Study Links Tylenol (Acetaminophen) with Liver Damage

McNeil consumer healthcare, a subsidiary of Johnson and Johnson and manufacturer of Tylenol had been facing quite a troubled time as studies link its pain reliever medicine Tylenol to severe liver damages including liver failure.

The McNeil consumer healthcare has been showered with numerous Tylenol lawsuits off late. The pharmaceutical company is marred with controversy related to Acetaminophen, the main active ingredient of Tylenol.

Many studies have linked acetaminophen to liver damages. Many cases have revealed that patients using Tylenol have suffered from severe liver damages including liver failure due to acetaminophen toxity. The acetaminophen is main active ingredient in the drug and its overdose could lead to severe liver damages. These studies concluded that a large number of people in Americans have suffered acute liver failure due to use of this drug resulting into acetaminophen toxity. They also revealed that the drug side effects have led to hundreds of deaths due to overdosing of acetaminophen, the pain-relieving ingredient in the painkiller Tylenol.

Tylenol is brand name for Acetaminophen. It is a synthetic analgesic and nonopiate in nature. It is a centrally acting drug and is derived from p-aminophenol. 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.

Reports of its link to liver damages have prompted FDA to take prompt actions. It held a joint meeting of the Center for Drug Evaluation and Research, Drug Safety and Risk Management Advisory Committee, the FDA’s Nonprescription Drugs Advisory Committee and the Anesthetic and Life Support Drugs Advisory Committee. The meeting was held to review the risks associated with use of acetaminophen drug such as Tylenol.

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.

The drug is considered safe when taken within restricted dosage, but is said to be dangerous if taken in large dosages for prolonged time. Thus a prompt action by FDA resulted in a ban for infant’s Tylenol as many cases of infant deaths with use of Infant’s Tylenol came into light.

Use of alcohol, while using Tylenol increases the risk of liver damage. Thus a more comprehensive warning labels on the packaging of the drug was asked by FDA. FDA asked doctors to prescribe this drug in lower dosages to avoid risk of liver damages.

This safety alert by FDA has played a good role in boosting morale of plaintiffs involved in different Tylenol lawsuits. This alert was really a setback for the manufacturer of Tylenol, McNeil Consumers Healthcare.

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