FDA Advisory on SibutramineWednesday, September 15, 2010
This morning, I will be addressing an Advisory Committee appointed by the US Food and Drug Administration (FDA) to evaluate the risk/benefit of sibutramine, an anti-obesity drug that has been on the market for over a decade.
The FDA advisory was prompted by the results of the Sibutramine Cardiovascular OUTcomes (SCOUT) study, published last week in the New England Journal of Medicine.
As blogged previously, the SCOUT study showed a 16% increase in non-fatal heart attacks and stroke on sibutramine compared to placebo.
As also blogged before, the problem with simply extrapolating these findings to patients who would normally be prescribed sibutramine is confounded by the fact that almost all participants in the SCOUT trial had known contraindications to the use of sibutramine and were continued on sibutramine irrespective of whether or not they actually lost weight (something very unlikely to ever happen in clinical practice).
It will be up to the Advisory Committee to decide whether or not the benefit/risk ratio for sibutramine remains favourable in the “on-label” population, i.e. in individuals who do not have a history of cardiovascular disease, have well-controlled blood pressure, and who achieve at least 5% weight loss within the first months of treatment.
This should be an easy decision, as sibutramine is not only an effective anti-obesity drug for a substantial number of patients, but also, despite all the noise to the contrary, has a surprisingly benign side effect profile when used in accordance with the current label.
On the other hand, I would imagine that the Advisors will be most interested in how Abbott (the makers of sibutramine) will help ensure that this drug does not get used by people who really shouldn’t be on it in the first place (i.e. people with pre-existing history of cardiovascular disease, those who do not lose weight and/or experience untoward increases in blood pressure or heart rate).
As I have pointed out before, no effective anti-obesity drug is likely to ever be safe enough to be used by the wrong patients. Indeed, if US doctors cannot be trusted to adequately consider indications and contraindications in their prescriptions of medication, I can think of numerous other drugs that should probably be pulled from the market because they may cause problems when prescribed to the wrong patients without adequate monitoring of side effects.
As heralded by the remarkable media interest in this event, the vote of the Advisory Committee, although not binding for the FDA, will likely have an important signal effect that may well determine the fate of all anti-obesity medications in the foreseeable future.
Anyone interested in the future of pharmacotherapy for obesity should likely be paying close attention to today’s hearing.
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Disclosure: I have received consulting and speaking honoraria from Abbott Laboratories, the makers of sibutramine.
James WP, Caterson ID, Coutinho W, Finer N, Van Gaal LF, Maggioni AP, Torp-Pedersen C, Sharma AM, Shepherd GM, Rode RA, Renz CL, & SCOUT Investigators (2010). Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. The New England journal of medicine, 363 (10), 905-17 PMID: 20818901
Wednesday, September 15, 2010
The use of ANY medication in those who it is contraindicated would likely result in adverse effects. Hence the addition of the contraindication in the first place.
Morever, I’m not sure how it is reasonable to make Abbott responsible for making sure it only lands in the hands of the right patients. Physicians write the prescriptions and being aware of the uses and potential complications assocaited with each medication is their responsibility.
And I’d like to add the point that it is also important for patients to take some responsibility in their own care. It is on their shoulders to read the labels and ask questions when appropriate. I can’t even begin to tell you how many people I’ve met who can’t tell me the names of their medications let alone what any of them do or their potential side effects.
In the end, I think that using the right medications with the right patients is the key. I also think that it is the responsibility of the physician and the patient to make sure the drug is both safe and effective for them.