015/07/03/new-drug-for-cystic-fibrosis-approved-by-fda765/

New Drug for Cystic Fibrosis approved by FDA

Yesterday, the FDA announced its approval of the new drug to treat those who have the F509del mutation of Cystic Fibrosis. The announcement can be found on their website, in which the post about the new drug for Cystic Fibrosis was put up for immediate release.

What is the new drug for Cystic Fibrosis?

The new drug is called Orkambi that is a combination therapy to treat CF, featuring the chemicals ivacaftor and lumcaftor. The new drug for Cystic Fibrosis is supposed to help correct the mutated genes in the afflicted whereas before efforts were concentrated on treating the symptoms of CF.

Drug cut through some tedious wait time.

In addition to being approved by the FDA, the new drug was given the drug designation of “orphan drug” for its treatment of CF, which brings many benefits to the developers of the drug. Among those benefits are financial incentives, and other promotional deals to produce the drug. The drug has cut through some longer trial testing in the priority review of six months or so instead of the usual ten month trail because the new drug for Cystic Fibrosis is supposed to be a huge game changer.

The clinical trials had positive results which helped in the drug getting its approval by the FDA. In fact, in the study those who took two of the new drug for Cystic Fibrosis every twelve hours showed having better lung function than those who were taking the placebo.

However, the new drug for Cystic Fibrosis is not without its drawbacks as well. The common side effects of the drug in the news release are shortness of breath, upper respiratory tract infection, nausea, diarrhea, and rash that can pop up. Some women who took the drug even experienced increased menstrual bleeding and a few other things.

But there is also the fact that the drug is targeted only to a specific genetic mutation and not the disease as a whole, although some help is better than no help at all in aiding those afflicted with CF.

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New Drug for Cystic Fibrosis Approved by FDA