Dr Curt Furberg, a professor at Wake Forest University School of Medicine, helped conduct the study and said: "Basically, we showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information."
On November 18, 2004, Dr David Graham, head of the FDA's Office of Drug Safety, testified before the Senate Finance committee and listed Bextra as one of five drugs whose safety needs ''to be seriously looked at."
On December 9, 2004, the FDA announced that Bextra would come with a new bolded warning contraindicating its use in patients undergoing coronary artery bypass graft (CABG) surgery.
The FDA knew Bextra was being widely marked for off-label use. Its December 9, Talk Paper, noted that Bextra was "not approved for use in the treatment of postoperative pain of any type;" but added: "however, FDA believes that these new findings should be made available to healthcare professionals and patients, and the bolded warning specifically contraindicates Bextra for treatment of pain immediately following CABG."
The FDA also ordered a black boxed warning on the label stating that patients taking Bextra had reported serious, potentially fatal skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis.
Come to find out, as of November 2004, the FDA had received reports of 87 cases of SJS associated with Bextra. Thirty-six patients required hospitalizations, and 4 people died. Twenty involved patients with a known allergy to sulfa.
Although the other Cox-2 selective inhibitors also showed a risk for SJS, the FDA found reported cases to be greater with Bextra.
SJS is a devastating reaction affecting the skin and mucous membranes, causing severe burning, blistering and sloughing of involved tissue. SJS commonly causes blindness and results in death in 10 to 30 percent of the cases, according to a December 12, 2004 press release by the SJS Foundation.
People also develop SJS as a reaction to other commonly prescribed drugs, including antibiotics, anti-convulsants, and non-steroidal inflammatory drugs (NSAIDS), including over-the-counter drugs such ibuprofen products.
On January 26, 2005, Jean Farrell McCawley, the founder of the SJS Foundation testified before a joint meeting of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
Ms Farell-McCawley told the panel that although SJS was referred to as a rare skin reaction, since 1995, the SJS Foundation had been notified of far more cases of the condition than those recorded by the FDA.
By one estimate, each year, SJS effects three to eight people per million in the US. However, the frequency is thought to be much higher since the FDA acknowledges that only between one and 10% of all adverse drug reactions are reported each year.
"SJS is not as rare as we are led to believe," Ms Farrell McCawley advises. "During the winter months, we learn of 15 new cases a week, and that's only people with Internet access," she says.
It is hard to imagine a more severe adverse drug reaction than SJS. In the April 2005 SJS Newsletter, SrA Tanner Claybaugh published a letter describing what his sister, Mollie, went through after developing SJS as a reaction to children's Advil.
Shortly after taking drug, Mollie developed blisters and rashes all over her body and was hospitalized. "She was put in the Intensive Care Unit (ICU) where there were countless machines keeping her alive," SrA says.
"After about a weeks time," he continued, "she was put in the burn unit as if she had burns from a fire, but the allergic reaction was the cause of her third degree burns."
On November 18, 2004, Dr David Graham, head of the FDA's Office of Drug Safety, testified before the Senate Finance committee and listed Bextra as one of five drugs whose safety needs ''to be seriously looked at."
On December 9, 2004, the FDA announced that Bextra would come with a new bolded warning contraindicating its use in patients undergoing coronary artery bypass graft (CABG) surgery.
The FDA knew Bextra was being widely marked for off-label use. Its December 9, Talk Paper, noted that Bextra was "not approved for use in the treatment of postoperative pain of any type;" but added: "however, FDA believes that these new findings should be made available to healthcare professionals and patients, and the bolded warning specifically contraindicates Bextra for treatment of pain immediately following CABG."
Come to find out, as of November 2004, the FDA had received reports of 87 cases of SJS associated with Bextra. Thirty-six patients required hospitalizations, and 4 people died. Twenty involved patients with a known allergy to sulfa.
Although the other Cox-2 selective inhibitors also showed a risk for SJS, the FDA found reported cases to be greater with Bextra.
SJS is a devastating reaction affecting the skin and mucous membranes, causing severe burning, blistering and sloughing of involved tissue. SJS commonly causes blindness and results in death in 10 to 30 percent of the cases, according to a December 12, 2004 press release by the SJS Foundation.
People also develop SJS as a reaction to other commonly prescribed drugs, including antibiotics, anti-convulsants, and non-steroidal inflammatory drugs (NSAIDS), including over-the-counter drugs such ibuprofen products.
On January 26, 2005, Jean Farrell McCawley, the founder of the SJS Foundation testified before a joint meeting of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
Ms Farell-McCawley told the panel that although SJS was referred to as a rare skin reaction, since 1995, the SJS Foundation had been notified of far more cases of the condition than those recorded by the FDA.
By one estimate, each year, SJS effects three to eight people per million in the US. However, the frequency is thought to be much higher since the FDA acknowledges that only between one and 10% of all adverse drug reactions are reported each year.
"SJS is not as rare as we are led to believe," Ms Farrell McCawley advises. "During the winter months, we learn of 15 new cases a week, and that's only people with Internet access," she says.
It is hard to imagine a more severe adverse drug reaction than SJS. In the April 2005 SJS Newsletter, SrA Tanner Claybaugh published a letter describing what his sister, Mollie, went through after developing SJS as a reaction to children's Advil.
Shortly after taking drug, Mollie developed blisters and rashes all over her body and was hospitalized. "She was put in the Intensive Care Unit (ICU) where there were countless machines keeping her alive," SrA says.
"After about a weeks time," he continued, "she was put in the burn unit as if she had burns from a fire, but the allergic reaction was the cause of her third degree burns."
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