Public Citizen Sues FDA For Not Yanking Darvon
5 CommentsBy Ed Silverman // June 19th, 2008 // 11:01 am
The consumer group is upset the agency for failing to act on its 2006 petition to withdraw Darvon and other drugs containing propoxyphene, which has done in the UK. The lawsuit claims the FDA is violating the law and putting patients at risk by not requiring a phased withdrawal.
And what is propoxyphene? An addictive painkiller, which Public Citizen maintains “is no more effective than safer alternatives and has been associated with more than 2,000 accidental deaths in America since 1981.” Despite the risks, the group notes it was one of the 25 most prescribed generic drugs last year, with 22 million prescriptions filled in pharmacies. The drug is made by Lilly.
“Top FDA drug officials, including Center for Drug Evaluation and Research Director Dr. Janet Woodcock and Dr. Robert Temple, are well aware that this drug has considerable human toxicity, addiction potential and abuse liability, but very limited therapeutic usefulness. Given this extremely unfavorable ratio of risks to benefits, it is inexcusable that the FDA did not take propoxyphene off the market long ago,” Sid Wolfe of Public Citizen says in a statement.
The UK began a phased withdrawal of the drug three years ago on the recommendation of the UK Committee on Safety of Medicines, which issued a report saying it could not “identify any patient group in whom the risk-benefit (ratio) may be positive.” The withdrawal was completed last year.
A large proportion of the deaths from propoxyphene occurred because most of the drug is converted into a metabolite that is highly toxic to the heart, lasts longer in the body than the original compound and results in cardiac depression, Public Citizen says in its statement.
Adverse cardiac events include an interruption of heart transmission of electrical impulses, slowed heartbeats and a decreased ability of the heart to contract properly. Reports on propoxyphene dosage suggest addiction can occur at less than the maximum recommended daily dose and unequivocally confirm addiction at just twice the recommended daily dose, according to Public Citizen’s statement.
The drug has also been considered inappropriate for the elderly because of effects on the central nervous system - such as sedation and confusion - that can increase the likelihood of falls and fall-related fractures. Studies have shown that popoxyphene use is widespread in emergency rooms, institutionalized populations and retirement communities, the group says.
Vince
The FDA under Dr. Woodcock is very slow to remove any drug. She views the agency as helping to protect drugs of dubious use.An ongoing dispute at this agency threatens public health
Pharma Whore
There is nothing wrong with Darvon if taken properly, in fact we all know that generic formulations usually aren’t as potent as the branded, even though it is bioequivalent. That is an argument for a different day.
That being said, these patients that are taking more than the reccomended dose are just trying to get relief that nornally they would get from a branded product.
The other argument here is that everyone is looking for something less potent than Oxy, here it is, let the placebo effect rule!!!
Lastly, with these 2000 deaths, what other meds were the patients on. I doubt, Darvon alone.
HorusCat
Yep, opiates can kill you. Anyone surprised?
HorusCat
And other narcotics, I should say.
Joseph Walker
I do not know how relevant that my comment may be to anyone, but when I was told by the VA that Darvon would no longer be prescribed because it is considered to be ‘unsafe’ even though in the past it worked very well for me in reducing the level of the chronic neck and head pain which I have had to live with since I was hit by a moving vehicle 13 years ago and somehow survived, I have recently been prescribed morphine which interestingly enough, I was forced to quit after 6 days because I began to have suicidal thoughts. I think it is a crazy world, especially since I am 74 years old and don’t have all that many years left, and regardless what you put in your mouth, it can be a blessing to one person in pain but yet can kill someone else.