The US Food and Drug Administration yesterday gave Abbott Laboratories’ antiobesity drug, Meridia (sibutramine), the thumbs up to remain on the market – despite calls by consumer group Public Citizen seeking to have it withdrawn on safety concerns. The agency concluded: “Meridia’s overall risk-benefit profile supports it remaining available as a prescription drug for the treatment of appropriately selected obese patients”
Public Citizen has twice called for the US drug regulator to pull Meridia, and now claims there have been “more than 50 cardiovascular deaths, many in young people” [[04/09/03d]], [[20/03/02c]]. However, a spokesperson for Abbott told PharmaTimes News Online previously that the risk of death in untreated obesity was much greater than amongst the patient population receiving Meridia. And, this decision was supported by Europe’s regulatory body in June 2002, which backed the risk-benefit profile of Reductil, as it is known there [[28/06/02a]].
“Public Citizen’s initial petition was not based on valid scientific analysis, minimized the seriousness of obesity and unnecessarily alarmed and misled patients. Patients must be afforded every possible, effective treatment option when it comes to fighting obesity,” said Robert Kushner, professor of medicine, Northwestern University Feinberg School of Medicine, in a statement from Abbott. Added John Leonard, vice president, Global Medical and Scientific Affairs, Abbott: “This decision is good news for obese patients and their physicians who are considering pharmacotherapy who may have been alarmed by Public Citizen’s campaign of fear, confusion and misinformation.”
In a statement yesterday, Public Citizen said: “Once again, the FDA is siding with a large drug company, much as [it] did several years ago with Merck concerning Vioxx. How many more dangerously flawed decisions will the FDA make before the Congress repeals the Prescription Drug User Fee Act, which brings the agency ever closer to – and makes the agency less vigilant over – the companies that give it almost $200 million a year in funding?” Certainly Dr David Graham, the FDA scientist who called the Vioxx furore “a terrible tragedy” may agree. Last year, in a statement to the US Senate Finance Committee, he named five drugs that he believed posed a risk to human health and should be use-restricted or removed from the market. Meridia was one of those five on the list that also included cholesterol drug Crestor, painkiller Bextra, acne drug Accutane and asthma medicine Serevent [[22/11/04a]].
