Bariatric Physicians Question FDA for Not Approving New Diet Drug

Feb 20, 2011
Raechelle Janzen

Obesity in the US - Raechelle Janzen

Weight loss physicians are saying that the FDA seems to be holding bariatric drugs to a higher standard than drugs used primarily for other conditions.

The American Society of Bariatric Physicians has been publicly questioning the US Food and Drug Administration's recent decision to decline approving the diet new diet drug Contrave. This is the latest of three drugs in the last year or so that has been turned down by the Food and Drug Administration (FDA) for various reasons. The American Society of Bariatric Physicians says the drugs are being held to a higher standard than other drugs that treat different conditions such as diabetes and hypertension. It also says that the new lower BMI level requirements for the Lap Band surgical weight loss procedure recently approved by the FDA may be sending a bad message to obese patients.

FDA's Actions

The FDA declined to approve Contrave, but instead asked the manufacturer, Orexigen Therapeutics, to conduct a study "of sufficient size and duration" to examine the potential cardiovascular risks of the new diet drug, a combination of the medications naltrexone and bupropion HCL. The notice that the FDA had not approved Contrave came less than two months after the FDA Endocrinologic and Metabolic Drugs Advisory Committee gave their approval to Contrave, voting 13 to 7 in a December 7, 2010 meeting and commented that they felt the benefits would likely outweigh the risks.

Had Contrave been approved it would have been the first new diet drug in the past decade. The concern about the drug was that it seemed to increase blood pressure in certain patients who already had hypertension. Some say that the drug has similar properties to another diet drug Meridia, which was taken off the market last year due to its hypertensive issues in patients using it. There has been some discussion as to why Contrave could not have been approved for use in patients who do not have hypertension. Apparently, some physicians believe that that the FDA is being over cautious due to the cardiovascular issues the fen-phen combination weight loss drugs caused several years ago. They also say they question if the FDA is taking into consideration that there are also health risks with being obese.

Physicians' Reactions

What is very confusing to some of the physicians is that both Contrave and another rejected drug, Qnexa, are actually combinations of drugs that are already in use and apparently considered safe enough for other conditions. For whatever reason, the FDA is not allowing them to be used to treat obesity in patients. The doctors are questioning why the drug could not be used in obese patients who do not have high blood pressure. Medications used for other illnesses have certain restrictions placed on them that they have to follow. They are wondering why not these drugs.

The other two diet drugs that were recently not approved by the FDA panel were lorcaserin manufactured by Arena Pharmaceuticals and phentermine/controlled-release topiramate with the proposed name, Qnexa, Vivus.

No word yet if the makers of Contrave will follow up with the studies suggested by the FDA. They have already invested several billion dollars, and considering the rejection of the other weight loss drugs, it's not clear if they would want to invest even more money under the circumstances. Bariatric physicians hope that this doesn't discourage other drug companies from developing new drugs for weight loss in the future.