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...especially the millions who suffer from inflammatory diseases like arthritis or from chronic back pain, the withdrawal of Vioxx from the market last September and the serious questions raised about the safety of the entire class of COX-2 inhibitor drugs--at last week's Food and Drug Administration (FDA) hearings and in the latest issue of the New England Journal of Medicine--represent yet another setback in the long, frustrating search for relief. "I just loved Vioxx. It was magic," laments rheumatoid arthritis sufferer Lisa Dobbs, 50, of Bethesda, Md. "When they took it off the market...
After three days of contentious discussion, an FDA advisory panel last week recommended that the COX-2 drugs Bextra and Celebrex remain on the market but with certain restrictions. Most panel members favored "black box" warnings on the packages indicating that the drugs raise the risk of heart attack and stroke and are therefore inappropriate for many patients. If the FDA adopts this strategy, it would mean the end of ads like the once ubiquitous "Celebrate!" spots for Celebrex, as black-box drugs may not be advertised directly to consumers. But there was tantalizing news for Rickhoff, Dobbs and other...
...October 15, 2004, the Food and Drug Administration (FDA) issued a Public Health Advisory in which drug manufacturers were required to label antidepressants with a “black box”—the most severe warning outside of an outright ban—describing the risk of suicidal behavior to children and adolescents. This action was promoted by a Columbia University study showing that two to three percent of children taking antidepressants had increased suicidal thoughts and actions, though the FDA has not shown antidepressants to be the precise cause. According to Medco Health Solutions, the last...
Modifying the questioning procedures would have another benefit, too. As the prevalence of HIV among heterosexuals continues to rise, the current questions will soon be inadequate in the pre-filtering process of heterosexual donors, who currently comprise the overwhelming majority of donors. But the FDA seems set on preventing MSM from donating: The proposal that was rejected in 2000 would have allowed MSM to donate only if they had not had sex with men in five years. Lost in the details of the amount of time since a donor’s last sexual activity, the FDA has neglected both...
...Lesbian, Transgender, and Supporter Alliance (BGLTSA), said, “The problem with these rules is that they perpetuate the notion that AIDS is a gay disease and that all of the blood of MSM is tainted.” Granted, it is not the role of the FDA to legitimize or de-legitimize any number of lifestyles (from injecting intravenous drugs to having sex with men to traveling to Africa or Great Britain) by allowing or disallowing such individuals to donate blood. The FDA’s job is, simply, to maintain an adequate, safe supply of blood...