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Generic OxyContin Banned by FDA Until Reformulated to Help Abuse

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Generic Oxycontin

The Food and Drug Administration (FDA) announced Tuesday, April 16, 2013, that it will not approve any generic version of OxyContin until it gets made with the new formula.

The generic Oxycontin is still being made with the original formula, which the FDA believes makes the drug easier to abuse.

“The FDA will not approve any generics to the original formulation of OxyContin,” said FDA spokeswoman Morgan Liscinsky, adding that there are no FDA-approved generics of OxyContin on the market right now.

The new formula of OxyContin was developed by Purdue Pharma LP after years of research to create a tamper-resistant version of the painkiller.

“Purdue is gratified that the FDA has determined that the original OxyContin extended release tablets were withdrawn from sale for reasons of safety or effectiveness,” the company said in a statement.

“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin.”

The new Oxycontin tablet is harder to crush, break, or dissolve. It also forms a viscous hydrogel and cannot be easily prepared for injection. The FDA has determined that the physical and chemical properties of the reformulated painkiller is expected to make it difficult to inject and to reduce abuse via snorting.

Oxycodone hydrochloride is the chemical name of the drug, which is sold under the brandname OxyContin. Fox News reported that, without competition from generics, the price of the painkiller is not likely to decrease.

Oxycontin already has a Schedule II status in controlled substances as a potentially harmful and restricted-access narcotic, based on an FDA review.

In January, a FDA advisory panel voted to move other hydrocodone-containing painkillers such as Vicodin and Percocet into the same status.  Meaning, no prescription for a controlled substance in schedule II may be refilled.

Schedule II substances are typically only given once a month. Federal law does not allow refills to be given, unless the doctor thinks it’s necessary.  If that’s the case, he/she can write a new 30-day prescription to the patient.

The FDA approved the original formula of OxyContin in 1995. While the painkiller was manufactured to release pain over about 12 hours, crushing the tablets defeated those extended-release properties and produced a fast, powerful high when snorted, injected or even sprinkled on food. OxyContin became known as “hillbilly heroin.”

With that type of abuse, the FDA says an increased “risk of serious adverse events, including overdose and death,” could happen.

OxyContin is one of the top selling prescription drugs within the United States, bringing in over $2.8 billion in sales just last year.

With prescription drugs being the leading source of drug abuse, having a new formula will help prevent the misuse and fight against prescription drug abuse.

FDA Bans Generic Oxycontin in Bid to Stop Abuse

The U.S. Food and Drug Administration late Tuesday banned generic versions of the narcotic OxyContin, a victory for Purdue Pharma, which produces a version that is resistant to abuse via injection and snorting.

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Oxycodone and Hydrocodone Prescriptions On the Rise, Addiction Epidemic
The Fight Against Prescription Drug Death Epidemic

Environmentalist. Consumer Tech Journalist. Science Explorer. And, a dreamer. I've been contributing informative news content since 2010. Follow me on all socials!

6 Comments

6 Comments

  1. Serge Oberoi

    March 31, 2019 at 12:41 pm

    Purdue Pharma must be held responsible for the deaths directly or indirectly that have resulted from the use and promotion of OxyContin. Purdue should also be held responsible to pay for the treatment of those suffering from addiction to this dangerous drug. OxyContin perhaps had done more damage than illicit drugs that are smuggled from south of the boarder. President Trump will be well advised to clampdown on so called legally “Made in the USA” drugs that are killing US citizens in hundreds of thousands and turning American youth into drug addicts. Medical doctors should be prohibited from prescribing OxyContin or similar drug to new patients.

  2. chuff425

    April 18, 2013 at 12:22 pm

    All this does is raise the price for patients who actually NEED this medication. Forcing them to pay more for the name brand meds. It won’t stop abuse, and most likely will not even slow it down. Way to go FDA…Screw the patients, everyone else is….may as well follow suit.

  3. Chronic Pain

    April 17, 2013 at 1:01 pm

    I have chronic pain. I must be addicted to pain. Maybe thats why I lay in bed crying. I get about 2 hours of sleep a night. I need meds. I have been taking for 8 years, and until the pain is gone, I will continue using pain killers. Sure I am addicted, but thats my problem and my choice to take them. I can stop anytime, but I wouldn’t be able to work or get out of bed for that matter. Life, liberty, and the pursuit of happiness mean nothing in this demoralized nation. Maybe I should start doing heroine? I have seen friends with similar conditions actually do that. Doctor cuts them off, can’t find pill on street so turns to another opiate. This is why you get drug problems. Once they turn to heroine its like theres no going back. IF you believe in freedom, stop wrapping yourself in the flag and trying to effen regulate everyones life! I should be able to go to the barber shop like you could 100 years ago, and get whatever I want. Tell me, if the doctors can’t “treat” my pain – and I have spent 10’s of thousands of dollars on treatments – still can’t get out of bed with out a pill – i can’t even move. Why do I have to go to a doctor every month just to get a effen refill? I mean, its a waste. I paid 104 dollars for 5 minutes and get a piece of paper saying I can get x amount. I should be able to go to store and get what I want. I know whats wrong my back hurts from my S1 all the way to my neck. ITS MY ENTIRE SPINE! NO PERSON ON THIS EARTH HAS THE RIGHT TO REGULATE FREEDOM!!!

  4. Mags

    April 17, 2013 at 12:45 pm

    Damage from OxyContin is done, Big Pharma companies should have to pay for the ravished addicts we have in every city across our country. The FDA under a republican administration allowed this highly addictive substance on the market. MAKE THE CORPORATION PAY !!!!

    • J Hyman

      April 17, 2013 at 12:56 pm

      The h&ll with that. It’s a useful drug for those in pain. Hold the abusers responsible. Accuracy note: Purdue isn’t exactly Big Pharma.

    • beans

      April 17, 2013 at 12:58 pm

      The political party affiliation has no impact on the FDAs decision to allow Oxy to be sold in a highly addictive and easy to abuse format. It’s just bad medicine.

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Editors' Pick

AMCA Breach: 20 Million Victims, 19 Class Actions

[bctt tweet=”AMCA previously reported that there were only 200,000 victims in the recent breach, but their partner labs said there were more than 20 million.” username=”Z6Mag”]

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AMCA previously reported that there were only 200,000 victims in the recent breach but the company, but their partner labs said there were more than 20 million.
AMCA previously reported that there were only 200,000 victims in the recent breach but the company, but their partner labs said there were more than 20 million. Photo: cbgrfx123 | Flickr | CC BY-SA 2.0

More than 20 million and not 200,000 have fallen victim to a massive data breach that has seen medical clients using the services of healthcare billing company, American Medical Collection Agency (AMCA), to pay for their laboratory tests in different blood testing labs across the U.S. were confirmed by the SEC filings of affected medical institutions amidst the earlier claims of AMCA that there were fewer victims.

The data breach was a result of a cyber attack that aims to phish for financial information from the website of the AMCA. The exposed data belongs to Americans who paid laboratory services at several clinical and blood testing labs and institutions and used the AMCA billing portal.

What happened in the AMCA breach?

Data that were stolen from the victims include their names, phone numbers, dates of birth, home addresses, social security numbers, credit card numbers, and other bank details. The said information was auctioned off by the hacker in several financial hacking forums.

According to DataBreaches.net, the organization who first reported about the incident, AMCA officials, following the notification of the breach confirmed that their system has been compromised and has remained undetected for more than eight months. AMCA corroborated that the breach took place between August 1, 2018, and March 30, 2019.

Notifications have been sent by several of AMCA’s corporate partners and clients to their customers following the disclosure of the security breach that has seen information from millions of Americans compromised.

Related: Hospitals Only Spend 5% Of Its Budget For Cybersecurity Amidst 82% Of Them Reporting To Have Been Attacked

The list of impacted testing laboratories includes Quest Diagnostics (11.9 million patients), LabCorp (7.7 million patients), BioReference Laboratories (Opko Health subsidiary, 422,600 patients), Carecentrix (500,000 patients), and Sunrise Laboratories (undisclosed number of patients).

However, neither the AMCA nor its five clients have yet to notify ALL impacted citizens by the breach making them vulnerable to a lot of cyber crimes and their financial data could be used by anyone who gets hold of the information against the persons of those who still don’t know that their financial information is floating around the internet.

The companies involved in the breach are facing several lawsuits

Appropriately, the lawsuit came into the direction of AMCA, Quest, and LabCorp regarding the incident. More than 11 class-suite actions have been filed against the three companies for their inability to protect consumer data. The 11 lawsuits were recorded at The United States Judicial Panel on Multidistrict Litigation (JPML) on June 3. Since then, eight more lawsuits were filed against the companies in federal courts from New Jersey, New York, and California.

According to litigation experts, “If many cases are filed in federal court, any of the lawyers on any of those cases can file a motion with the JPML [..] to centralize the various federal cases that have been filed by sending all of them to a single judge for coordinated pre-trial proceedings.”

“Healthcare companies are especially susceptible to data breaches not only because they aggregate a tremendous amount of important and sensitive data, but also because they tend to be less focused on cybersecurity protection than other industries,” said John Yanchunis of Morgan and Morgan, one of the firms who filed lawsuits against Quest Diagnostics.

“These companies, like Quest Diagnostics, know they are at an increased risk and yet have not taken the proper steps to protect their patients’ data. We will fight for justice on behalf of those impacted by this breach,” added Yanchunis.

Lawmakers are demanding an explanation

The U.S. government, led by attorneys general from Connecticut and Illinois has also opened an investigation on the matter. Furthermore, lawmakers and other politicians have sent letters to the responding companies to ask for an explanation of why an eight-month data breach remained undetected and to demand accountability from them.

In Washington, US Sen. Mark Warner (D-VA) also sent a letter to Quest Laboratories demanding the company explain its vetting process for selecting AMCA as a billing vendor, and what requirements a third-party vendor has to pass. Democratic New Jersey Sens. Cory Booker and Bob Menendez also sent letters to AMCA, Quest, and LabCorp, seeking official answers on how a breach of this severity went undetected for eight months.

“The months-long leak leaves sensitive personal and financial information vulnerable in the hands of criminal enterprises. Moreover, such breaches force victims to contend with identity theft that may lead to irreparable harm to their credit reports and financial future,” said the letter sent by the NJ senators.

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Arts & Entertainment

‘The Hunger Games’ Is Launching A Prequel And A Possible Movie

[bctt tweet=”Suzanne Collins is releasing a prequel to The Hunger Games storyline and Lionsgate is already looking forward in turning it into a blockbuster movie” username=”Z6Mag”]

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Source: Scholastic

Almost fours years after the last The Hunger Games movie (The Hunger Games: Mockingjay Part II) and almost nine years after the first book from the trilogy was released, Suzanne Collins is returning with the famed trilogy — but this time in a form of a prequel.

Scholastic, the publishing company that distributed Collins’ The Hunger Games trilogy, announced today that it is publishing a prequel novel to the series, currently untitled, which will hit shelves on May 19, 2020.

“Suzanne Collins is a master at combining brilliant storytelling, superb world-building, breathtaking suspense, and social commentary,” Scholastic Trade Publishing President Ellie Berger said in a statement. “We are absolutely thrilled — as both readers and publishers — to introduce the devoted fans of the series and a new audience to an entirely new perspective on this modern classic.”

Collins’ original Hunger Games trilogy—The Hunger GamesCatching Fire, and Mockingjay—altogether, sold more than 100 million copies and has been translated into more than 50 languages. Moreover, The Hunger Games books appeared on the New York Times bestseller list for more than 260 consecutive weeks (more than five straight years).

After writing the last installment in 2010, Collins teased in 2013 that she was working on a new series, but did not say whether it was related to The Hunger Games.

This time, the novel will be set in the world of Panem, 64 years before the events of the original Hunger Games trilogy—the morning where Katniss Everdeen volunteered as a tribute on the 74th Hunger Games. Presumably, Katniss Everdeen played by Jeniffer Lawrence will not be involved in the upcoming novel.

Based on the previous novels in the series, 74 years before the main novels, the 13 Districts of Panem already tried to initiate a rebellion against the Capital. In the aftermath of the failed attempt, 12 Districts remained to leave District 13 to rubbles. The Hunger Games was a result and served as a reminder that all the other Districts should obediently comply with the Capital’s rule.

The novel will take place 10 years after the first rebellion and will tell the story of Panem during the “Dark Days following a failed rebellion in Panem “With this book, I wanted to explore the state of nature, who we are, and what we perceive is required for our survival,” Collins told the Associated Press in the announcement. “The reconstruction period 10 years after the war, commonly referred to as the Dark Days — as the country of Panem struggles back to its feet — provides fertile ground for characters to grapple with these questions and thereby define their views of humanity.”

On other news, the Lionsgate film studio, who adapted The Hunger Games trilogy into movies, is already looking forward to the next addition to Collins’ franchise given that it received praise and public attention for producing them.

“As the proud home of the Hunger Games movies, we can hardly wait for Suzanne’s next book to be published,” said Joe Drake, chairman of the Lionsgate Motion Picture Group, in a recent statement to the Associated Press. “We’ve been communicating with her during the writing process and we look forward to continuing to work closely with her on the movie.”S

Lionsgate turned Collins’ Hunger Games novels into a series of four films, dividing the last novel, Hunger Games: Mockingjay, into a two-part finale. Over the course of the four movies, it earned almost $3 billion dollars an the worldwide box office with the last movie earning $653.4 million.

Collins helped with the movies as an executive producer and a co-screenwriter on the first 2012 movie but distanced herself after she finalized Mockingjay in 2010.

Lionsgate is also known to have produced Twilight, which is one of their platinum franchises along with Collins’ trilogy. The studio earlier licensed The Hunger Games to theme parks and live concert tours being built around the movie franchise.

Additionally, it starred Jenniffer Lawrence who played the main character as Katniss Everdeen in all of the four movies, which helped catapult her acting career in 2012.

Scholastic acquired world English rights to the prequel novel and it will publish in print, digital and audio formats in the US, Canada, the UK and Ireland, Australia, and New Zealand next year. The deal was negotiated by Rosemary Stimola of the Stimola Literary Studio for Suzanne Collins and David Levithan, VP, Publisher, and Editorial Director, for Scholastic.

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Editors' Pick

Global Ice Melting At Rates Faster Than Expected

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Photo by Sergey Kuznetsov on Unsplash

The global ice, or the size and number of glaciers located across cold spots around the world, is a clear indicator of the effects of global warming. With human’s excessive and consistent use of o-zone depleting resources such as fossil fuels — the rate of global ice is melting will only keep accelerating.

The National Snow and Ice Data Center reported that based on data they have gathered since the1900s, glaciers around the globe are shrinking and melting at an alarming rate.

Arctic sea ice has been in constant general low over the years following the increasing trend of greenhouse gas. Additionally, as the frozen ground across the Arctic melts, it releases a massive amount of methane, a potent greenhouse gas. Scientists say that this effect could make global ice melt accelerate even faster.

A separate study found that parts of the Canadian Arctic are experiencing a rate of permafrost thaw six times the long-term average.

Meanwhile, melted ice is especially notable both in and around Greenland — home to the second largest ice sheet on the planet.

“Communities in #Greenland rely on the sea ice for transport, hunting, and fishing. Extreme events, here flooding of the ice by abrupt onset of surface melt call for increased predictive capacity in the Arctic,” Steffen Olsen, a climate researcher at the Danish Meteorological Institute said in a tweet.

Olsen was referring to Greenland losing 2 billion metric tons of ice. “The high melt is unusual so early in the season but not unprecedented,” Greenland Ice said in a tweet.

Experts are calling the lost ice “not normal” considering that it equates to almost half of Greenland. Roughly 45 percent of the ice sheet surface has been melting. Usually, less than 10 percent of the ice sheet surface is melting at this time of year. According to data from the National Snow and Ice Data Center, Wednesday set a daily record for the widest melt area on that date, with 275,000 square miles.

“I’m losing the ability to communicate the magnitude [of change],” Jeremy Mathis, a longtime Arctic researcher and a current board director at the National Academies of Sciences told Mashable. “I’m running out of adjectives to describe the scope of change we’re seeing.”

On other parts of the globe, a city in western Alaska is experiencing drastic changes to its land formations as the state’s ice and permafrost are starting to thaw away.

“Springtime in Alaska isn’t what it used to be. This is the 3rd time past 21 years we can say” warmest spring of record.” 1998 was the warmest to date, exceeded in 2016 and now 2016 exceeded in 2019. Trend +4.0F (+2.2C) since the 1970s.” Rick Thoman said in a tweet.

The continued ice and permafrost melting in Iceland are causing significant damages in terms of requiring towns and villages like Newtok in western Alaska to relocate to avoid dangers.

“It’s a real challenge because in the US there isn’t the precedence to deal with this and there isn’t the political framework to deal with it either,” said Susan Natali, a scientist and Arctic expert at the Woods Hole Research Center in Massachusetts. “The numbers needing relocation will grow, the costs are going up and people’s lives and cultural practices will be impacted.

“Every year there’s a new temperature record, it’s getting worse and worse and you feel like a broken record saying it. This should be the number one urgent conversation happening right now because it’s not just going to be Alaska, it’s going to be other communities all over the US,” Natali added.

The problem does not only persist in Greenland, the Arctic or Alaska. Global ice is melting all across the globe. “The famed snows of Kilimanjaro have melted more than 80 percent since 1912. Glaciers in the Garhwal Himalaya in India are retreating so fast that researchers believe that most central and eastern Himalayan glaciers could virtually disappear by 2035 […] From the Arctic to Peru, from Switzerland to the equatorial glaciers of Man Jaya in Indonesia, massive ice fields, monstrous glaciers, and sea ice are disappearing, fast,” the National Geographic reported.

This week, the Pope has talked to oil executives in the Vatican to find solutions in the growing problem of global warming. He called for a “radical energy transition” from conventional fossil fuels and develop greener energy alternatives.

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