Tylenol (brand)
Tylenol (/[invalid input: 'icon']ˈtaɪlənɒl/) is a North American brand of drugs advertised for reducing pain, reducing fever, and relieving the symptoms of allergies, cold, cough, and flu. The active ingredient of its original, flagship product, acetaminophen (called paracetamol elsewhere in the world), is marketed as an analgesic and antipyretic. Like the words "acetaminophen" and "paracetamol", the brand name is derived from the chemical name for the compound, N-acetyl-para-aminophenol (APAP).[1] The brand is owned by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson.[2]
History
James Roth, a U.S. gastroenterologist, advocated paracetamol as a gastric-friendly alternative to aspirin, which can irritate the stomach when taken without food. Roth was also principal consultant to McNeil Laboratories. In 1953, McNeil Laboratories introduced Algoson, a preparation containing paracetamol together with sodium butabarbital, a sedative. In 1955, McNeil Laboratories introduced Tylenol Elixir for children, which contained paracetamol as its sole active ingredient. It was originally marketed mainly towards children, but soon came to dominate the North American pain-killer market. There are a number of different varieties of Tylenol available today including extra-strength (with 500 milligrams of paracetamol), children's doses, longer-lasting, and sleep aiding (in combination with diphenhydramine). In 2005, Tylenol Ultra was introduced in Canada, with 500 mg of paracetamol and 65 mg of caffeine; caffeine has vasoconstricting effects, for which there is some disputed evidence for additional effectiveness.[3][4] The patent on paracetamol has long expired, and the continued success of Tylenol brand preparations are largely due to marketing,[citation needed] the backing and reputation of Johnson & Johnson, and new patented delivery mechanisms such as quick-release and extended-release forms of the medication.[citation needed]
1982 Chicago Tylenol murders and first recall
On September 29, 1982, a "Tylenol scare" began when the first of seven individuals died in metropolitan Chicago, after ingesting Extra Strength Tylenol that had been deliberately contaminated with cyanide. Within a week, the company pulled 31 million bottles of tablets back from retailers, making it one of the first major recalls in American history.[5]
As a result of the crisis, all Tylenol capsules were discontinued, as were capsules of other brand names. New product consultant Martin Calle and management strategist Calle & Company conceived the world's first tamper-proof gelatin-enrobed capsule called "Tylenol Gelcaps" which proved to resuscitate the 92% of capsule-segment sales lost to the recall. The tamper-proof, triple-sealed safety containers were swiftly placed on the shelves of retailers 10 weeks after the withdrawal. Other manufacturers followed suit. The crisis cost the company more than $100 million. Tylenol regained 100% of the market share it had before the crisis. Seven people died. The Tylenol murderer was never found. A $100,000 reward offered by Johnson & Johnson still remains unclaimed.
Tylenol remains a top seller, controlling about 35% of the pain killer market in North America.[6]
2010 Tylenol recall
On January 15, 2010, 20 months after first receiving consumer complaints, Johnson & Johnson announced a voluntary recall of several hundred batches of popular medicines, including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol.[7] The recall was due to complaints of a musty smell which is suspected to be due to contamination of the packaging with the chemical 2,4,6-tribromoanisole.[8] The full health effects of 2,4,6-tribromoanisole are not known but no serious events have been documented in the medical literature.[9] The recall came 20 months after McNeil first began investigating consumer complaints about moldy-smelling bottles of Tylenol Arthritis Relief caplets, according to the United States Food and Drug Administration. The recall included 53 million bottles of over-the-counter products including Tylenol, Motrin and Rolaids, Benadryl and St. Joseph's Aspirin, involving lots in the Americas, the United Arab Emirates and Fiji.[10]
On April 30, 2010, another recall was issued for 40 products including liquid infant and children's pain relievers, Tylenol, and Motrin and allergy medications Zyrtec and Benadryl.[10] A Food and Drug Administration report said its inspectors found thick dust and grime covering certain equipment, a hole in the ceiling and duct tape-covered pipes at the Fort Washington, Pennsylvania, facility that made 40 products recalled.[11]
On Wednesday, May 5, 2010, the Food and Drug Administration (FDA) confirmed[12] that the bacteria found at the Johnson & Johnson plant that made the recalled Children's Tylenol was Burkholderia cepacia, a bacteria often resistant to common antibiotics.[13] The CDC has stated that Burkholderia cepacia is not likely to cause health problems for those with healthy immune systems but those with weaker ones and those with chronic lung diseases, such as cystic fibrosis, could be more susceptible to infection.
Dangers
Acetaminophen causes three times as many cases of liver failure as all other drugs combined,[14] and is the most common cause of acute liver failure in the United States,[15][16] accounting for 39% of cases. While this generally occurs through overdosing,[6] the window of toxicity can increase at lower than toxic doses when acetaminophen is combined with alcohol, especially in heavier drinkers, or those with compromised liver function as a result of alcohol use.[17][18]
Acetaminophen is metabolized in the liver, resulting in a by-product, N-acetyl-p-benzoquinone imine (NAPQI), that can damage liver cells, but is typically converted into a harmless substance by an antioxidant glutathione. However, large doses of acetaminophen overwhelms the body's supply of glutathione, resulting in destruction of the liver cells.[19]
People who have the highest risk for Acetaminophen related kidney failure include: heavy drinkers (three or more drinks per day), elderly men, and persons with pre-existing liver or kidney damage.[20]
A study published by the Journal of the American Medical Association in 2006 suggests problems even in healthy people taking the pain reliever as directed.[21] Healthy adults taking maximum doses of Tylenol for two weeks had abnormal liver test results. Dr. Neil Kaplowitz of the University of Southern California, co-author of the study, said, "I would urge the public not to exceed four grams a day. This is a drug that has a rather narrow safety window..."[22]
According to a preliminary study mixing acetaminophen and caffeine may cause liver damage, especially in heavy caffeine drinkers. Researchers discovered that caffeine can triple the amount of, N-acetyl-p-benzoquinone imine (NAPQI), the dangerous by product which destroys liver cells.[23] This reaction can also be caused by large doses of painkillers that combine caffeine and acetaminophen (e.g., Anacin, Excedrin & Midol). These products are often used to treat migraines and menstrual discomfort. Dr. Sid Nelson, a professor of medicinal chemistry at the University of Washington said, "Caffeine can interact with an enzyme that can form a toxic metabolite of acetaminophen in such a way that it increases the formation of that toxic metabolite".[24]
Symptoms from an overdose of acetaminophen typically appear after 24 hours, or in some cases up to 48 hours, however immediate treatment prior to the onset of symptoms can greatly improve the outcome. The antidote to acetaminophen overdose, N-acetylcysteine (NAC), is most effective when taken within eight-hours of an overdose.[25] Due to the delayed symptoms and the importance of immediate treatment, overdoses of acetaminophen kill about 12% of those who seek treatment.[17] Typical symptoms range from nausea and malaise to extreme upper abdominal pain in the region of the liver.
Tylenol is only one among many popular medications containing acetaminophen, but few users realize that it is contained in hundreds of other pain relievers and cold remedies, and that combined usage has a cumulative effect. Fifteen percent of accidental overdoses involve the simultaneous use of more than one product containing acetaminophen.[26] Products from common brands include acetaminophen: Excedrin, Midol, Theraflu, Alka-Seltzer and NyQuil, as well as prescription narcotics such as Vicodin and Percocet. Following the recommended dosages for each, but in combination can far exceed safe limits for acetaminophen intake.[27] The manufacturers of Tylenol recommend, "You should not take two or more products that contain acetaminophen at the same time."[28]
The effectiveness of acetaminophen (paracetamol) alone as an antipyretic (fever-reducing drug[29]) in children is uncertain with some evidence showing it is no better than physical methods.[30] Therapies involving the combination of acetaminophen and aspirin, or alternating doses of acetaminophen and ibuprofen have shown somewhat greater antipyretic effect than acetaminophen alone.[31]
Link with Childhood Asthma Dr. John McBride reported in the journal, Pediatrics, http://pediatrics.aappublications.org/content/early/2011/11/04/peds.2011-1106.full.pdf+html?sid=292aac87-0b02-4f3f-86c7-99a0bccb2314 on 1st November 2011, that Acetaminophen, marketed as Tylenol in the USA and in the UK as Paracetamol, may worsen asthma symptoms in both adults and children. He reviewed recent studies on the medication, which suggest that the drug may exacerbate asthma in children and adults who already have the condition and could even spark new cases.
One of studies McBride cites looked at 520,000 children from 122 centers in 54 countries. In a report on that data published in The Lancet in 2008, researchers found that the risk of developing asthma jumped by 60 percent in 6- to 7-year-olds who had taken acetaminophen at least once a year but less than once a month. In children who took the medication at least once a month, the risk more than tripled.
A second report using the same data was published in the American Journal of Respiratory and Critial Care Medicine in 2011. That report found that the risk of developing asthma jumped by 40 percent in 13- to 14-year olds who had taken acetaminophen at least once a year but less than once a month. In children of the same age group who took the medication at least once a month, the risk more than doubled. Other studies found acetaminophen associated with an increased risk of asthma in adults.
Products
Tylenol sells products to relieve pain, allergies, and cold- and flu- related symptoms. Allergy and cold products also contain dextromethorphan, antihistamines, and expectorants.
Tylenol is also sold as a class of stronger pain relievers containing codeine, known as co-codamols: Tylenol 1 contains 325 mg acetaminophen and 8 mg codeine; Tylenol 2 contains 300 mg/15 mg, Tylenol 3 (300 mg/30 mg), and Tylenol 4 (300 mg/60 mg). In Canada, Tylenol 1, 2 and 3 all include 15 mg caffeine, in addition to the above ingredients; furthermore, Tylenol 1 is sold in Canada without a prescription, while all forms of Tylenol with codeine require a prescription in the US.
Acetaminophen is also found in other narcotic-based analgesics such as Percocet which additionally contains oxycodone, and Lortab/Vicodin which both additionally contain hydrocodone.
Tylenol PM
Tylenol PM is the trademark for a mixture of acetaminophen (paracetamol) and diphenhydramine, distributed by Johnson & Johnson. It is marketed as a combined analgesic and sedative. It is listed as non-habit forming. Diphenhydramine is an anticholinergic used as the active ingredient in Benadryl, for its antihistamine properties, and Benylin, which is used in cough and cold therapy as an antitussive (anti-cough) medication. As its name implies, the product is a sleep aid medication.
Advertisements
Tylenol has many different advertisement approaches. One of these advertisement campaigns focuses on “getting you back to normal”, whereas the other commercials focus on Tylenol’s current slogan, “Feel better, Tylenol”. In the “Feel better, Tylenol” commercials, Tylenol places emphasis on the importance of sleep; various people are seen sleeping in this commercial while a voiceover describes how sleep can help repair and heal the human body during times of aches and pains.[32] In the “getting you back to normal” commercial, Tylenol places more emphasis on helping its consumers get back to their daily routines; many different people are shown first experiencing headaches and other sorts of body pain, where a voiceover then states that Tylenol Rapid Release can help rid aches and pains; the various people are then showed enjoying their everyday lives, and are seen as “back to normal”.[33] In an older commercial from 1986, Tylenol emphasized that it is the drug that American hospitals trust the most. In this ad, Susan Sullivan told the consumer that Tylenol was a drug that could be trusted by Americans since many doctors also trusted it; she went on to state that doctors prescribed Tylenol four times more often than the other leading pain relieving drugs combined.[34]
See also
References
- ^ History of TYLENOL – McNeil Consumer Healthcare Company.
- ^ Euromonitor International. Acetaminophen benefits from concerns surrounding safety of analgesics
- ^ Diener H, Pfaffenrath V, Pageler L, Peil H, Aicher B (2005). "The fixed combination of acetylsalicylic acid, paracetamol and caffeine is more effective than single substances and dual combination for the treatment of headache: a multicentre, randomized, double-blind, single-dose, placebo-controlled parallel group study". Cephalalgia. 25 (10): 776–87. doi:10.1111/j.1468-2982.2005.00948.x. PMID 16162254.
{{cite journal}}: CS1 maint: multiple names: authors list (link) - which concludes "the fixed combination of ... caffeine was statistically significantly superior to the combination without caffeine" - ^ Loder E (2005). "Fixed drug combinations for the acute treatment of migraine : place in therapy". CNS Drugs. 19 (9): 769–84. doi:10.2165/00023210-200519090-00004. PMID 16142992. - which notes that "benefits assumed for ... caffeine ... are not clearly confirmed in these trials"
- ^ New York Times article: "Tylenol made a hero of Johnson & Johnson : The recall that started them all."
- ^ a b Drug-Induced Hepatotoxicity, William M. Lee, New England Journal of Medicine, July 31, 2003, 349:474-485.
- ^ In Recall, a Role Model Stumbles, Natasha Singer, New York Times, 17 January 2010
- ^ Tylenol recall expands, WebMD, accessed 1-17-2010.
- ^ McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products In The Americas, UAE, and Fiji
- ^ a b FACTBOX-Johnson & Johnson's recent product recalls
- ^ Grime, dust, bacteria found at J&J plant: FDA (Reuters, May 4, 2010
- ^ Bacteria Identified in Recall
- ^ Kavilanz, Parija (6 May 2010). "Bacteria identified in Tylenol recall". CNN. Retrieved 21 July 2010.
- ^ Warnings Sought for Popular Painkiller By Sheryl Gay Stolberg, New York Times, Published: September 20, 2002
- ^ Bushel PR, Heinloth AN, Li J; et al. (2007). "Blood gene expression signatures predict exposure levels". Proc. Natl. Acad. Sci. U.S.A. 104 (46): 18211–6. doi:10.1073/pnas.0706987104. PMC 2084322. PMID 17984051.
{{cite journal}}: Explicit use of et al. in:|author=(help); Unknown parameter|month=ignored (help)CS1 maint: multiple names: authors list (link) - ^ Awareness: Too Much Acetaminophen? Few Seem to Know, By Nicholas Bakalar, New York Times, February 27, 2007
- ^ a b Tylenol Toxicity, Medicinenet.com]
- ^ Tylenol Overdoses Linked To Acute Failure of Liver, by Denise Grady, The New York Times, October 16, 1997,
- ^ What you don't know about Tylenol can kill you, By Dr. W. Gifford Jones, Canadian Free Press, September 8, 2003
- ^ Lee M (1998). "Acute Renal Failure in an Alcoholic Taking Acetaminophen". Journal of the American Board of Family Practice. 11 (5): 410–13. unknown.
- ^ High doses of Tylenol are linked to liver damage, by Denise Gellene, Los Angeles Times, July 5, 2006
- ^ High Tylenol Doses Linked to Liver Woes By Carla K. Johnson, Washington Post (AP) Tuesday, July 4, 2006
- ^ Mixing Tylenol With Caffeine may Increase the Risk of Liver Damage, Study Finds, By Tina Benitez, September 27, 2007, Fox News
- ^ Caffeine Plus Acetaminophen Toxic for Some, By Steven Reinberg, Washington Post, September 26, 2007
- ^ Acetaminophen (Tylenol) Poisoning WebMD.com
- ^ Aches, Pains and Warning Labels By William M. Lee, New York Times, March 17, 2004]
- ^ Poisonings From a Popular Pain Reliever Are Rising, By Deborah Franklin, New York Times, November 29, 2005
- ^ Tylenol.com warning at manufacturer website.
- ^ "Definition of antipyretic". Merriam-Webster Online Dictionary. Retrieved 2007-12-19.
- ^ Meremikwu M, Oyo-Ita A (2002). Meremikwu, Martin M (ed.). "Paracetamol for treating fever in children". Cochrane Database Syst Rev (2): CD003676. doi:10.1002/14651858.CD003676. PMID 12076499.
Trial evidence that paracetamol has a superior antipyretic effect than placebo is inconclusive.
- ^ E. Michael Sarrell, MD; Eliahu Wielunsky, MD; Herman Avner Cohen, MD (2006). "Antipyretic treatment in young children with fever: acetaminophen, ibuprofen, or both alternating in a randomized, double-blind study". Archives of Pediatrics & Adolescent Medicine. 160 (2): 197–202. doi:10.1001/archpedi.160.2.197. PMID 16461878. Retrieved 2010-09-25.
{{cite journal}}: CS1 maint: multiple names: authors list (link) - ^ Midori's Tylenol Commercial
- ^ Tylenol Rapid Release Commercial
- ^ Tylenol Commercial (1986)