Case Info
Tylenol Drug Injury
Tylenol, the popular brand name of acetaminophen is one of the most commonly used drugs in country. Tylenol is available over the counter and is used as both a pain reliever and fever reducer. Acetaminophen is often combined with other drugs to create combination painkillers designed to make narcotics less abusable and addicting. Unfortunately, this method of abuse control was ineffective and has been proven to be dangerous.
After industry recognition that acetaminophen may increase the risk of liver damage when combination opioid medications are abused, many manufacturers chose to decrease the amount of Tylenol in some products. Newer medications also contain lower doses of acetaminophen, but it is still used as an ingredient in medications like Percocet, Vicodin, Norco, and Tylenol with Codeine. More than 200 million prescriptions are written every year in the United States for these combination drugs.
Over-the-counter medications with acetaminophen as an ingredient may also be a serious concern for risk of liver damage, particularly if too much is taken or if the medications are combined with others that also contain acetaminophen like Tylenol Cold and Tylenol Sinus.
Tylenol and Liver Damage
Over-the-counter medications with acetaminophen as an ingredient may also be a serious concern for risk of liver damage, particularly if too much is taken or if the medications are combined with others that also contain acetaminophen like Tylenol Cold and Tylenol Sinus.
Tylenol is assumed to be a safe drug when taken as directed. However, its use as a pain reliever has fallen over time. This is in part due to the availability of alternative medications such as ibuprofen, but also due to increasing knowledge about the possibility of liver damage. Health care professionals have known for decades about the dangers of Tylenol overdose and long-term liver damage, but public awareness of the risks has only begun to increase in the recent years.
Tylenol-related liver damage is caused by metabolism of the medication which occurs in the liver. Liver damage may occur when a large dose is taken at one time. It may also occur when the medication is taken at moderate doses over an extended period of time. Liver damage may be worsened when it is taken with or at the same time alcohol is ingested.
The maximum daily amount of acetaminophen was reduced in 2011 when the recommended amount on over-the-counter labels was changed from 4000mg to 3000mg for most products. On January 13, 2011, the Food and Drug Administration required drug manufacturers to limit the amount of acetaminophen in prescription medications to only 325 milligrams per dose. Before this restriction was put into place, many prescription medications contained upwards of 750mg of acetaminophen per dose.
The FDA also mandated that all prescription products containing acetaminophen must bear their most severe “Black Box” warning and OTC manufacturers were ordered to include liver damage warnings on labels.
Tylenol and Suicide Deaths
Even though acetaminophen is considered “safe” at normal doses for short-term use, it is considered by many to be one of the most dangerous drugs ever marketed due to potential liver damage from both chronic use and overdose. When Tylenol is taken as a “suicide” drug, it is often fatal, even in cases where the patient believed it was only a “gesture” intended to garner attention.
Each year in the U.S., thousands of hospitalizations and hundreds of suicide deaths are caused by ingestion of Tylenol. Tylenol overdose is not immediately fatal, unlike other drugs. Death occurs due to severe liver failure which progresses over a period of days or weeks and is due to the liver being “overwhelmed” by Tylenol.
If discovered in time, liver damage may be mediated by use of a “rescue” drug called Mucomyst or acetylcysteine. Mucomyst is a medication normally used as an inhalant in certain lung conditions, but when given orally, it works to reduce Tylenol overdose fatality by slowing acetaminophen metabolism in the liver.
Mucomyst’s Tylenol antidote regimen requires that dosing be started within 24 hours after ingestion of acetaminophen, and dosing should begin as early as possible. It must be given as a large, initial, or loading dose followed by maintenance doses every 4 hours over a period of 3 days, for a total of 17 doses. If a dose is vomited, it must be repeated and must be given by gastric tube if the patient cannot swallow or keep from vomiting, as maintenance levels are critical for treating Tylenol overdoses.
In most cases, dosing must be completed in the hospital as frequent monitoring of liver and kidney function will also be required. Even when acetylcysteine is given as directed, there are no guarantees that liver damage, even death, will not occur.
Patients Taking More Acetaminophen Than They Realize
Though manufacturers recommend that people not take more than 3000mg of acetaminophen per day, many people inadvertently take more. Users often mistakenly take more than the advised limit because they may be taking more than one medication that contains acetaminophen without realizing it. Many products list “APAP” – an abbreviation for acetaminophen – as an ingredient instead of the full drug name.
Dosage recommendations also state that Tylenol should be taken only for a short period of time. In fact, taking the maximum amount can result in liver impairment in just four days for some patients. A study performed by scientists at the University of North Carolina, Chapel Hill, and published in the Journal of the American Medical Association, showed that up to 44% of all participants who took acetaminophen over a period of two weeks—whether alone or in combination with another drug—experienced abnormal elevations of a certain liver enzyme that is a precursor to liver damage.
Further studies have shown that around half of all reported cases of liver failure, roughly 800 a year, are caused by an overdose of acetaminophen.
Tylenol Liver Damage Lawsuits
Hundreds of lawsuits have been filed against McNeil and its parent company, Johnson & Johnson, for liver damage and deaths associated with Tylenol use. In February of 2017, Johnson & Johnson agreed to settle over 200 Tylenol lawsuits for an undisclosed amount. The company also agreed to pay about $33 million to 42 states and the District of Columbia for claims that it had overstated the characteristics and quality of Tylenol and other over-the-counter medications they manufacture.
Though most of the Tylenol liver damage lawsuits have reached conclusion, Johnson & Johnson may be facing thousands of lawsuits for other conditions which may be caused by acetaminophen. Other Tylenol lawsuits have been filed for children diagnosed with attention deficit hyperactivity disorder (ADHD) or autism spectrum disorder (ASD) which may be linked to maternal Tylenol use during pregnancy.
*Prior results do not guarantee or predict a similar outcome in any future matter.