FDA Adds Warning to Prescription Acetaminophen Products

In January of 2011, the FDA asked manufacturers of prescription products containing acetaminophen to limit the amount of the drug to 325 mg per pill or tablet.  In addition, labels of all these medications must be updated to warn of the potential risk for liver injury.  This will be a black box warning, the most severe warning that the FDA can require.

The FDA warns that “overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States, many of which result in liver transplant or death.”

This safety communication only affected prescription products, but an updated rule regarding over-the-counter acetaminophen products was released in 2009.  At that time, the FDA published a rule to require specific language to appear on packaging regarding acetaminophen and liver damage.  The new warnings would state that exceeding 4000 mg a day can result in severe liver damage.

For many, these new warnings and labels are too little, too late.  Having been on the market for decades, thousands of individuals have already suffered liver injury because of excess acetaminophen.  If you are one of these people, we urge you to contact us.  Only an experienced attorney can assess your case and give you the immediate answers you need.  Remember that we never see a dime until you do.  You have nothing to lose.  Contact us today.