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 name in over-the-counter pain relief medications. 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 and cold remedies and many prescription pain relievers.
How Does Tylenol Work to Relieve Pain?
The active ingredient in Tylenol, acetaminophen, is the ingredient that blocks the pain. Acetaminophen is able to block pain by preventing the synthesis of prostaglandin. Prostaglandin is the natural substance in the body that is responsible for initiating inflammation.
What Company Manufactures Tylenol?
Tylenol was introduced in 1955 by the McNeil Laboratories pharmaceutical company. The first product was a liquid elixir for children and was only available as a prescription. Tylenol Elixir for Children was widely used in both children and adults. By 1959, McNeil Laboratories was acquired by Johnson & Johnson, the largest pharmaceutical company in the world. Regular-Strength Tylenol tablets for adults were released in 1961, and Tylenol was the number-one painkiller in the United States market.
Today, Tylenol brand medication still sells at a rate of $1 billion per year or more. This does not include generic acetaminophen products or similar products in other countries which are sold under the generic medication name “paracetamol.”
Have There Been Manufacturing Issues with Tylenol?
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.
Has Tylenol Been Recalled?
McNeil Consumer Products and the parent company, Johnson & Johnson, have repeatedly opposed safety warnings, dosage restrictions, and warnings about using Tylenol and alcohol.
Over the years, Tylenol has been recalled a number of times. In 1982, after the criminal tampering issue, Johnson & Johnson recalled 31 million bottles of Tylenol. Between 2009-2011, Tylenol products were recalled 13 times for various reasons.
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.
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.
Has Johnson & Johnson Recalled Other Products?
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
Is Tylenol FDA Approved?
Tylenol was first approved by the FDA in 1950-1951. It was placed on the market in 1955. In 1977, the FDA suggested that a “severe liver damage” warning be placed on acetaminophen products. However, the recommendation would not actually be adopted for 32 years – in 2009.
What Are Possible Side Effects of Tylenol?
Although Tylenol is considered to be safe by most consumers, it may cause side effects and interactions with a number of medications. The majority of interactions, including the most severe adverse event, liver damage, are due to Tylenol’s action on the liver.
What Are Common Side Effects of Tylenol?
Like most medications, Tylenol may cause side effects that are not life-threatening and may go away on their own over time.
Common side effects of Tylenol include:
- Stomach upset
- Stomach pain
- Loss of appetite
- Dark urine
- Clay-colored stools
When taken frequently for headache, if discontinued, “rebound headache” may occur. This often results in more of the medication being taken than may be safe.
Can Tylenol Cause Severe Allergic Reaction?
Although it is rare, a severe allergic reaction may be caused by taking Tylenol.
- Itching of the face, tongue, or throat
- Swelling of the face, tongue, or throat
- Severe dizziness
- Difficulty breathing
Contact your doctor immediately if you have taken Tylenol and experienced any of the above symptoms.
Does Tylenol Interact with Other Drugs?
Due to its toxic effects on the liver, Tylenol may interact negatively with other drugs 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 Isoniazid
- 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.
Is Tylenol Safe to Take When Pregnant or Nursing?
Yes, Tylenol is safe to take when pregnant and/or nursing. Tylenol is the medication of choice to treat pain and fever in pregnant mothers. Tylenol is excreted through breast milk, but it is in such small quantities that it is safe to take Tylenol while nursing.
Is Tylenol Linked 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 a 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.
What Are the Symptoms of Liver Damage?
Liver damage in the beginning stages is often hard to detect.
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.
Is It Possible to Overdose on Tylenol?
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 that 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.
Are There Tylenol Lawsuits Against Johnson & Johnson?
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.
What Are the Claims in the Tylenol Lawsuits?
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 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 that 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.
Are There Tylenol Lawsuit Settlements?
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.
How Do I Find a Tylenol Attorney?
If you or someone you love have experienced liver damage or other severe side effects related to Tylenol, you should seek legal advice. Seeger Weiss, LLP, has an experienced team of attorneys who will offer you a free consultation.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
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