Thousands of Americans take Tylenol (acetaminophen) every day for headaches, muscle aches, arthritis, and other common ailments. Many of them, however, are unaware of a serious complication of taking too much”acetaminophen acute liver failure.
For many years, the maximum recommended dose has been 4,000 milligrams (4 grams), which equals about eight extra-strength (500 mg) pills a day. Research has shown, however, that certain populations are at risk of liver problems even at that dose, while other evidence points to unintentional overdoses where individuals inadvertently take more than one product that contains acetaminophen.
The FDA has recently taken action to limit the dose of prescription acetaminophen products, but has not yet enforced such limitations on over-the-counter products, which can contain up to 650 mg per tablet for extended-release versions. Manufacturer Johnson & Johnson, however, is finally taking some steps to limit maximum dosages and increase consumer awareness. Those who have been injured by the drug and have filed an acetaminophen lawsuit claim the company should have taken such steps years ago.
Studies Show a Rise in Acetaminophen Acute Liver Failure
Back in 1977, an FDA advisory committee recommended that all acetaminophen-containing products contain warnings alerting consumers to potential acetaminophen acute liver failure. At the time, the FDA ignored the advice.
Over the last couple of decades, however, studies have shown that incidences of liver failure related to the pain reliever are increasing. Researchers analyzing national databases in 2006, for example, reported in the journal Pharmacoepidemiology and Drug Safety that acetaminophen-related overdoses account for about 56,000 emergency room visits and 26,000 hospitalizations annually, with over 450 deaths. The poison surveillance database showed a near doubling in the number of fatalities associated with acetaminophen from 1997 to 2001.
According to an earlier study published in Hepatology in 2005, cases of acetaminophen acute liver failure rose from 28 percent in 1998 to 51 percent in 2003. Unintentional overdoses accounted for 48 percent of those cases.
Why the Increase?
Though it’s not yet clear why we’re seeing more cases of liver failure from acetaminophen, scientists have some theories. First, according to research, more than a third of those who experienced an unintentional overdose took at least two products containing acetaminophen. The availability of cold and flu products in addition to pain-relievers means that people have more choices than ever for dealing with uncomfortable symptoms, yet they may not always be aware that they’re doubling up on some medications.
In addition, when individuals take acetaminophen with alcohol, they increase their risk of acetaminophen acute liver failure. Others risk factors include:
- Type II diabetes
- Combining acetaminophen with other medications, including some herbal supplements
- Taking the drug while fasting
- Being over the age of 65
- Having liver disease
FDA Takes Action
On June 13, 2011, the FDA announced that all prescription drugs containing acetaminophen would limit the amount to 325 milligrams per tablet, and would add black-box warnings concerning the risk of liver injury. The agency has so far placed no such limitations on over-the-counter drugs, however, even though an expert panel recommended in 2009 that the recommended dose be lowered to no more than 3,250 mg.
Johnson & Johnson, however, lowered the maximum dose on Extra Strength Tylenol from 8 pills (4,000 mg) to 6 (3,000 mg), and have launched a national initiative to educate consumers about the appropriate use of the drug. Meanwhile, those who have already been injured and have filed an acetaminophen lawsuit feel the actions have come much too late.
An Acetaminophen Lawyer Can Help
Manufacturers have known about the potential for acetaminophen liver failure for years, yet have failed to do enough to warn about the risks. If you or a loved one has suffered from liver problems as a result of using Tylenol or another acetaminophen medication, you may be entitled to compensation. The attorneys at Chaffin Luhana LLP are well educated in acetaminophen-related injuries, and are ready to help you. Call today for a free and confidential case evaluation at 1-888-480-1123.