Tylenol is a centrally acting synthetic analgesic. It is non-opiate in nature and is derived from p-aminophenol. It is used for treatment of different types of pain and fever. It is used for treatment of many types of pain such as back pain, muscle pain, joint pain due to arthritis, headache, toothache and any other such pain. It is also used for treatment of cold, chills or fever.
Tylenol comes in different forms. It comes in tablet, caplet, gel tab and codeine. Tylenol is manufactured by McNeil Consumer Healthcare. It was first approved by FDA in 1976 as a pain reliever. Later many of its other derivatives were approved by FDA at different times. Some of its derivatives have been recalled too.
FDA asked for safety label change for Tylenol 8-Hour (650 mg acetaminophen) extended-release tablets in June 2009. It asked the manufacturer to add warning stating that patients having allergy to acetaminophen or other ingredients of this drug, should not use it.
In January 2011, U.S. Food and Drug administration issued a safety alert related to use of Tylenol. It asked the manufacturer to limit the strength of acetaminophen in the drug. It limited the amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit.
It also asked to highlight the potential for severe liver injury and allergic reactions in the Boxed Warning on all drugs containing acetaminophen. This action was aimed at reducing the risk of liver damage due to se of Tylenol medicines.
Acetaminophen is used in both prescription and over-the-counter (OTC) products to reduce pain and fever. It is one of the most common drugs in the United States used to treat pain and fever. Tylenol was also asked to provide warning related to liver injury on its label.
FDA was evaluating the new ways to reduce the risk of liver injury due to use of over the counter acetaminophen drugs such as Tylenol. It asked patients to use Tylenol only on prescription by a doctor and adhere to the dosages as prescribed. It also asked them to consult their doctor in case of developing any unusual side effect. It asked them to carefully read the label before using it.
FDA also asked patients to not use any other acetaminophen drug with Tylenol. It asked them to avoid alcohol, while using this medicine. It also asked patients to report any adverse effect of this drug.
It asked doctors to be careful with Tylenol dosage, while prescribing it. They should also make patients aware about risk of liver damage associated with it and precautions before using it. They should advise patients against alcohol consumption and ask them to report any adverse reaction. They should also report any adverse event.
In June 2011, it asked the manufacturer to recall a lot of Tylenol Extra Strength Caplets. McNeil Consumer Healthcare recalled one product lot of Tylenol Extra Strength Caplets in June 2011. This lot has 225 count bottles, which were distributed in the U.S.
This recall was a result of musty, moldy odor reports. It was linked to a chemical known as 2,4,6-tribromoanisole (TBA). TBA was not considered harmful but was said to generate a nasty odor. It could cause temporary and non-serious gastrointestinal symptoms.
Consumers were asked to stop taking medicine, if they have purchased Tylenol of the batch recalled. They were asked to contact McNeil Consumer Healthcare. Doctors and patients were asked to report any adverse event.
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Author: Jack Taylor Powers Taylor LLP is a boutique litigation firm that represents people injured by unsafe drugs. The attorneys of Powers Taylor founded this firm to focus on client needs. We employ unique and creative litigation strategies to obtain decisive results for our clients.