What is Tylenol?
Tylenol is the original brand name of the generic medication, acetaminophen, also known as paracetamol. It is likely, the most well-known brand names in over-the-counter pain relief medications. Due to the recall history, some retailers have limited stock levels of Tylenol products, offering generic versions instead but even though acetaminophen is widely available by generic manufacturers, worldwide sales of Tylenol continue to top $1 billion each year.
While Tylenol can be found in the majority of America’s medicine cabinets and is thought to be safe, the drug can cause significant side effects. Acetaminophen, the active ingredient in Tylenol is also in all of the Tylenol cough and cold products, as well as many other combination cough/cold remedies and many prescription pain relievers. Research shows that acetaminophen is one of the leading causes of liver damage and liver failure in the United States and around the world.
Tylenol was introduced in 1955 by the McNeil Laboratories pharmaceutical company. The first product was a liquid elixir for children which was only available as a prescription. By 1959, McNeil Laboratories was acquired in 1959 by Johnson & Johnson, the largest pharmaceutical company in the world and Tylenol Elixir for Children was widely used in both children and adults. Regular-Strength Tylenol tablets for adults were released in 1961.
By 1961, Tylenol was the number-one painkiller in the United States market. The Food and Drug Administration suggested that a “severe liver damage” warning be placed on acetaminophen products in 1977 however the recommendation would not actually be adopted for 32 years – in 2009.
Today, Tylenol brand medication still sells at a rate of $1 billion per year or more, not including generic acetaminophen products or similar products in other countries which are sold under the generic medication name “paracetamol”.
Side Effects and Drug Interactions of Tylenol
Though Tylenol is considered to be safe by most consumers, like most medications, Tylenol may cause side effects and interactions with a number of medications. The majority of interactions and the most severe adverse event, liver damage are due to Tylenol’s action on the liver.
Common side effects of Tylenol include:
- Stomach upset
When taken frequently for headache, if discontinued, “rebound headache” may occur which often results in more of the medication being taken than may be safe.
Due to its toxic effects on the liver, Tylenol has drug interactions such as:
- Over-the-counter cough and cold medication containing acetaminophen
- Prescription pain relievers that contain acetaminophen such as Vicodin, Darvocet, Norco, Percocet, Tylenol with Codeine, Fioricet
- Anticonvulsants and other medications that affect the liver such as Dolobid (diflunisal) and Isoniazide
- Oral anticoagulants such as Coumadin (warfarin) – may increase the risk of bleeding
Alcohol is also known to be damaging to the liver and should never be used at the same time. People who consume alcohol should limit their use of Tylenol or other products containing acetaminophen.
Studies Link Tylenol to Liver Damage
A number of studies have shown that acetaminophen is a significant cause of liver damage both from long-term use and acute overdose. Roughly 200 acetaminophen deaths per year are reported. In addition, roughly 56,000 emergency room visits are attributed to acetaminophen overdose.
Excessively high doses of acetaminophen due to accidental overdose or intentional overdose from suicide attempt, can result in acute liver failure and death. If acetaminophen overdose does not receive immediate medical attention, it may result in death for the patient.
Long-term use of high doses may lead to chronic liver damage which can result in cirrhosis, liver cancer or chronic liver failure and eventual death. Liver damage rates may be significantly higher if patients consume alcohol in conjunction while taking acetaminophen.
Liver damage in the beginning stages is often hard to detect but some early symptoms of liver damage may include:
- Abdominal pain
- Loss of appetite
In the later stages, symptoms that show significant liver damage may include:
- Yellowing of the skin
- Yellowing of the “whites” of the eyes
- Dark Urine
- Pale Feces
- Abdominal swelling
- Itchy skin and unusual rash
- Easy Bruising
Very advanced liver damage symptoms may indicate liver failure or cirrhosis (liver cell death) and include:
- Edema – fluid accumulation in the legs or abdomen
- Mental confusion or coma
- Kidney failure
- Gastrointestinal bleeding
- Increase in bacterial infections.
Any symptoms of liver damage should be reported to a physician, significant liver symptoms should be attended to immediately. Liver damage can ultimately lead to death.
Tylenol is one of the most common medications used for intentional overdose. It is often taken as an intended “suicide gesture” where the patient was not actually intending to take something that would result in death but was looking for immediate attention. Unfortunately, Tylenol overdose can be fatal. There is an antidote which may work but it must be started immediately and is not always completely effective. Even if death is prevented, the patient is often left with severe liver damage.
Prescription pain medications containing acetaminophen are often taken more often than prescribed. In addition, many patients taking prescription medicine or over-the-counter cold medicine will also take Tylenol. Taking too much acetaminophen whether it is a prescription, a cold medication or Tylenol over-the-counter medication will result in liver damage.
Tylenol Manufacturing Issues
In September 1982, seven deaths were caused by Tylenol in a case of criminal tampering. Bottles containing the Extra-Strength Tylenol capsules were not protected with safety-seals allowing the capsules to be laced with cyanide after they had been placed on store shelves. Tylenol sales plummeted, but Johnson & Johnson took initiative and recalled 31 million Tylenol bottles in response to the tampering crime. Within a year, Johnson & Johnson had redesigned the packaging and capsules themselves and sales were nearly back to normal. The new design included gel-coated, solid core capsules and a new triple-sealed, tamper-proof package design.
In 2010, Johnson & Johnson voluntarily recalled 43 over-the-counter medications produced by the subsidiary McNeil Consumer Healthcare. This included Tylenol and Tylenol Plus along with other popular allergy and cold medications and affected at least 12 countries. The recall was instigated due to manufacturing deficiencies with some products containing varying amounts of active ingredients and possible foreign materials such as metal specs, solidified material or mold.
In 2011, approximately 60 thousand bottles of extended release Tylenol caplets were recalled due to a “moldy” small and possible chemical contamination and infant Tylenol drops were recalled due to a higher than stated concentration of acetaminophen.
In July of 2011, Johnson & Johnson announced plans to reduce the maximum daily recommended amount of Extra-Strength Tylenol from eight pills per day (4000 mg) to six pills per day (3000 mg). The company claimed the change was to avoid potential liver damage, though the FDA warning requirement regarding liver toxicity had come two years earlier and the FDA had discussed the possibility of liver damage in 1977.
In 2012, over 500 thousand bottles of children’s Tylenol liquid were recalled after parents reported difficulty administering the medication, resulting in accidental ingestion. The medication formulation has since been changed.
McNeil Consumer Products and the parent company, Johnson & Johnson has repeatedly opposed safety warnings, dosage restrictions and warnings about using Tylenol and alcohol.
From 2009 to May 2012, Johnson & Johnson issued 26 separate recalls on various products, including varieties of:
- Sudafed PE
- Simply Sleep brands
- St. Joseph’s Children’s Aspirin
- Tylenol Products
In May 2017, Johnson & Johnson paid $33 million to settle a lawsuit with 42 states and the District of Columbia for violation of consumer protection laws. The company agreed not to claim that it meets “standards of practice” as established by the FDA if any of its consumer OTC medications had been subject to recall in the previous 12 months.
Johnson & Johnson has faced numerous lawsuits filed by consumers, parents or loved ones of those who were injured or who died after a liver injury caused by Tylenol.
Instructions for Tylenol use for adults once included a maximum dosage of 4,000 mg/day, a higher dosage level than is now considered safe. Tylenol dosing recommendations are now limited to 3,000 mg per day in divided doses for adults and 75mg/kg per day for children. Unfortunately, many consumers and even health professionals use Tylenol at higher than the reduced recommended doses.
Notable lawsuits that have been filed against Johnson & Johnson include:
- Liver Failure and Transplant – In 1994, Antonio Benedi of Virginia was awarded $8.8 million after a combination of Tylenol and regular consumption of wine at dinner resulted in liver loss. Of the total award, $7.8 million was for compensatory damages and the remaining $1 million was for punitive damages. Benedi was President George Bush’s appointments and scheduling secretary. After several days of taking Extra Strength Tylenol for the flu and drinking wine with dinner, Benedi became comatose. His liver was transplanted after doctors discovered liver failure.
- Infant Death – Illinois parents Malgorzata and Michael Cherry filed a Tylenol lawsuit against Johnson & Johnson. The lawsuit claims that a bacterial contamination in the infant formula Tylenol was responsible for the death of their infant son in 2010. The medication that their son Markus consumed was manufactured in a Pennsylvania plant. Allegedly, the plant was cited for a number of FDA quality-control violations before it temporarily shut down.
- Toddler Death – In July 2010, two-year-old River Moore allegedly died from taking Children’s Tylenol. River’s parents Katy and Daniel Moore claim that their son began spitting up blood within 30 minutes of taking the drug. The next day, River died of liver failure. The family’s lawyer believes that the Tylenol batch was a super-dose which contained dangerously high levels of acetaminophen. River’s autopsy revealed that his liver enzymes were noted at three times the average level.
- Liver Failure – In 2011, Patricia Burdin suffered acute liver failure after using Tylenol and another medication containing acetaminophen, Lortab. She was admitted to the hospital with fulminant liver failure and required extensive medical treatments. She and her husband sued Johnson & Johnson for medical injuries, financial loss and loss of consortium.
Johnson & Johnson reportedly faced about 250 liver damage lawsuits and multiple lawsuits for other issues such as bacterial contamination and Stevens-Johnson Syndrome, most of which were settled for undisclosed amounts.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.