FDA proposes label changes for NSAIDs (popular pain killers)

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FDA proposes label changes for NSAIDs

 

 

 

Source >

http://www.usatoday.com/money/industries/health/drugs/2005-06-16-fda_x.htm?csp=2\

6 & RM_Exclude=Juno

 

Bloomberg News

 

The Food and Drug Administration sent proposed label

changes to Pfizer, the maker of Celebrex, and other

painkiller manufacturers regarding heart and bleeding

risks associated with their drugs.

The new warnings were delivered to all makers of

prescription and over-the-counter non-steroidal

anti-inflammatory drugs (NSAIDs), the FDA said on its

Web site. NSAIDs include Merck's Vioxx, pulled off the

market in September because of heart-attack risk, and

generic ibuprofen, an over-the-counter painkiller.

 

The FDA called for the stronger cautions in April

after Pfizer suspended sales of its Bextra painkiller,

which was linked to cardiovascular and skin disorders.

The agency will monitor how companies phrase and

display the advisories, said Kathleen Quinn, an FDA

spokeswoman.

 

" This is an ongoing process, and we will be in contact

with the companies, " she said in a telephone interview

Wednesday.

 

Prescription NSAIDs such as Celebrex will require a

" black box " warning, the FDA's most severe, regarding

the increased risk of heart disease and

gastrointestinal bleeding. The labels must also

include a description of the early symptoms of

Stevens-Johnson Syndrome, a rare skin condition that

painkiller use can trigger, the FDA said.

 

Labels on over-the-counter medications containing

ingredients such as generic ibuprofen, ketoprofen or

naproxen must also inform consumers about increased

heart and bleeding risks, as well as possible allergic

reactions, the FDA said.

 

" NSAID " must be displayed prominently on the label in

color contrast or bold type, the agency said.

 

" We've received the letter, we're reviewing it, and

we'll be working closely with the FDA to finalize the

label, " Pfizer spokeswoman Mariann Caprino said in a

telephone interview.

 

Celebrex and Bextra generated $4.6 billion in

worldwide sales for New York-based Pfizer in 2004,

while Merck's Vioxx had $2.5 billion a year in sales

before the recall.

 

Shares of Pfizer, which rose 4 cents to $28.43 in New

York Stock Exchange composite trading, have declined

19% in the past year. Merck, based in Whitehouse

Station, N.J., climbed 12 cents to $31.90. Its shares

have lost one-third of their value in the past year.