FDA Says Pain Meds Must Carry Hefty Warnings

According to a Tuesday announcement from the U.S. Food and Drug Administration, traditional over-the-counter pain medicines like Advil and Tylenol will soon be bearing more serious warnings on their packaging about potential side-effects, such as liver damage and stomach bleeding.

All products carrying the pain reliever acetaminophen ““ also known as paracetamol ““ will be required to display easy-to-read warnings regarding the potential risk of liver damage if too much of the drug is consumed over too long a period of time. 

Though available in numerous generic forms, acetaminophen is known to most consumers as the main ingredient in Tylenol, and is commonly used to reduce fever and relieve headaches as well as other minor pains.

Painkillers containing non-steroidal anti-inflammatory drugs (NSAIDS) will also be required to carry bold warnings about the risk of stomach bleeding. The most prominent members of this group of drugs are aspirin, ibuprofen, and naproxen, found in popular over-the-counter medicines like Advil, Motrin and Aleve.

“We believe the new labeling requirements will add information concerning severe adverse effects of over-the-counter pain relievers and fever reducers that many consumers may not be aware of,” said the FDA’s deputy director for the Division of Non-prescription Regulation Development, Matthew Holman.

The new labeling guidelines will be applicable to all medications containing these drugs, including generic brands and cold medications, in which the drug is often only one of many active ingredients.

The initial proposal for these new rules came about in 2006, though medical experts have been aware of all the possible side effects for years.  Holman described the new guidelines as a precautionary measure to keep patients better informed, especially those who are taking multiple products and may be double-dosing on certain medications.

The new labels will also be required to include information about the risk of liver damage associated with acetaminophen for people who drink three of more alcoholic beverages a day.  The warnings will also advise patients using the blood-thinner warfarin ““ commonly known by its brand name Coumadin ““ to consult with a physician before using products containing acetaminophen.

Holman added that a number of drug manufacturers have already begun modifying their product’s labels to conform to the new standards, which will officially go into effect in April 2010.

Tylenol producer Johnson & Johnson has said that it will soon be revising its products’ packaging to fit the new guidelines.

A spokeswoman for Wyeth, the pharmaceutical giant that produces Advil and Robitussin, commented that the company is fully aware of the FDA’s announcement and would issue a statement soon.

In June, the FDA intends to meet again to discuss what further actions they might take to reduce the risk of liver damage associated with products containing acetaminophen.

According to a number of studies done in recent years, acetaminophen toxicity is by far the most common cause of liver failure in both the U.S. and the U.K., although a metabolite of the drug, rather than the drug itself, is actually responsible for liver and kidney damage.

A 2004 study revealed that acetaminophen overdoses constitute a greater percentage of emergency calls to poison control centers in the U.S. than any other pharmacological substance.

—

On the Net:

• FDA