Tylenol

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For detailed information about the active ingredient in Tylenol, see Paracetamol, also known as acetaminophen
Tylenol PM (left) and Tylenol (right)
Acetaminophen/Paracetamol (Kekulé Diagram)
Acetaminophen/Paracetamol (Ball and Stick Model)

Tylenol /ˈtlənɒl/ is an 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 is acetaminophen, an analgesic and antipyretic; it is commonly known elsewhere in the world by its international nonproprietary name, paracetamol. Like the words "acetaminophen" and "paracetamol", the brand name "Tylenol" is derived from the chemical name for the compound, N-aceTYL-para-aminophENOL (APAP).[1] The brand name "tylenol" is owned by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson.[2]

History[edit]

James Roth, a U.S. gastroenterologist and principal consultant to McNeil Laboratories, advocated paracetamol as a gastric-friendly alternative to aspirin, which can irritate the stomach when taken without food.[3] In 1953, McNeil Laboratories introduced Algoson, a preparation containing paracetamol together with sodium butabarbital, a sedative. Then 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. Different varieties of Tylenol available today include 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.[4][5]

1982 Chicago Tylenol murders and first recall[edit]

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.[6]

As a result of the crisis, all Tylenol capsules were discontinued, as were capsules of other brand names. Retained by McNeil President Joseph Chiesa, 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, and other manufacturers followed suit. The crisis cost the company more than $100 million, but Tylenol regained 100% of the market share it had before the crisis. The Tylenol murderer was never found, and a $100,000 reward offered by Johnson & Johnson remains unclaimed.

Tylenol remains a top seller, controlling about 35% of the pain killer market in North America, according to a study published in 2003.[7]

2010 Tylenol recall[edit]

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.[8] 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.[9] The full health effects of 2,4,6-tribromoanisole are not known but no serious events have been documented in medical literature.[10] 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.[11]

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.[11] 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.[12]

On Wednesday, May 5, 2010, the Food and Drug Administration (FDA) confirmed[13] 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.[14] 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.

Products[edit]

Tylenol 3, a compound of acetaminophen (300 mg) and Codeine (30 mg)

Tylenol sells products to relieve pain, allergies, and cold- and flu- related symptoms. Allergy and cold products also contain dextromethorphan, antihistamines, and expectorants.[citation needed]

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 (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.[citation needed]

Acetaminophen is also found in other narcotic-based analgesics such as Percocet which additionally contains oxycodone, and Lortab/Vicodin which both additionally contain hydrocodone.[citation needed]

Tylenol PM[edit]

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.

Risk of overdose[edit]

The dangers of acetaminophen, especially in combination with alcohol, have been reported in the medical literature since the 1960s, although they were not always disclosed on the Tylenol labeling and packaging. These dangers were reported in a September 2013 episode of This American Life entitled "Use Only as Directed"[15] and in two investigative articles in ProPublica[16][17]

This American Life reported that "acetaminophen, the active ingredient in Tylenol ... kills the most people [of any over-the-counter drug], according to data from the federal government. Over 150 Americans die each year". This assessment conflicts with assessments in the medical literature, which suggest that the most commonly used alternative to acetaminophen, non-steroidal anti-inflammatory drugs (including naproxen, ibuprofen, and aspirin) cause 3200 deaths and 32,000 hospitalizations each year due to gastric bleeding alone.[18] Other estimates place the number of NSAID-related deaths from gastric bleeding as high as 16,000 per year. [19] The apparent discrepancy may arise because the PBS assessment relied exclusively on reports from poison control centers. Such centers are unlikely to report gastric bleeding episodes as NSAID-related, as such episodes may be caused by factors other than NSAID use, and are associated more closely with chronic use rather than acute overdose.

ProPublica reported that the "FDA has long been aware of studies showing the risks of acetaminophen. So has the maker of Tylenol, McNeil Consumer Healthcare, a division of Johnson & Johnson" and "McNeil, the maker of Tylenol ... has repeatedly opposed safety warnings, dosage restrictions and other measures meant to safeguard users of the drug." This included warnings of liver damage and warnings about using acetaminophen in combination with alcohol. This is especially dangerous because of acetaminophen's narrow safety margin. ProPublica interviewed a man who had liver failure after using Tylenol in the recommended dose and drinking two or three glasses of wine, at a time when the Tylenol label didn't mention any dangers of drinking.

Acetaminophen, including Tylenol, causes three times as many cases of liver failure as all other drugs combined,[20] and is the most common cause of acute liver failure in the United States,[21][22] accounting for 39% of cases.

Advertising[edit]

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.[23] 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".[24]

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.[25]

Use for Lower Back Pain[edit]

The July 23, 2014, online issue of the British medical journal The Lancet reported that, in spite of its common use to manage lower back pain, a recent study of 1,600 patients found that acetaminophen (also known as paracetemol, with the common trade names of Tylenol and Panadol) had no effect beyond that of placebos controlling lower back pain. "Acetaminophen also did not improve patients' level of disability, sleep quality or quality of life." Experts warn that the results of one study may not be enough to change present prescribing patterns, but it should be emphasized that the recommended maximum daily dose is 4,000 milligrams (mg.).[26][27]

See also[edit]

References[edit]

  1. ^ West, Nancy. "History of TYLENOL". Nancy West Communications. Retrieved July 26. 2014. 
  2. ^ Euromonitor International. "Acetaminophen benefits from concerns surrounding safety of analgesics". Market Research World. Retrieved July 26, 2014. 
  3. ^ "Pain relief: from coal tar to paracetamol". Education in Chemistry. Royal Society of Chemistry. July 2005. Retrieved 18 January 2014. 
  4. ^ 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.  - which concludes "the fixed combination of ... caffeine was statistically significantly superior to the combination without caffeine"
  5. ^ 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"
  6. ^ New York Times article: "Tylenol made a hero of Johnson & Johnson : The recall that started them all."
  7. ^ Drug-Induced Hepatotoxicity, William M. Lee, New England Journal of Medicine, July 31, 2003, 349:474-485.
  8. ^ In Recall, a Role Model Stumbles, Natasha Singer, New York Times, 17 January 2010
  9. ^ Tylenol recall expands, WebMD, accessed 1-17-2010.
  10. ^ McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products In The Americas, UAE, and Fiji
  11. ^ a b FACTBOX-Johnson & Johnson's recent product recalls
  12. ^ Grime, dust, bacteria found at J&J plant: FDA (Reuters, May 4, 2010
  13. ^ Bacteria Identified in Recall, CNN, First Published: May 5, 2010
  14. ^ Kavilanz, Parija (6 May 2010). "Bacteria identified in Tylenol recall". CNN. Retrieved 21 July 2010. 
  15. ^ "Use Only as Directed". This American Life. Episode 505. 20 September 2013. Public Radio International. WBEZ. http://www.thisamericanlife.org/radio-archives/episode/505/use-only-as-directed. Retrieved 24 September 2013.
  16. ^ Gerth, Jeff; T. Christian Miller (20 September 2013). "Use Only as Directed". ProPublica. Retrieved 24 September 2013. 
  17. ^ Miller, T. Christian; Jeff Gerth (20 September 2013). "Dose of Confusion". ProPublica. Retrieved 24 September 2013. 
  18. ^ Tarone RE, Blot WJ, McLaughlin JK (2004). "Nonselective nonaspirin nonsteroidal anti-inflammatory drugs and gastrointestinal bleeding: relative and absolute risk estimates from recent epidemiologic studies". Am J Ther 11 (1): 17–25. PMID 14704592. 
  19. ^ Tarone RE, Blot WJ, McLaughlin JK (2004). "Nonselective nonaspirin nonsteroidal anti-inflammatory drugs and gastrointestinal bleeding: relative and absolute risk estimates from recent epidemiologic studies". Am J Ther 11 (1): 17–25. PMID 14704592. 
  20. ^ Warnings Sought for Popular Painkiller by Sheryl Gay Stolberg, New York Times, Published: September 20, 2002
  21. ^ Bushel PR, Heinloth AN, Li J, et al. (November 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. 
  22. ^ Awareness: Too Much Acetaminophen? Few Seem to Know, By Nicholas Bakalar, New York Times, February 27, 2007
  23. ^ Midori's Tylenol Commercial
  24. ^ Tylenol Rapid Release Commercial
  25. ^ Tylenol Commercial (1986)
  26. ^ "Acetaminophen May Not Help Against Back Pain, Study Contends" Web MD [1]
  27. ^ "Acetaminophen may do little for acute back pain." Harvard Health blog. [2]

External links[edit]