Merck & Co., Inc. Sued by Wechsler Harwood LLP - MRK
December 11, 2004 08:21

by Michael Monheit, Esquire, Monheit Law, PCgoogle_ad_client = "pub-5012235937609631";google_ad_width = 160;google_ad_height = 600;google_ad_format = "160x600_as";google_ad_channel ="4711498459";google_color_border = "6699CC";google_color_bg = "003366";google_color_link... (Read Article)

Bextra, a COX-2 selective non-steroidal anti-inflammatory drug

Bextra (valdecoxib)

Audience: Healthcare professionals and consumers


The FDA announced important new information on side effects associated with the use of Bextra, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) indicated for the treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual pain). A "boxed" warning, strengthening previous warnings about the risk of life-threatening skin reactions, and a new bolded warning contraindicating the use of Bextra in patients undergoing coronary artery bypass graft (CABG) surgery were added to the label.

See Full Story

by Michael Monheit, Esquire, Monheit Law, PCgoogle_ad_client = "pub-5012235937609631";google_ad_width = 160;google_ad_height = 600;google_ad_format = "160x600_as";google_ad_channel ="4711498459";google_color_border = "6699CC";google_color_bg = "003366";google_color_link... (Read Article)

by Michael Monheit, Esquire, Monheit Law, PCgoogle_ad_client = "pub-5012235937609631";google_ad_width = 160;google_ad_height = 600;google_ad_format = "160x600_as";google_ad_channel ="4711498459";google_color_border = "6699CC";google_color_bg = "003366";google_color_link... (Read Article)

See PDF file of the new labeling for Bextra.

PHILADELPHIA -- The Food and Drug Administration approved a new label for Pfizer Inc.'s (PFE) arthritis pain drug Bextra that adds a warning about a risk of heart and blood-clotting problems for patients who recently had coronary artery bypass graft surgery.

The FDA said on its Web site Thursday that it believes the benefits of the drug outweigh the risks when used on the right patients, but warned that those who recently had the bypass surgery or who are allergic to sulfa products shouldn't take Bextra.

Dec. 9 (Bloomberg) -- Pfizer Inc. will warn doctors that its Bextra painkiller, in the same group of drugs as Merck & Co.'s withdrawn Vioxx, is linked to an elevated risk of blood clots, heart attacks and strokes in cardiac-surgery patients.

Bloomberg.com STORY...