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.
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
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.
Side Effects and Drug Interactions of Tylenol
Though Tylenol is considered to be safe by most consumers, like most medications, Tylenol does have side effects and interacts 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.
There are few mild side effects of Tylenol and generally only include those most common to all medications such as nausea and headaches (especially headaches that occur after using the product for a long period of time, known as “rebound headache”). Some people may also be allergic to the medication, though this is rare.
Due to its toxic effects on the liver, Tylenol has drug interactions such as:
- Over-the-counter cough and cold medication containing acetaminophen – overdose
- Prescription pain relievers that contain acetaminophen such as Vicodin, Darvocet, Norco, Percocet, Tylenol with Codeine, Fioricet – overdose
- Anticonvulsants and other medications that affect the liver such as Dolobid (diflunisal) and Isoniazide – toxicity
- 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. If you consume alcohol, you should be honest with your doctor about your use of alcohol and ask about whether you can use Tylenol at all.
Tylenol and The Liver
Tylenol, the brand name of acetaminophen can be very damaging to the liver. The liver is responsible for manufacturing of nutrients from food, production of bile to digest food, and cleaning the blood from toxins including alcohol and other medications.
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.
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.
Many Tylenol users are pursuing lawsuits against McNeil Consumer Products and the parent company, Johnson & Johnson for liver damage and liver failure caused by the drug. Plaintiffs allege that companies failed to adequately warn users of the potentially fatal liver damage that Tylenol can cause. Additionally, the company is accused of recommending dangerously high maximum daily doses of Tylenol products such as Extra-Strength Tylenol.
In 2013, all federal Tylenol liver damage cases were consolidated into multidistrict litigation (MDL) the US District Court for the Eastern District of Pennsylvania under the supervision of Judge Lawrence F. Stegal. This court is near Johnson & Johnson headquarters and many of the first claims were filed in this district.
A private lawsuit by the Cherry family claims that Concentrated Tylenol Infant Drops were responsible for the death of their two-month old son in 2010. Testing after the baby’s death showed that the Tylenol he ingested contained harmful bacteria. The 2010 recall related to bacterial contamination took place two weeks after the infant died.
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.
Over 20 cases are also pending in the State of New Jersey and allege serious injury or death as a result of acetaminophen use. These claims are just the first wave of expected lawsuits regarding Tylenol labeling and liver damage.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.