The popular over-the-counter pain reliever, Tylenol has been linked to severe liver damage, liver failure and death.
Tylenol Drug Injury
Tylenol, the most popular brand name of acetaminophen is one of the most commonly used drugs in country. Tylenol, with the active ingredient acetaminophen, is available over-the-counter and is used as a pain reliever and fever reducer. Acetaminophen is often combined with other drugs to create a combination painkiller which was designed to make narcotics less abusable and addicting. Unfortunately, this method of abuse control was ineffective and 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.
Tylenol and Liver Damage
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 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 live damage, but public awareness began to increase in the recent past.
Tylenol can result in liver damage because metabolism of the medication is done in the liver. Liver damage can occur when the medication is taken at moderate doses over a long period of time. It may also occur when a large dose is taken at one time. Liver damage is worsened when it is taken with or at the same time as 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 liver damage from both chronic 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 normally a medication used as an inhalant in certain lung conditions but when given orally, it works to reduce Tylenol overdose fatality by slowing acetaminophen’s clearance in the liver.
Mucomyst’s Tylenol antidote regimen requires that dosing be started within 24 hours after ingestion of acetaminophen, earlier if possible. It must be given as a large, initial or loading dose followed by maintenance doses every 4 hours for 17 doses, or over a period of 3 days. If a dose is vomited, it must be repeated and must be given by gastric tube if patient cannot swallow or keep from vomiting as maintenance levels are critical.
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 4 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 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 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 these lawsuits have reached conclusion, Tylenol is still known to be a dangerous drug and as such, lawyers at Seeger Weiss will remain watchful.