Personal Injury Law

Tylenol and acetaminophen dangers

Adverse prescription drug reactions are more common than most consumer are aware, and can have serious consequences, including death. Seeking to address these problems, a Food and Drug Administration panel has recommended new limits on acetaminophen, the main ingredient in Tylenol. Acetaminophen is the most commonly prescribed drug in the U.S., and commonly used in other drugs and remedies such as cough and cold medicines.

Acetaminophen overdoses are the main cause of liver failure in the U.S. Accidental acetaminophen overdoses kill about 100 people and send some 56,000 people to emergency rooms annually. The FDA said that while the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines means patients don't realize they are ingesting far more than they should. One study found that 19% of adults in the U.S. take the drug in a given week.

The FDA advisory panel consisting of 37 doctors, pharmacists and researchers voted on the recommendations yesterday after spending two days discussing steps the FDA should take to reduce the number of acetaminophen overdoses.

The FDA panel recommended a series of measures, including banning a number of well known and commonly prescribed prescription pain relief products, such as Vicodin, Ultracet and Percocet. These pain relievers combine acetaminophen with narcotic painkillers.
That recommendation could also affect 240 pending drug applications.

The panel recommended that prescription products containing acetaminophen should include strong warnings about potential liver damage. And they also strongly advised that only one concentration of over-the-counter cold medicines should be available, citing concerns about liver damage in children. That could affect products such as Theraflu and NyQuil.

The panel did not recommend banning over-the-counter cough and cold medicines and other products that combine acetaminophen with other ingredients. The panel cited data showing liver damage occurs most frequently in patients using prescription products.

If accepted by the FDA, which generally follows suggestions of its expert panels, the recommendations could result in major changes in labeling and packaging.

Full post as published by Georgia Injury Lawyer Blog on July 01, 2009 (boomark / email).