My, oh, my…how will we survive without our Vicodin and Percocet? A panel of government-assembled experts ended the month of June with expansive, albeit controversial, safety reforms for our most popular painkiller, acetaminophen. They also pushed for a ban on prescription Vicodin and Perocet.
The esteemed 37 authorities convened to brainstorm how we can reduce lethal acetaminophen overdoses– the premier cause of liver failure in the U.S. An estimated 56,000 people land in the emergency room each year and about 200 of them die.
Vicodin and Percocet (depending upon the strength) contain not only hefty doses of acetaminophen, but an opiate narcotic too. The FDA group wavered on completely eliminating these drugs although they were concerned that 60 percent of acetaminophen-related deaths were linked to prescription items. The dangers from use or abuse of Vicodin and Percocet could be ‘more concerning,’ one panelist said.
A staggering 200 million prescriptions were written last year for acetaminophen combination drugs, according to the FDA. “If we don’t eliminate the combination products we should at least lower the levels of acetaminophen contained in those medicines,” said Sandra Kewder, FDA’s deputy director for new drugs.
Dr. Lewis S. Nelson, chairman of the FDA’s Drug Safety and Risk Management Advisory Committee explained the panel’s 20-17 vote to ban prescription acetaminophen/opiate drugs. “There are many deaths that relate to problems with prescription opiate combination acetaminophen products, whereas the number of deaths clearly related to the over-the-counter products are much more limited.”
The panel’s consensus seems to be that if combination drugs are discarded, the acetaminophen and other ingredients, such as oxycodone, could be prescribed separately. Thus, patients would take two pills instead of one, and be “more aware” of how much acetaminophen they’re taking.
Hmmm. Would this really work? Or would the patient take two pills of each, assuring that they’re receiving an ample dose?
“The panel recommending banning Vicodin and Percocet seems a little draconian,” said Les Funtleyder, an analyst for Miller Tabak & Co. Others concur.
“The problem isn’t that the patient doesn’t understand the Vicodin dosage directions. He wants quick relief so he takes two pills instead of one,” says pharmacist Rick Meyer. “No matter what the warning, some people think it doesn’t apply to them. This won’t change no matter what the FDA or its panel says.”
With Vicodin and Percocet’s fate sealed, the advisory posse tackled other acetaminophen issues. It was a two-day meeting. “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.
An FDA report concluded that many people consume more than the recommended dose of painkillers, assuming more is better and their health will not be affected by doing so. Also, consumers might not know that acetaminophen is present in many over-the-counter remedies for colds, flu, headache, and fever. So the imbibers of these products again, might ingest too much acetaminophen.
Based on that report, the FDA advisory panel recommended 21-16 to lower the current maximum daily dose of over-the-counter acetaminophen from 4 grams, or 8 pills such as Extra Strength Tylenol. They didn’t specify how much it should be lowered though.
They also suggested limiting the maximum single dose to 650 milligrams…down from the 1,000-milligram dose, or two Extra Strength Tylenol tablets. Most of the group said the 1,000-milligram dose should be prescription only.
Interestingly, the advisers voted against other over-the-counter safety restrictions for drugs such as NyQuil and Theraflu, which contain acetaminophen and other cough and runny nose ingredients. Patients often take both Tylenol and cold medications when they’re feeling miserable exposing them to dangerous levels of acetaminophen.
Maybe this topic came up at the end of day two.
Was this bureaucratic convergence a productive use of our tax dollars? At least 37 people thought it was.