FDA Considers Stronger Warnings On OTCs

An FDA advisory committee is recommending that over-the-counter painkillers bear stiffer warnings in light of continued episodes of liver and other internal organ damage when consumers take the products in combination with other medications.

Acetaminophen is considered safe when taken as directed, but used in large doses over an extended period of time-which FDA's Non-prescription Drugs Advisory Committee believes can happen when consumers take it in combination with other prescription drugs that also contain acetaminophen-the product has potentially deadly results.

FDA is looking at several types of warnings that could appear on future bottles of OTC packages, and regulators are also considering adding warnings to bottles of ibuprofen and aspirin.

Whether the committee is leaning one way or the other is unknown, but some pharma companies have expressed concern about the possibility of additional labeling. In a brief to the committee, McNeil, a division of Johnson & Johnson and maker of Tylenol (acetaminophen) and Motrin (ibuprofen), states that limiting the use of acetaminophen through labeling could have fatal repercussions.

"If acetaminophen use were restricted, and consequently aspirin and other OTC nonsteroidal anti-inflammatory drugs (NSAID) use increased in the United States, available data suggest that more people would die from aspirin and other NSAID-related gastrointestinal bleeding than those potentially spared from acetaminophen overdose hepatotoxicity," the brief says.

In a prepared statement for the committee, aspirin manufacturer Bayer dismisses McNeil's claims and says it supports the committee's decision to study the issue: "It is Bayer's position that each of the currently approved OTC analgesics used according to package labeling is safe and effective for treatment of mild to moderate pain and reduction of fever."

At press time, a final decision on the recommendation was at least a few weeks away, according to FDA officials. The matter could have significant cost ramifications for those pharma companies.