Before you read any media reports, read Derek's balanced analysis of both the FDA and Sanofi's documents on the risks and benefits on Accomplia. As usual, he tees up the issue with insight and objectivity:
The incidence of suicidality – specifically suicidal ideation – was higher for 20 mg
rimonabant compared to placebo. Similarly, the incidence of psychiatric adverse events,
neurological adverse events and seizures were consistently higher for 20 mg rimonabant compared to placebo. . ."
They're also concerned about other neurological side effects, and seizures as well. The seizure data don't look nearly as worrisome, except in the obese diabetic patients, for whom everything seems to be amplified. And all of this happens at the 20-mg dose, not at the 5 (which doesn't do much for weight, either, as noted above). And for those who are wondering, yes, on my first pass through the data, I find these statistics much more convincing than I did the ones on the Avandia (rosiglitazone) association with cardiac events.
I had my worries about rimonabant a long time ago, but not for any specific reason. It's just that I used to work on central nervous system drugs, and you have to be ready for anything. Any new CNS mechanism, I figured, might well set off some things that no one was expecting, given how little we understand about that area."
Another important element that I think favors approval: Sanofi-Aventis is proposing labeling and prescribing limits to take into account the increased risk of a variety of pyschological side effects ranging from anxiety to suicidal thoughts (primarily among schizophrenics and others with a history of mental illness). Importantly, people in Accomplia trials had to go off antidepressants while on the drug so the label and risk management plan will limit use of the drug to people who are either on antidepressants or who are depressed. In Europe, compliance with such limits is around 95 percent.
Watch the fearmongers rise up and scream that no one should be allowed to have access to a drug that demonstrates the ability to reduce weight and glucose levels safely in a specific population. If Accomplia is NOT approved with the RISKMAP in place, with a pledge for post market studies and surveillance, no DTC ads for at least half a year, then what good is PDUFA?
Accomplia is a litmus test for the backbone of the agency and the political strength of the fearmongers.
The incidence of suicidality – specifically suicidal ideation – was higher for 20 mg
rimonabant compared to placebo. Similarly, the incidence of psychiatric adverse events,
neurological adverse events and seizures were consistently higher for 20 mg rimonabant compared to placebo. . ."
They're also concerned about other neurological side effects, and seizures as well. The seizure data don't look nearly as worrisome, except in the obese diabetic patients, for whom everything seems to be amplified. And all of this happens at the 20-mg dose, not at the 5 (which doesn't do much for weight, either, as noted above). And for those who are wondering, yes, on my first pass through the data, I find these statistics much more convincing than I did the ones on the Avandia (rosiglitazone) association with cardiac events.
I had my worries about rimonabant a long time ago, but not for any specific reason. It's just that I used to work on central nervous system drugs, and you have to be ready for anything. Any new CNS mechanism, I figured, might well set off some things that no one was expecting, given how little we understand about that area."
Another important element that I think favors approval: Sanofi-Aventis is proposing labeling and prescribing limits to take into account the increased risk of a variety of pyschological side effects ranging from anxiety to suicidal thoughts (primarily among schizophrenics and others with a history of mental illness). Importantly, people in Accomplia trials had to go off antidepressants while on the drug so the label and risk management plan will limit use of the drug to people who are either on antidepressants or who are depressed. In Europe, compliance with such limits is around 95 percent.
Watch the fearmongers rise up and scream that no one should be allowed to have access to a drug that demonstrates the ability to reduce weight and glucose levels safely in a specific population. If Accomplia is NOT approved with the RISKMAP in place, with a pledge for post market studies and surveillance, no DTC ads for at least half a year, then what good is PDUFA?
Accomplia is a litmus test for the backbone of the agency and the political strength of the fearmongers.
