Fast forward two years and the FDA is back on the same issue, but this time they are issuing the strongest recommendations to date. They also happen to be the most Draconian to all who are pain management regimens that include the popular synthetic opiates like Vicodin (hydrocodone) and Percocet (oxycodone).
Because each pill of these narcotics is paired with 500mg of acetaminophen, and many of the acetaminophen overdoses occur in populations who overuse these medicines, the FDA came up with a brilliant solution: take the drugs off the market.
Yep, that's right. Rather than require drug companies to reformulate their compounds with half the acetaminophen they use, the FDA wants to toss the baby out with the bath water by pulling these helpful drugs off the market.
Just exactly are the tens of millions of chronic pain sufferers going to take now? They offer no recommendation.
A Food and Drug Administration panel on Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market.
The FDA has assembled a group of experts to vote on ways to reduce liver damage associated with acetaminophen, one of the most widely used drugs in the U.S.
Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., according to the FDA.
Panelists cited FDA data indicating 60% of acetaminophen-related deaths are related to prescription products. Acetaminophen is also found in popular over-the-counter medications like Tylenol and Excedrin.
"We're here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact," said Dr. Judith Kramer of Duke University Medical Center.
But many panelists opposed a sweeping withdraw of products that are so widely used to control severe, chronic pain.
"To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake," said Dr. Robert Kerns of Yale University.
Kerns got it right. Glad to see that not all of them have their butts up their tailpipes.
In a separate vote, the panel voted overwhelmingly, 36-1, that if the drugs stay on the market they should carry a black box warning, the most serious safety label available.
Many of you still remember the Great Nationwide Oxycodone shortage of 2009? For the first time and over a period of four months, America had a very "painful" Oxycodone shortage that ended last month.
Millions of people paniced as they scramled for other products that were sitable substitutes for oxycodone, such as hydromorphone, Dilaudid, and Vicodin and Percocet.
The obly reason why drug companies like to combine Tylenol/acetomoniphen to an opiate like Vicodin (hydrocodone) and Percocet (oxycodone) There is only one reason why drug companies combine acetomoniphen: LESS OPIATE + MORE ACETOMINOPHEN = BIGGER PROFITS. From a Cost-Buying perspective, drug companies should be making oxycodone and Hydrocodone available by itself. If people who are being prescribed Pre So, they are telling us that we my have to carry around our Schedule II drugs in "black boxes" that will be make them readily spotted by every junkie and crack whore in the store with you. Good luck getting them and yourself home in one piece
I have a family member with severe chronic pain and three terminal diagnoses. Nothing touched his pain, Oxycodone, + Fentanyl patches- nothing. He was finally prescribed something that completely took away his pain and did not make him loopy or sedated. Methadone. I don't know how safe it is compared to other drugs, but it works for my relative like nothing else did and he no longer acts "all doped up".