OXYGEN
16/06/2005, 14h02
FDA proposes label changes for painkillers
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.
(...)
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.
http://www.usatoday.com/money/industries/health/drugs/2005-06-16-fda_x.htm
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.
(...)
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.
http://www.usatoday.com/money/industries/health/drugs/2005-06-16-fda_x.htm