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Despite Warnings, FDA Approves Potent New Opioid Painkiller


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The Food and Drug Administration has approved a potent new opioid painkiller, despite warnings from physician critics who say the drug will contribute to the addiction epidemic.

Dsuvia, a 3-millimeter-wide tablet of sufentanil made by AcelRx, came before an FDA advisory committee on Oct. 12. Such committees weigh in on the safety and efficacy of proposed products, and the FDA generally follows committee guidance in its decisions about drugs. The FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 to recommend approval for the medication, and the agency approved the drug Friday.

"There are very tight restrictions being placed on the distribution and use of this product," said FDA Commissioner Scott Gottlieb in a written statement Friday regarding his agency's approval of Dsuvia. "We've learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We've applied those hard lessons as part of the steps we're taking to address safety concerns for Dsuvia.

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Warning from doctors.....thats rich.    Doctors are the number one problem because of over prescribing drugs.   Some patients do really need them. 

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I had brain surgery less than two weeks ago, and was shocked on the lack of pills I was offered. I don't take pain pills, but surgeries in the past they often prescribed 100 pills without even asking! I still prefer Tylenol and Ibuprofen vs opiods! 

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44 minutes ago, Dieselgeek said:

I had brain surgery less than two weeks ago, and was shocked on the lack of pills I was offered. I don't take pain pills, but surgeries in the past they often prescribed 100 pills without even asking! I still prefer Tylenol and Ibuprofen vs opiods! 

I wish this was MC posting this.

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1 hour ago, Highmark said:

Warning from doctors.....thats rich.    Doctors are the number one problem because of over prescribing drugs.   Some patients do really need them. 

A buddys wife works for Mckessen shes been in the top few sales positions for about 7 years now. She prides herself with pushing more than double the normal amount of Oxys on these small practices for her success.     Her bosses PUSH them to do this as it obviously helps the bottom line.  Sad thing is both her kids are all fubar from just what she sells and shes still ramming them down the throats of these practices..  talk about Fucked up.   

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Just now, old indy said:

A buddys wife works for Mckessen shes been in the top few sales positions for about 7 years now. She prides herself with pushing more than double the normal amount of Oxys on these small practices for her success.     Her bosses PUSH them to do this as it obviously helps the bottom line.  Sad thing is both her kids are all fubar from just what she sells and shes still ramming them down the throats of these practices..  talk about Fucked up.   

I do believe that would qualify as the definition of a whore.

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1 hour ago, Dieselgeek said:

I had brain surgery less than two weeks ago, and was shocked on the lack of pills I was offered. I don't take pain pills, but surgeries in the past they often prescribed 100 pills without even asking! I still prefer Tylenol and Ibuprofen vs opiods! 

Yeah same. I had a severe case of shingles last winter. Crazy painful. They told me to just take Tylenol lol

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6 minutes ago, Rod Johnson said:

Yeah same. I had a severe case of shingles last winter. Crazy painful. They told me to just take Tylenol lol

They really have throttled back on Dr. Prescribed meds. Earlier this year I had a procedure that warranted after care pills, I had to sign half a dozen waivers just to get a script for a few. (Haven't had a reason to take them in years! So no history of meds for a long time) shortly thereafter I have been getting spam phone calls from local number robots asking about my "chronic pain" and how to locate pain centers near me! (Never happened prior) Coincidence? I think not. So much for Dr, patient, confidentiality... 

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8 hours ago, old indy said:

A buddys wife works for Mckessen shes been in the top few sales positions for about 7 years now. She prides herself with pushing more than double the normal amount of Oxys on these small practices for her success.     Her bosses PUSH them to do this as it obviously helps the bottom line.  Sad thing is both her kids are all fubar from just what she sells and shes still ramming them down the throats of these practices..  talk about Fucked up.   

What a fucking greedy cunt and karma is a bitch.

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On 11/3/2018 at 6:03 PM, steve from amherst said:

The Food and Drug Administration has approved a potent new opioid painkiller, despite warnings from physician critics who say the drug will contribute to the addiction epidemic.

Dsuvia, a 3-millimeter-wide tablet of sufentanil made by AcelRx, came before an FDA advisory committee on Oct. 12. Such committees weigh in on the safety and efficacy of proposed products, and the FDA generally follows committee guidance in its decisions about drugs. The FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 to recommend approval for the medication, and the agency approved the drug Friday.

"There are very tight restrictions being placed on the distribution and use of this product," said FDA Commissioner Scott Gottlieb in a written statement Friday regarding his agency's approval of Dsuvia. "We've learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We've applied those hard lessons as part of the steps we're taking to address safety concerns for Dsuvia.

This drug is for in patient use only. Settle down.

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On 11/4/2018 at 8:05 AM, old indy said:

A buddys wife works for Mckessen shes been in the top few sales positions for about 7 years now. She prides herself with pushing more than double the normal amount of Oxys on these small practices for her success.     Her bosses PUSH them to do this as it obviously helps the bottom line.  Sad thing is both her kids are all fubar from just what she sells and shes still ramming them down the throats of these practices..  talk about Fucked up.   

They can push them all they want, the doctors don't have to prescribe them.   Not saying the drug rep's aren't responsible but doubt they take an oath like physicians.  

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16 minutes ago, Highmark said:

They can push them all they want, the doctors don't have to prescribe them.   Not saying the drug rep's aren't responsible but doubt they take an oath like physicians.  

Yeah right, that's like dangling a piece of meat in front of a dog's nose and expecting him not to eat it. Greed!!!! Follow the money.

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24 minutes ago, snoughnut said:

Yeah right, that's like dangling a piece of meat in front of a dog's nose and expecting him not to eat it. Greed!!!! Follow the money.

Not saying its not greed or money but shouldn't we have higher expectations from our physicians especially now given the epidemic we are facing?  

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