This is a game changer. If they ban the hydrocodone/APAP combinations, that will be the end of Schedule III hydrocodone. JP thinks this would be a good thing. If MDs want to run “Prescription Mills” I want their DEA recorded with each Rx. Here is the whole magilla if you want to read it.
FDA urged to ban popular painkillers
A federal advisory panel voted narrowly Tuesday to recommend sweeping safety restrictions on widely used painkillers, including reducing the maximum dose of Tylenol and eliminating prescription drugs such as Vicodin and Percocet, because of their effects on the liver.
ADELPHI, Md. — A federal advisory panel voted narrowly Tuesday to recommend sweeping safety restrictions on widely used painkillers, including reducing the maximum dose of Tylenol and eliminating prescription drugs such as Vicodin and Percocet, because of their effects on the liver.
The two drugs combine a narcotic with acetaminophen, the ingredient found in popular over-the-counter products like Tylenol and Excedrin. High doses of acetaminophen are a leading cause of liver damage.
Acetaminophen is combined with different narcotics in at least seven other prescription drugs, and all of these combination pills will be banned if the Food and Drug Administration (FDA) heeds the advice of its experts.
Vicodin and its generic equivalents alone are prescribed more than 100 million times a year in the United States.
Acetaminophen is included in a vast array of over-the-counter cough and cold products, including Nyquil, Excedrin and many others. A small share of accidental poisonings result when people take two or more of these combination products without understanding the peril.
Laureen Cassidy, a spokeswoman for Abbott Laboratories, which makes Vicodin, said, “The FDA will make a final determination, and Abbott will follow the agency’s guidance.”
The agency is not required to follow the recommendations of its advisory panels, but it usually does.
The panel’s 20-17 vote to recommend a ban on the combination prescription drugs was one of 11 it took at a meeting called to advise the FDA on problems arising from the extraordinary popularity of acetaminophen. In 2005, U.S. consumers bought 28 billion doses of products containing the ingredient.
While the medicine is effective in treating headaches and reducing fevers, even recommended doses can cause liver damage in some people. And more than 400 people die and 42,000 are hospitalized every year in the United States from overdoses.
In hopes of reducing some of these accidents, the committee voted 24-13 to recommend that the FDA reduce the highest allowed dose of acetaminophen in over-the-counter pills like Tylenol to 325 milligrams, from 500. And members voted 21-16 to reduce the maximum daily dosage to less than 4,000 milligrams.
But they voted 20-17 against limiting the number of pills allowed in each bottle, with members saying such a limit probably would have little effect and could hurt rural and poor patients. Bottles of 1,000 pills are often sold at discount chains.
“We have no data to show that people who overdose shop at Costco,” said Dr. Edward Covington, a panel member from the Cleveland Clinic Foundation.
Some doctors already avoid prescribing pills that combine acetaminophen with narcotics like oxycodone (found in Percocet) and hydrocodone (in Vicodin).
“It ties the doctor’s hands when you put the two drugs together,” said Dr. Scott Fishman, a professor of anesthesiology at the University of California, Davis, and a former president of the American Academy of Pain Medicine. “There’s no reason you can’t get the same effect by using them separately.”
He said the combinations were prescribed so often for the sake of convenience but added, “When you’re using controlled substances, you want to err on the side of safety rather than convenience.”
Still, some doctors predicted the recommendation would put extra burdens on physicians and patients.
“More people will be suffering from pain,” said Dr. Sean Mackey, chief of pain management at Stanford University Medical School. “More people will be seeing their doctors more frequently and running up health-care costs.”
In a statement, Johnson & Johnson, Tylenol’s maker, said it “strongly disagrees” with the proposed restrictions on acetaminophen, adding that they would be likely to “lead to more serious adverse events as consumers shift to other over-the-counter products,” such as ibuprofen and aspirin.
Linda Suydam, president of the Consumer Healthcare Products Association, said the committee ignored studies showing that doses sold by her members — two pills of 500 milligrams, up to four times a day — were safe.
“I think this is a very effective dose and one needed for individuals who experience chronic pain,” she said.
The committee also turned its attention to over-the-counter children’s medicines containing acetaminophen, voting 36-1 to limit them to a single formulation. Right now the liquids are sold in two different concentrations, leading to confusion among doctors and parents.
The FDA asked the committee whether it should ban combination products that include acetaminophen. The vote was 24-13 against such a ban, with many members saying consumers saw the products as valuable.
“Based on the data provided, the combination OTC [over-the-counter] medications really contributed very little to overall poisonings,” said Dr. Osemwota Omoigui, a panel member from the Los Angeles Pain Clinic.
The panel voted 36-1 to recommend that the prescribing information for such products include a boxed warning, the agency’s most urgent caution, about liver dangers.