Makers of Tylenol Nervous Over the Acetaminophen ControversyAugust 17, 2010
Tuesday the Center for Drug Evaluation and Research held a joint meeting with the Drug Safety and Risk Management Advisory Committee, the FDA’s Nonprescription Drugs Advisory Committee and the Anesthetic and Life Support Drugs Advisory Committee to discuss the risks of taking acetaminophen.
Studies have concluded that thousands of Americans have suffered acute liver failure resulting from taking acetaminophen which is the main ingredient in the brand name Tylenol. They have also indicated that the drug has caused hundreds of deaths due to overdosing on the pain killer.
Although it was found that the drug is safe when strictly taken at recommended doses, acetaminophen can be dangerous when taken at too high of levels. Because it is commonly a hidden ingredient in pain relievers, cold medicines and fever reducers the conference was convened to discuss, among other things, the need for the public to be more aware of the risks.
Alcohol only increases the risk of liver damage and the committees are also calling for manufactures of drugs containing acetaminophen to display more comprehensive warning labels on their packaging. The panel is also considering making it mandatory for medical professionals to prescribe lower dosages and making the maximum daily dosage levels for over-the-counter acetaminophen to 3,250 milligrams rather than the limit of 4,000 milligrams prescribed per day.
Trail lawyers, in particular products liability attorneys, are keeping a close watch on the outcome of the meeting. They are not anticipating acetaminophen to face an onslaught of products liability cases; however, they are paying closer attention to what experts are saying about the drugs hazards as a result of the controversy.
The makers of Tylenol are also waiting anxiously for the outcome of this meeting to more accurately gage the concern acetaminophen is causing. Nonetheless, it is currently considered safe at the proper dosages and will still be available to the public over the counter.
ABC News Medical Contributor Dr. Marie Savard said on “Good Morning America” earlier this week, “It’s important to say that they’re not considering taking acetaminophen off the shelves.” He went on to say, “When taken in the proper dosage, this is a safe drug that’s been used for more than a half century. The problem is that people often take more than the maximum dosage and that can cause serious liver damage and sometimes even death.”
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