• Combat Addiction To Painkillers: FDA Approves Addictive Painkiller

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    Prescription pain medicine addiction grabs headlines when it sends celebrities spinning out of control. It also plagues many people out of the spotlight who grapple with painkiller addiction behind closed doors.

    But although widespread, addiction to prescription painkillers is also widely misunderstood — and those misunderstandings can be dangerous and frightening for patients dealing with pain.

    November 25 2014 – Last Thursday, the Food and Drug Administration approved a new painkiller that claims to combat the nation’s widespread, lethal addiction to painkillers.In 2010, anywhere from half to three-quarters of drug overdoses in America were from painkillers. 12 million people abused them for non-medical reasons and addiction is also surging among teenagers. According to the CDC, prescription opioid abuse sends 420,000 people to the emergency room every year and death from opioid abuse is greater than heroin and cocaine combined. 46 Americans die every day from painkillers—more than one individual every hour.

    But that was not enough. Faced with outrage over the growing epidemic, the FDA approved Purdue Pharmaceuticals Hysingla last week. Hysingla contains a potent dose of highly addictive hydrocodone–120 mg–but lacks acetaminophen, a mild painkiller found in products like Tylenol (that is not without its own side effects). Hysingla is …

    This is coming on to a market that is currently flooded with products that do not have abuse-deterrent options.

    Still, the FDA advises the 120 mg dose of hydrocodone “should not be prescribed to people who have not previously taken an opioid medication,” and that any dose over 80 mg for a new patient is unsuitable (exposing how powerful the new drug actually is).

    Nevertheless, the new pill’s manufacturer, Purdue Pharmaceuticals claims Hysingla is an “abuse-deterrent” because it is difficult to crush or dissolve in water. Apparently forgetting that drug addicts will consume their drug of choice in any way possible, Dr. David Haddox, the company’s chief of health policy, said the pill is a

    “gelatinous, gooey mass that doesn’t pull into a syringe easily.”

    The FDA parroted these claims:

    For patients who benefit from hydrocodone alone for the treatment of pain severe enough to need an opioid, this offers the advantage of once-a-day dosing in a formulation that we expect will reduce abuse and misuse.

    But addiction experts disagree. The New York Times reported:

    Dr. Andrew Kolodny, the chief medical officer at Phoenix House, a group of nonprofit addiction-treatment centers, said he was disturbed by the drug’s approval and disappointed that the F.D.A. did not seek input from an advisory committee of experts.

    Dr. Kolodny said that addicts knew how to break down abuse-deterrent products for oral use, and that the 120-milligram tablets were particularly dangerous because they ‘pack an enormous amount of hydrocodone.’

    Last year, the FDA approved Targiniq, another Purdue “abuse deterrent” that like Hysingla, experts warned could still cause dependency. It, like Hysingla, was approved without the consult of an expert review board.

    It is no secret that the FDA could have long ago approved other substances for the treatment of serious pain. Pain relief is one of the most commonly accepted uses of marijuana, but because the plant does not enjoy a powerful corporate lobby, it has long been barred from legal use (even though the government holds a patent on its medicinal qualities).

    At this point, few Americans are fooled by the FDA’s false claims that it protects the health of the population. Simply disregarding or failing to seek the opinions of experts they hire would be enough to prove this point. That they disregard these experts to routinely side with corporations on matters that are literally life or death makes their true motives even more obvious.

    However, with the growing awareness of these addictive “medicines,” there is hope that individuals will look to alternative forms of medicine to treat their ailments, avoiding “FDA-approved” solutions whenever possible.

    Still, it was just a day after the FDA announced its support for this rescheduling that the agency approved Zohydro. And a similarly controversial approval took place earlier this year around another high-dose extended-release narcotic painkiller, called Targiniq. Although this drug comes with naloxone, a new “anti-opioid” compound, the mitigating effects of naloxone kick in only if the drug is injected or snorted – not if it is taken orally.Critics of the approval acknowledge that this approach will help keep Targiniq out of the hands of recreational users. Yet because the drug, again, comes without a hard shell, there will be nothing to stop a user from chewing up a pill and receiving a full dose all at once, either on purpose or by accident.

    Further, “FDA approved Targiniq without convening a scientific advisory committee meeting,” the Fed Up! letter notes. “The decision by FDA to bypass the advisory committee violated its own policy.”

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