As we have previously been reporting, after a decade of anticipation and wonder, the future of some obese Americans may be looking a little better, as the FDA has now approved another diet pill. But, will it be the cure all that some hope for? Or will it ultimately be pulled from the market in a couple of years as its predecessors have in the past due to dangerous side effects that were warned from the beginning?
The pill is called, Lorcaserin, also known as Belviq, made by Arena Pharmaceuticals, and it was just approved by the FDA, but with much hesitation from many. As, Lorcaserin was originally turned down in 2010 over FDA scientists’ concerns that the drug carried heart-valve risks, which is a reoccurring problem that has also plagued the weight-loss drug fenfluramine, which was taken off the market.
In May 2012, after applying for approval again, and being sent to an FDA advisory committee for review, the review of Lorcaserin concluded that there was only a “negligible risk” of cancer and that preliminary trials showed no increased heart-valve risk, but the panel said that more study would be needed.
However, the panel concluded that Lorcaserin’s benefits outweighed its potential risks when used long-term in overweight and obese patients. The drug, which is meant to be used in combination with a healthy diet and exercise, triggers weight loss by influencing brain chemistry and giving dieters a feeling of fullness.
Armed with this information, in what they thought to be a last-ditch effort to keep yet another dangerous diet drug off the market, Public Citizen, a popular watchdog group wrote to FDA Commissioner Margaret Hamburg, warning her of the very negative consequences associated with Lorcaserin, and urging her not to approve it. They believed marketing this drug to a population besieged by obesity and desperate for relief is irresponsible and a mistake that will benefit only the company that makes it.
But, that’s not all.
They weren’t the only ones to openly disapprove; a recommendation against using diet drugs was published online in the Annals of Internal Medicine. Referring to currently marketed diet drugs, the U.S. Preventive Services Task Force concluded that because of safety problems and a lack of data showing that people can keep weight off after discontinuing diet medications, the task force could not recommend that anyone use diet drugs.
Therefore, although the FDA advisory committee voted to approve it, it did so reluctantly, particularly because of widely shared concerns about evidence of heart valve damage in people using the drug in clinical trials, Public Citizen’s letter to Hamburg said. This same adverse effect led the FDA to ban fenfluramine and dexfenfluramine, the “fen” components of Fen-Phen, in 1997.
When these last heart valve-damaging diet drugs were banned in 1997, the knowledge of this life-threatening adverse effect was known only after approval. But in this case, the FDA has known before the approval of Lorcaserin that it could damage heart valves. The agency’s own advisory committee concluded that “there’s probably not sufficient data at this time to rule out a clinically meaningful increase in the risk for valvular heart disease.”
Yet, despite all this, there is a new diet drug coming to drugstores near you.