BelPhen Controversy

BelPhen Controversy

Belphen - Lorcaserin and Phentermine Combination

Belphen is not a marketed product yet but it is the name that has been given to the combination of lorcaserin (Belviq) and phentermine, two drugs which aid weight loss in obese patients, but, only one of them is approved by the Food and Drug Administration (FDA) for the market. Currently, in combination, these drugs can be prescribed off-label by physicians for their obese patients and there are mixed feelings on the matter at the moment about how doctors will react if and when patients start asking for it. Currently, phentermine is available on a restricted basis, although it is rare that it is prescribed. Obviously a play on the name of controversial drug, Fen-Phen, a combination of the drugs fenfluramine and phentermine, that were banned in the late nineties for causing damage to the lungs and heart valves of obese patients, Belphen is another attempt at using the controversial phentermine for patients, in combination, in order to achieve successful weight loss results. In a climate that is arid in terms of really successful appetite suppressants and weight loss drugs for those who are dangerously overweight, it might be the case that we are willing to take too much risk for the desired outcomes in the fight against obesity, yet again.

Years ago, the Fen-Phen drug combination was withdrawn by the FDA for use in obese patients due to a number of fatalities, illnesses and subsequently, serious pay outs in terms of legal damages. Now, the FDA approved drug, Belviq (Lorcaserin), is subject to being prescribed off-label in combination with phentermine; one of the two drugs that make up Fen-Phen. Phentermine, this correspondent drug, is thought to be in no way responsible for any of the health risks that are attributed to fenfluramine so, it has since been thought that the use of phentermine in the short term is fine but many practitioners are dubious. The big question is whether or not we are going down the same path with pairing two products that have not been FDA approved or assessed in long term studies, in combination. Furthermore, is it fair that the full responsibility is left with the physician in terms of prescribing this drug for desperate patients? On this note, are the patients aware enough of the risk attached to taking a combination of drugs which so far have no safety and efficacy results published on its behalf to date? You can read more about Fen-Phen here.

The idea behind the success of this combination is based on the fact that phentermine, an appetite suppressant, and Belviq, a drug that increases feelings of fullness, will likely produce substantial weight loss results considering both drugs work so differently on the appetite, and in combination, have the potential to be very powerful. However, there is the matter of the absence of safety and efficacy data available for the use of both drugs taken together. The reasoning behind this allowance is that, Belviq, which has no history of heart damage or associated cardiovascular related illness, was approved for use in 2012 and this, in combination with phentermine, which is not thought to have any impact on cardiovascular or pulmonary health, means that it has got to be a lot safer than the previous health hazard, Fen-Phen. Eisai, the marketers of Belviq, began a study of the combination of Belviq and phentermine back in October 2013 and results from a relatively short, 12 week study, have as yet to be released. I am sure physicians are waiting with bated breath, although, as it stands, this short study does not involve a placebo group and will not evaluate cardiac safety, based on the fact that Belviq was originally approved based on its cardiovascular safety. But, both physicians involved, and not involved directly in this study, are saying that the study is large enough to gauge whether or not this combination is safe, so, that’s a good sign? These physicians are also affiliated with the same research centre, perhaps this is worth mentioning. The potential risk of valvulopathy, the valve damage that Fen-Phen caused, has been mentioned though, and physicians outside of this research bubble say that this risk cannot be totally ruled out unless a larger study is carried out. It does seem like we are wandering blindly into another risky weight loss drug abyss where people may suffer unnecessarily before the study results evidence the combination’s viability, so, who do we trust?

Ideally doctors will be prescribing this combination on a person to person basis and will carry out a risk assessment based on the individual’s medical history, current weight and health but what if that is not enough. The reality is Fen-Phen just wasn’t safe and little did the medical community know at the time despite their scrupulousness in terms of FDA recommendation and study analysis. Hopefully, at the very least, these doctors will be explaining to their patients that this is not an FDA approved option and, as of yet, even short term safety results are not yet available. The decision to take this leap into the unknown should be made by patients who are informed, as desperate as they might be for a drug that will give them the best chances of shifting the dangerous weight they carry. It is an issue that will no doubt inspire great polarity of opinion among patients, physicians and pharmacists alike considering the potential for impressive results while also considering the Fen-Phen scare, which caused a multitude of cases of fatal pulmonary hypertension and heart valve damage. Even with doctors in the driving seat, please remember that Lorcaserin is likely to be available online. There are already UK companies that have added this product to their websites (even if they are not selling it yet!). One example can be found here. While we are not saying that this website is doing anything wrong, you can see how this could get out of control.

The doctors will have to bear the brunt of the responsibility of assessing patient risk on an individual basis. No doubt there will be many physicians who are wholeheartedly against experimenting with this combination for now, but at a time when there are few medications that suit every obese patient, patients are more desperate than ever to take what they can get in terms of successful weight loss treatments, despite the possible risk attached. Doctors, as well as patients, are under enormous pressure in this regard and it is a wonder that off-label prescribing is allowed at all. Perhaps it will transpire that there is no problem whatsoever with this particular combination but, we just don’t know yet. Until such a time as we do, maybe we should wait until such drug cocktails have been through rigorous and long term studies, providing peace of mind and positive results in the way of safety and efficacy. Where there was a lack of knowledge before regarding the Fen-Phen scandal, there is now, in its place, a shrewdness surely, that should have us testing to the highest standards before leaving such big decisions up to individual health practitioners. But maybe we haven’t learned our lesson at all….

As a footnote, please be aware that the license application for Lorcaserin in the EU has been withdrawn. It seems likely that the patent holder will come back at a later date, especially if there are no reported problems in the US. You can read the full statement on the withdrawal here.