Tylenol total dosages particularly when mixed with alcohol equal liver stress. Many are lulled into believing this is not even a drug! Tylenol kills yet they have the audacity to market it as the safe aspirin alternative for years! This drug also needs a large warning about synergistic toxicity when consumed with alcohol. It is a favorite choice in England for suicide.
This restriction is way overdue! I need to have more of you purchase http://www.rxwise.com
so that you will know IN ADVANCE what dangers your patients face gambling with polypharmacy. I just had a friend explain that his mother finally became so ill she was admitted to hospice! The doctors there discontinued most of her meds! Within a few days she was well and could go back home and start living again. Please understand that when anyone is consuming 5 or more prescriptions the possibility of serious adverse reactions is very large, and soon the potential of malpractice may develop.
Garry F. Gordon MD,DO,MD(H)
President, Gordon Research Institutehttp://www.gordonresearch.com
The Unsafe Side of Acetaminophen - WSJ.comhttp://online.wsj.com/article/SB10001424052970203577304574272292331942618.html#mod=djemHL
•JULY 10, 2009, 10:23 A.M. ET
Taking Pains With a Painkiller
As FDA Weighs Limits on Acetaminophen, Consumers Must Stay Alert to Prevent an Overdose
Whether or not the Food and Drug Administration decides to limit sales of acetaminophen, consumers should know this:
It’s easy to take more than the recommended daily dose without realizing it.
The margin between a safe dose and a potentially lethal one is small.
The first symptoms of acute liver failure caused by an overdose seem like the flu and don’t set in for several days, by which time it may be too late to save your liver and consequently your life.
That’s what happened to Rebecca Drake’s 23-year-old sister, April, who was taking an acetaminophen product for acid reflux. Ms. Drake, a pharmacist, told an FDA advisory panel last week that April kept taking more and more to control pain. She suffered acute liver failure and died last year, despite a last-minute liver transplant.
Such unintentional overdoses prompted the panel to recommend sweeping limits on acetaminophen, including lowering the maximum daily dose to 2,600 milligrams from 4,000 mg and limiting the amount in a single over-the-counter pill to 325 mg, from 500 mg currently. The panel also recommended banning sales of prescription pain relievers that combine opioids with acetaminophen, including Percocet and Vicodin, among the most widely prescribed drugs in the U.S. If the full FDA follows the panel’s advice, it could have a major impact on the multibillion-dollar pain relief industry and the U.S health-care system at large.
Message boards quickly lit up with complaints that the FDA shouldn’t deprive millions of people of needed pain relief. Johnson & Johnson’s McNeil Consumer Healthcare unit, maker of Tylenol, reminded consumers that its product is safe at the recommended dosages and that alternative over-the-counter products like aspirin and ibuprofen have side effects of their own.
To be sure, acetaminophen-related liver problems occur in just a tiny fraction of the drug’s users, causing 450 deaths and 56,000 emergency-room visits a year. Americans purchased more than 28 billion doses of acetaminophen in 2005, and roughly 19% of the U.S. adult population uses some form of the medication in a given week.
Acetaminophen has grown in popularity in large part because of its reputation for safety. For generations, Tylenol ads have painted it as “the pain reliever hospitals use most.” Acetaminophen is in more than 300 over-the-counter and prescription products, from headache and cold remedies to cough syrup and sleep aids.
But pain experts say that reputation for safety may be lulling consumers into complacency. Some consumers don’t think twice about popping more than the recommended amount and don’t bother to read the ingredients on familiar over-the-counter products. “The problem is it’s sneaking up on people,” says Judith Kramer, an associate professor of medicine at Duke University, who was on the FDA advisory panel. She also notes that there has been considerable “dose creep” over the years. “It’s difficult to even find regular strength [325 mg] Tylenol. All you see is the [500 mg] Extra Strength.”
Some pain specialists say it’s hard to get patients to focus on how much acetaminophen they are taking. “It’s safe as instructed—but if you’re taking Percocet for your lower back pain, and Tylenol for your headache, and cough syrup three times a day and then you can’t sleep so you take an over-the-counter sleep aid, you are taking a lot more than you are aware of,” says Timothy A. Collins, a neurologist with the Duke University Pain and Palliative Care Clinic.
“Some people don’t even consider Tylenol a drug, so they don’t tell their doctors,” says Roger Chou, a pain specialist at Oregon Health and Sciences University and author of the American Pain Society’s guidelines on opiates.
Opinions vary about what constitutes a safe level. Many experts agree that a daily dose of 7,000 mg can cause severe liver damage in an adult. But about 10% of the acetaminophen-related deaths have occurred at levels between 2,000 mg and 4,000 mg. People who drink three or more alcoholic beverages a day or have liver disease are particularly vulnerable.
Doctors can administer an antidote to an acetaminophen overdose, but it must be done within 12 hours, which may be well before symptoms have set in. And even though the liver is capable of regenerating from some injuries, that’s not the case with acetaminophen poisoning. “Every cell is being damaged at once,” says Duke’s Dr. Collins.
Adding acetaminophen to opioids in prescription pain relievers has boosted their popularity, and potential problems. The combination of acetaminophen and not allowed in Abbott Laboratories’s Vicodin and its generic cousins is classified as a Schedule 3 drug under the Controlled Substances Act. That allows doctors to prescribe it by phone and write multiple refills, unlike other opioids that require a new prescription every month.
Many such combinations contain five mg of the opioid and 500 mg or 750 mg of acetaminophen. Patients who develop a tolerance to the opioid and take more and more to get relief can end up getting a big dose of acetaminophen. “We all think, gosh, it’s the narcotic that’s dangerous, but there is a separate level of concern about the acetaminophen that many doctors don’t tell their patients about,” says Sandy Kweder, the FDA’s deputy director for new drugs.
Even conscientious patients may not be aware of how much acetaminophen is in their prescription pain reliever because it is often labeled as APAP—an acronym for its chemical name, N-acetyl-para-aminophenol. The FDA in 2004 asked state pharmacy boards, which oversee labeling for prescription drugs, to require acetaminophen to be listed by name on the bottle, but so far, none have complied.
Some pain experts say acetaminophen, which is a weak analgesic, doesn’t add much to the opioids anyway. And separating the ingredients in the drugs would allow patients to take more opioid without the added liver risk. Although not allowed is available in combination with ibuprofen, also made by Abbott, it is currently not available by itself. And any new version would likely require FDA approval as a new drug. In the meantime, more patients might turn to substitutes such as oxycodone, the opiate in Percocet, which is available in a single formula.
“People will have to switch to other drugs, and what are the side effects of those?” says Knox Todd, who also served on the FDA advisory panel. He notes that ERs like his at Beth Israel Medical Center in New York regularly see more cases of kidney failure, gastrointestinal bleeding and hypertension related to non-steroidal anti-inflammatory medications including ibuprofen and aspirin than liver problems. Side effects from NSAIDs result in more than 100,000 hospitalizations and thousands of deaths each year in the U.S. Taking these drugs with food can lessen the problems, but some people are particularly sensitive.
This isn’t the first time the FDA has grappled with the acetaminophen problem. In 2002, an advisory panel recommended that over-the-counter products containing the drug be clearly labeled on the front of the package. But it took until December 2006 for the FDA to propose such a rule, and until April 2009 for it to go into effect. The FDA also launched a public education campaign to help consumers understand the danger, but it appears to have had little effect.
It’s likely the FDA will take some action. “But we have to proceed judiciously,” Dr. Kweder says. Some experts say the FDA is more likely to limit the amount of acetaminophen in prescription combinations than ban them entirely. But any possible action is likely to take years.
In the meantime, consumers should check for acetaminophen levels, even on products they have used for years. “Consumers should not be afraid to take this medicine,” says Dr. Kweder. “But be careful if you have liver problems or drink a lot of alcohol and make sure you are not taking more than one product that contains the same ingredient.”