>As reported recently on ABC News, a scientific panel of experts has made a series of recommendations to the U.S. Food and Drug Administration (FDA) concerning the painkiller acetaminophen, including the need for stricter warnings on prescription drugs that combine acetaminophen with hydrocodone (Vicodin), oxycodone (Percocet), and codeine (Tylenol 3), as well as the possibility of an outright ban of some these medications.
The panel also believed that tighter regulations were in order for the over-the-counter (OTC) versions of acetaminophen, which would include switching the strongest dosage (1000 mg) to prescription status, placing a cap of 650 mg on the maximum available dose without a prescription, and lowering the recommended maximum daily adult dose, which is currently at 4000 mg/day. The FDA is not under any obligation to adopt the findings and a final decision is probably months away.
The news comes just a little over a month after the FDA called for drug makers to provide more extensive label warnings on many of their OTC medications. This would entail clearer disclosure of certain ingredients as well information regarding their health risks, including liver damage from acetaminophen and stomach bleeding from a variety of non-steroidal anti-inflammatory drugs (NSAIDs) that include aspirin, ibuprofen, naproxen, and ketoprofen.
The current climate of concern is partly in response to the over 42,000 people who are admitted each year to the emergency room for acetaminophen overdoses, almost half of which are because they simply don’t know how much of the drug they are taking. In fact, many people are not aware that it is a common ingredient in many medications, including pain relievers, cough medicines, and fever reducers. When a person takes them in combination with acetaminophen, they are unknowingly taking a larger dose than they realize, raising their risk for overdose and liver failure. These problems underlie the current actions taken by the FDA.
Reaction in the medical community has been mixed, with responses often falling along the respective lines of expertise. Liver specialists have applauded the findings, citing the fact that acetaminophen poisoning is the most common cause of acute liver failure in this country, killing more people each year than all prescription medication combined.
However, pain management doctors, including oncologists, family practitioners and rheumatologists, while acknowledging the need for increased awareness, indicate that many of these medicines are useful and effective in combating chronic pain and should not be eliminated.
Meanwhile, advocates for the drug manufacturing industry, including McNeil Consumer Healthcare, the makers of Tylenol, have expressed concern that the decisions might discourage people from turning to what has been, when used properly, a safe and effective pain reliever for the past half century. They also cite the FDA finding that a majority of the acetaminophen fatalities (both prescription and OTC) were in fact intentional overdoses, i.e. suicide attempts. Therefore, targeting acetaminophen might in fact be misguided in that it is not addressing the root cause of many of these deaths.
Whatever the FDA decides, it is safe to say that acetaminophen is not going away any time soon. With over 28 billion doses bought by American consumers in 2005, 10 billion of which were OTC products, it is the most commonly used painkiller in this country.
Which simply highlights the public’s need to be informed. As a patient and a consumer, the impetus lies with us. Make sure to pay close attention to the ingredients in your medication, and in the event that you have any doubts whatsoever, do not hesitate to ask your physician or pharmacist. Your health, and for that matter, your life could depend on it.