Atlanta Personal Injury Lawyer - acetaminophen

FDA on the Option to Reduce Painkiller Overdoses

Jessica Smagacz — Wed, 01 Jul 2009 00:57:55 GMT

This past Monday, AP reported that the makers of Tylenol, Excedrin and other medications attempted to dissuade regulators from placing new restrictions on painkillers, including the possibility of removing some of them from store shelves.

35 experts were organized by the FDA to attend a two-day meeting in order to discuss ways to prevent overdose with acetaminophen.

Acetaminophen is the pain-relieving, fever-reducing ingredient in Tylenol and some other prescriptions and over-the-counter medications.

Currently, acetaminophen is “the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA.”

Please see our past post: FDA will Discuss Liver Risks with Tylenol & other Painkillers.

FDA asked its experts to consider a range of options:

-Adding a “black box” warning label to the products

-Lowering the drug dosage in some products or

-Pulling certain types of medications off the market

Companies such as the industry group that represents Johnson & Johnson defended the products “saying they pose a relatively small risk to patients.”

“Only 10 percent of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association.”

Although the FDA is not required to follow the advice of its panels, it usually does. This panel vote was supposed to occur earlier today.

According to AP, FDA is making it clear that it “will not play king-maker in the market for over-the-counter medications.”

Originally posted at InjuryBoard by Jessica Smagacz

FDA will Discuss Liver Risks with Tylenol & other Painkillers

Jessica Smagacz — Sat, 27 Jun 2009 02:13:12 GMT

Federal regulators and medical experts will debate next week on how to limit liver injury in patients who take painkillers such as Tylenol, according to CNN.com.

The main issue under the “microscope” is with the ingredient called acetaminophen. This is a drug found in over-the-counter painkillers (such as Excedrin, NyQuil and Theraflu). All of these drugs can cause liver damage, acetaminophen being the most widely used drug in America.

Around 100 people die yearly from accidently overdosing on this common drug, acetaminophen. Apparently, this drug is safe if you take the recommended dosage on the label.

However, FDA does say that “the drug’s prevalence in a variety of pain relievers, fever reducers and cough medicines means patients don’t realize they are taking several drugs that contain the same ingredient, often leading to an overdose of acetaminophen.”

Since 1977 when an agency committee recommended labels for pain relievers to contain a warning about the possibility that they can damage a patient’s liver, FDA has been “struggling with [this] issue.”

Here are the current options that are being discussed:

-reduce recommended dosing levels

-Limit the number of pills or liquid in each drug containing acetaminophen

-and eliminate medicines that combine acetaminophen with other ingredients

Originally posted at InjuryBoard by Jessica Smagacz

Acetaminophen Liver Warnings Recommended by FDA group

Jessica Smagacz — Thu, 28 May 2009 23:55:31 GMT

AP reported that an FDA group released a report this past Wednesday recommending stronger warnings and dose limits on drugs that have the painkiller acetaminophen because of an increased risk of liver injury.

Acetaminophen is available as a generic over-the-counter drug and is also available in prescription drugs. The most well-known over-the-counter drug acetaminophen is found in Johnson & Johnson’s Tylenol.

The working group report said, “There is extensive evidence that hepatotoxicity (liver toxicity) caused by acetaminophen use may result from lack of consumer awareness that acetaminophen can cause severe liver injury.”

The FDA group recommended better public information efforts, stronger labels warning of these liver side effects, and does limitations.

The report also said, “"Consumers may not be aware that acetaminophen is present in many over-the-counter combination products, so they may unknowingly exceed the recommended acetaminophen dose if they take more than one acetaminophen product without knowing that both contain acetaminophen."

Meetings and discussions on these recommendations will be occurring soon.

Originally posted at InjuryBoard by Jessica Smagacz