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PostPosted: Mon Jul 04, 2016 10:32 am 
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FDA now wants their own FDA-approved gateway drugs to require warning labels stating the obvious: Opiod painkillers 'may' cause addiction, death
by: J. D. Heyes
FDA drugs, opioid warnings, addiction epidemic

In case you were wondering, dangerous opioid drugs cause addiction and can kill you. But the Food and Drug Administration (FDA) is just now catching on to that.


"It is just staggering and heartbreaking to see the toll that abuse is taking," said Dr. Tom Frieden, director of the U.S. Centers for Disease Control and Prevention (CDC), during a telephone briefing for reporters. "The epidemic is affecting all of society."

So what's the solution? Apparently to issue "warnings." Well, really, stronger warnings. Oh.

In recent days, federal heath officials strengthened drug label warnings for FDA-approved addictive painkillers, while calling for more government-funded addiction treatment, as the opioid overdose epidemic is "blurring" into a heroin epidemic as well (but by all means, let's legalize more drugs

To draw more attention to the epidemic, as if it needed more, President Obama will address it at an upcoming drug abuse summit in Atlanta, adding voice to bipartisan calls from the National Governors Association to "call attention to the U.S. opioid crisis," Buzzfeed News reported.

No, they're REALLY bad for you

Some 40 Americans die every day from an opioid painkiller overdose, but then there are some 200 million prescriptions written for the drugs in the U.S. alone every year. Use of opioids has quadrupled since 1999, in fact. And, Buzzfeed News reports, between 1999 and 2014 about 165,000 people died from overdoses, many times as a result of taking an opioid with tranquilizers like Valium and Xanax.

The FDA's solution is to issue new, more specific warnings, as if to say, "No, really – opioids are bad for you."

The new labeling will be required for immediate-release versions of oxycodone, morphine, not allowed and related drugs, and will warn of the dangers of "abuse, addiction, overdose and death," from their use.

"We know that there is persistent abuse, addiction, overdose mortality and risk," of newborn withdrawal syndrome associated with the painkillers, Douglas Throckmorton, the FDA Deputy Center Director for Regulatory Programs, said in a statement on the new labels.

The director of National Drug Control Policy at the White House, Michael Botticelli, has called on Congress to back an administration request for $1.1 billion to support more treatment programs, disposal of unneeded painkillers, and supplying more communities with naloxone, a drug that reverses overdoses.

The CDC recently unveiled opioid painkiller guidelines for primary care providers, which state that they should only be prescribed, "when benefits for pain and function are expected to outweigh risks."

'We have a long way to go'

Gary Mendell, founder and CEO of Shatterproof, a non-profit organization supporting addiction treatment, applauded the new guidelines, calling them "an important first step to ending this terrible epidemic."

Not everyone agrees, as you might imagine. One such critic is Bob Twillman of the American Academy of Pain Management (yes, there really is such a group, who has warned that the new guidelines may discourage some doctors from enriching Big Pharma at the expense of their patients' health (okay, he didn't really say that, but that's the gist). He says that the new guidelines will likely lead to fewer prescriptions.

"Simply put, the one statement that best summarizes the goal of the CDC guideline is, 'Take all steps possible to minimize exposure to opioids when treating chronic pain,'" Twillman wrote. "While CDC undoubtedly is well-intentioned, achieving this goal must be done in a way that does not harm the vast majority of people using opioids to manage their chronic pain–who have a positive risk/benefit ratio and who do not misuse or abuse their vital medications."

For his part, Botticelli says that an increase in heroin overdoses is part of the reason the FDA and other federal officials are moving to curb the use of opioid painkillers, which often occurs among those addicted to prescribed drugs.

"We have a long way to go," he said, adding that overdose death rates have been at record levels since 2013.



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PostPosted: Wed Sep 28, 2016 4:40 pm 

Joined: Sat Feb 21, 2015 10:55 am
Posts: 83
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