FDA Requires Warning Label Changes for Painkillers

In June 2005 the FDA advised Pfizer, the maker of Celebrex, and several other drug manufacturers that the package insert, or warning label, for their prescription NSAID painkillers must contain a so-called "black-box warning".  Specifically, the new black-box warnings are intended to alert doctors and patients about the association between these painkillers and the increased risks of heart attacks, ischemic strokes, and gastrointestinal bleeding.  Further, the black-box warnings must describe early symptoms of a serious skin reaction, Stevens-Johnson Syndrome, which has been linked to use of certain NSAID painkillers.

Prescription NSAIDs include Vioxx, which was voluntarily taken off the market by Merck in September 2004 because of the increased heart-attack (MI) and stroke (CVA) risks for Vioxx users .

The FDA initially indicated the need for stronger warning labels for prescription NSAIDs in April 2005 after Pfizer suspended sales of its Bextra painkiller.  The Bextra "recall" ordered by Pfizer was precipitated by a growing number of drug study reports which linked Bextra to cardiovascular side effects and serious skin reactions.  The skin disorders, which are relatively rare but potentially fatal, include Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Erythema Multiforme (EM).

Beyond the prescription NSAIDs, the FDA said warning labels on over-the-counter (OTC) medications containing ingredients such as generic ibuprofen, ketoprofen, or naproxen must also inform patients about the increased risks of cardiovascular side effects, gastrointestinal (GI) bleeding, and serious skin reactions.

For all prescription drug and OTC products in this class, the FDA has said that the mark "NSAID" must be displayed prominently on the respective package insert label in a contrasting color or in bold type.

Read more about Bextra and its serious side effects:

• http://www.druginjurylaw.com/Bextra-information.html

Read more about Toxic Epidermal Necrolysis:

• http://www.drug-injury.com/druginjurycom/2005/06/toxic_epidemal_.html

(Posted by: Tom Lamb)